Department of Health and MHRA Register of Licensed Manufacturing Sites 2015 MS and MANSA ONLY (Human and Veterinary Sites)

The information published in this Register was that held by the MHRA on the date of publication.

Please note the site register will be updated on a Monthly basis.

Date of Publication: AUGUST 2015

T 020 3080 6000 – www.mhra.gov.uk

NOTICES

The Agency’s register is computerised. Every Licence Holder and every licensed site has a unique number that should be quoted when enquiries are made about the register.

NOTES FOR GUIDANCE

GENERAL

The Licence Number is a specific number allocated to one company. The Site Number is a specific number allocated to one site.

LICENCE TYPE

MS - Manufacture Specials (Human) ManSA - Manufacturer ‘Specials’ Authorisation (Veterinary)

CONTENTS

SECTION 1 – HUMAN SECTION 2 - VETERINARY

Date of Publication 01 August 2015

SECTION 1 – HUMAN

Date of Publication: 01 August 2015 Register of Licensed Manufacturing Sites (Human)

Licence Holder MS 15643

A1 PHARMACEUTICALS UNIT 20/21, EASTER PARK, BEAM REACH 8, FERRY LANE, RAINHAM, UNITED KINGDOM, RM13 9BP

SITE ID : 352300 A1 PHARMACEUTICALS UNIT 20/21, EASTER PARK, BEAM REACH 8, FERRY LANE, RAINHAM, UNITED KINGDOM, RM13 9BP

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 1 of 147 Licence Holder MS 35930

ABERTAWE BRO MORGANNWG UNIVERSITY HEALTH BOARD ONE TALBOT GATEWAY, SEAWAY PARADE INDUSTRIAL ESTATE, SEAWAY DRIVE, PORT TALBOT, UNITED KINGDOM, SA12 7BR

SITE ID : 89033 PHARMACY TECHNICAL SERVICES & RADIOPHARMACY

SINGLETON HOSPITAL, SKETTY, SWANSEA, UNITED KINGDOM, SA2 8QA

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

SITE ID : 89441 PRE-PACKING UNIT, PHARMACY DEPARTMENT, NEATH\PORT TALBOT HOSPITAL NEATH/PORT TALBOT HOSPITAL, BAGLAN WAY, PRE-PACKING UNIT, PHARMACY DEPARTMENT, PORT TALBOT, UNITED KINGDOM, SA12 7BX

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS TABLETS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS

SITE ID : 90543 PUBLIC HEALTH LABORATORY SERVICE

SINGLETON HOSPITAL, SWANSEA, WEST GLAMORGAN, UNITED KINGDOM, SA2 8QA

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

SITE ID : 91420 QUALITY ASSURANCE AND CONTROL, PHARMACY DEPARTMENT, SINGLETON HOSPITAL SINGLETON HOSPITAL, SKETTY, SWANSEA, UNITED KINGDOM, SA2 8QA

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

SITE ID : 1898020 PHARMACEUTICAL SUPPORT SERVICES UNIT - MORRISTON HOSPITAL (MPSSU) MORRISTON HOSPITAL, HEOL MAES EGLWYS, MORRISTON, SWANSEA, UNITED KINGDOM, SA6 6NL

Date of Publication 01 August 2015 Human Only Page 2 of 147 Licence Holder MS 30346

AESICA FORMULATION DEVELOPMENT LIMITED BIOCITY, PENNYFOOT STREET, NOTTINGHAM, UNITED KINGDOM, NG1 1GF

SITE ID : 321374 AESICA FORMULATION DEVELOPMENT LIMITED BIOCITY, PENNYFOOT STREET, NOTTINGHAM, UNITED KINGDOM, NG1 1GF

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGDRY POWDER DOSAGE INHALER FORMS) DEVICES NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING DRY POWDER INHALER DEVICES PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING TABLETS

Licence Holder MS 5977

AINSWORTHS (LONDON) LIMITED 40-44 HIGH STREET, CATERHAM, UNITED KINGDOM, CR3 5UB

SITE ID : 16822 AINSWORTHS (LONDON) LIMITED

40-44 HIGH STREET, CATERHAM, UNITED KINGDOM, CR3 5UB

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 3 of 147 Licence Holder MS 16993

AINTREE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST PHARMACY DEPARTMENT, UNIVERSITY HOSPITAL AINTREE, LOWER LANE, LIVERPOOL, UNITED KINGDOM, L9 7AL

SITE ID : 30200 AINTREE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST

LOWER LANE, LIVERPOOL, UNITED KINGDOM, L9 7AL

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CYTOSTATICS, CYTOTOXICS, PENICILLINS, CEPHALOSPORINS

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 15929

AIR LIQUIDE LIMITED STATION ROAD, COLESHILL, BIRMINGHAM, UNITED KINGDOM, B46 1JY

SITE ID : 7308 AIR LIQUIDE - IRLAM

SORBY ROAD, NORTH BANK INDUSTRIAL PARK, IRLAM, MANCHESTER, UNITED KINGDOM, M44 5BA

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) MEDICINAL GASES SOLID NON-STERILE DOSAGE FORMS MEDICINAL GASES

PACKAGING ONLY PRIMARY PACKAGING MEDICINAL GASES

SITE ID : 89725 AIR LIQUIDE-ABERDEEN GREENBANK ROAD, EAST TULLOS INDUSTRIAL ESTATE, ABERDEEN, UNITED KINGDOM, AB12 3BQ

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) MEDICINAL GASES SOLID NON-STERILE DOSAGE FORMS MEDICINAL GASES

PACKAGING ONLY PRIMARY PACKAGING MEDICINAL GASES

Date of Publication 01 August 2015 Human Only Page 4 of 147 Licence Holder MS 4637

ALAN SPIVACK LIMITED 2ND FLOOR FRONT, HIGHGATE BUSINESS CENTRE, 33 GREENWOOD PLACE, LONDON, UNITED KINGDOM, NW5 1LB

SITE ID : 902686 ALAN SPIVACK LIMITED T\A ALAN PHARMACEUTICALS 2ND FLOOR FRONT, HIGHGATE BUSINESS CENTRE, 33 GREENWOOD PLACE, LONDON, UNITED KINGDOM, NW5 1LB

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 18351

ALCURA UK LIMITED UNIT 5 AND 6, GROVE PARK, MILL LANE, ALTON, UNITED KINGDOM, GU34 2QG

SITE ID : 10762 ALCURA UK LIMITED HRH HOUSE, MILL LANE, ALTON, UNITED KINGDOM, GU34 2QG

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 19054

ALIUM MEDICAL LIMITED UNIT 7, CAPITAL BUSINESS PARK, MANOR WAY, BOREHAMWOOD, UNITED KINGDOM, WD6 1GW

SITE ID : 340461 ALIUM MEDICAL LIMITED UNIT 7, CAPITAL BUSINESS PARK, MANOR WAY, BOREHAMWOOD, UNITED KINGDOM, WD6 1GW

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 5 of 147 Licence Holder MS 17087

ALLERGY THERAPEUTICS (UK) LIMITED DOMINION WAY, WORTHING, UNITED KINGDOM, BN14 8SA

SITE ID : 13114 ALLERGY THERAPEUTICS 2 UNIT A/B, DOMINION WAY, WORTHING, UNITED KINGDOM, BN14 8NW

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 30671 ALLERGY THERAPEUTICS (UK) LIMITED DOMINION WAY, WORTHING, UNITED KINGDOM, BN14 8SA

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES BIOLOGICAL ACTIVE STARTING MATERIALS OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Licence Holder MS 42609

ALLIANCE MEDICAL MOLECULAR IMAGING LIMITED UNIT 19, QUADRUM PARK, OLD PORTSMOUTH ROAD, PEASMARSH, GUILDFORD, UNITED KINGDOM, GU3 1LU

SITE ID : 407006 ALLIANCE MEDICAL MOLECULAR IMAGING LIMITED UNIT 19, QUADRUM PARK, OLD PORTSMOUTH ROAD, PEASMARSH, GUILDFORD, UNITED KINGDOM, GU3 1LU

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 6 of 147 Licence Holder MS 22443

ALLIANCE MEDICAL RADIOPHARMACY LIMITED ICENI CENTRE, WARWICK TECHNOLOGY PARK, GALLOWS HILL, WARWICK, UNITED KINGDOM, CV34 6DA

SITE ID : 114424 ALLIANCE MEDICAL RADIOPHARMACY LIMITED KEELE UNIVERSITY SCIENCE PARK, KEELE, UNITED KINGDOM, ST5 5BX

OTHER TERMINALLY STERILISED PREPARED STERILE PRODUCTS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGPRODUCTS DOSAGE RADIOPHARMACEUTICALS FORMS) TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 479651 ALLIANCE MEDICAL RADIOPHARMACY LIMITED ROYAL PRESTON HOSPITAL, SHAROE GREEN LANE, FULWOOD, PRESTON, UNITED KINGDOM, PR2 9HT

SITE ID : 926769 ALLIANCE MEDICAL RADIOPHARMACY LIMITED

ROYAL MARSDEN HOSPITAL, DOWNS ROAD, SUTTON, UNITED KINGDOM, SM2 5PT

OTHER TERMINALLY STERILISED PREPARED STERILE PRODUCTS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGPRODUCTS DOSAGE RADIOPHARMACEUTICALS FORMS) (SMALL VOLUME LIQUIDS) TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 20377

ALMAC CLINICAL SERVICES LIMITED 9 CHARLESTOWN ROAD, SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, UNITED KINGDOM, BT63 5PW

SITE ID : 13423 ALMAC CLINICAL SERVICES LIMITED

SEAGOE INDUSTRIAL ESTATE, 9 CHARLESTOWN ROAD, CRAIGAVON, UNITED KINGDOM, BT63 5PW

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING SOFT GELATIN CAPSULES AND SUPPOSITORIES PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS PRIMARY PACKAGING TRANSDERMAL PATCHES

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 7 of 147 Licence Holder MS 20782

ALMAC PHARMA SERVICES LIMITED ALMAC HOUSE, 20 SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, UNITED KINGDOM, BT63 5QD

SITE ID : 15328 ALMAC PHARMA SERVICES LIMITED SEAGOE INDUSTRIAL ESTATE, PORTADOWN, CRAIGAVON, UNITED KINGDOM, BT63 5UA

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL OTHER NON-STERILE MEDICINAL PRODUCTS OTHER SOLID DOSAGE FORMS INCLUDE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGPOWDERS, DOSAGE GRANULES, FORMS) PENICILLIN POWDERS AND PENICILLIN GRANULES. CAPSULES HARD SHELL AND TABLETS INCLUDES PENICILLINS. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 27797

AMERICAN BIOCHEMICAL AND PHARMACEUTICALS LIMITED GLOBAL HOUSE, 1 ASHLEY AVENUE, EPSOM, UNITED KINGDOM, KT18 5AD

SITE ID : 118978 AMERICAN BIOCHEMICAL AND PHARMACEUTICALS LIMITED

GLOBAL HOUSE, 1 ASHLEY AVENUE, EPSOM, UNITED KINGDOM, KT18 5AD

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 42922

AMILCO LIMITED MCKENZIE HOUSE, BURY STREET, RUISLIP, UNITED KINGDOM, HA4 7TL

SITE ID : 875953 AMILCO LIMITED MCKENZIE HOUSE, BURY STREET, RUISLIP, UNITED KINGDOM, HA4 7TL

STERILE PRODUCTS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 8 of 147 Licence Holder MS 11724

ANDERSONBRECON (UK) LIMITED PHAROS HOUSE, WYE VALLEY BUSINESS PARK, BRECON PARK, BRECON ROAD, HAY-ON-WYE, HEREFORD, UNITED KINGDOM, HR3 5PG

SITE ID : 114445 ANDERSONBRECON (UK) LIMITED

UNITS 2-7, WYE VALLEY BUSINESS PARK, BRECON ROAD, HAY-ON-WYE, HEREFORD, UNITED KINGDOM, HR3 5PG

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING CHEWING GUMS PRIMARY PACKAGING IMPREGNATED MATRICES PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING INJECTIONS, SPRAYS & INHALERS WITH AND WITHOUT PROPELLANT. PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 4791755 ANDERSONBRECON (UK) LIMITED UNIT 8.3, MAIN AVENUE, TREFOREST INDUSTRIAL ESTATE, PONTYPRIDD, UNITED KINGDOM, CF37 5UR

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS TERMINALLY STERILISED PRODUCTS

Date of Publication 01 August 2015 Human Only Page 9 of 147 Licence Holder MS 1175

A NELSON AND COMPANY LIMITED NELSONS HOUSE, 83 PARKSIDE, WIMBLEDON, LONDON, UNITED KINGDOM, SW19 5LP

SITE ID : 2404 A NELSON AND COMPANY LIMITED UNIT 1, UNIT 5-9 ENDEAVOUR WAY, LONDON, UNITED KINGDOM, SW19 8UH

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS SOLID NON-STERILE MULTI DOSE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) (INCLUDING POWDERS AND GRANULES), PILLULES NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS TABLETS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

Licence Holder MS 35932

ANEURIN BEVAN UNIVERSITY HEALTH BOARD THE ROYAL GWENT HOSPITAL, CARDIFF ROAD, NEWPORT, UNITED KINGDOM, NP20 2UB

SITE ID : 21112 ANEURIN BEVAN LOCAL HEALTH BOARD THE ROYAL GWENT HOSPITAL, CARDIFF ROAD, NEWPORT, UNITED KINGDOM, NP20 2UB

PACKAGING ONLY PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING TABLETS

Date of Publication 01 August 2015 Human Only Page 10 of 147 Licence Holder MS 42760

ARCADIA PHARMA LIMITED UNIT 3, BELL COURT, SWANSEA WEST BUSINESS PARK, FELINFACH, FFORESTFACH, SWANSEA, UNITED KINGDOM, SA5 4HP

SITE ID : 9100985 ARCADIA PHARMA LIMITED UNIT 3, BELL COURT, SWANSEA WEST BUSINESS PARK, FELINFACH, FFORESTFACH, SWANSEA, UNITED KINGDOM, SA5 4HP

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING TABLETS

Licence Holder MS 18646

ARCHIMEDES DEVELOPMENT LIMITED ALBERT EINSTEIN CENTRE, NOTTINGHAM SCIENCE & TECHNOLOGY PARK, UNIVERSITY BOULEVARD, NOTTINGHAM, UNITED KINGDOM, NG7 2TN

SITE ID : 11149 ARCHIMEDES DEVELOPMENT LIMITED ALBERT EINSTEIN CENTRE, NOTTINGHAM SCIENCE & TECHNOLOGY PARK, UNIVERSITY BOULEVARD, NOTTINGHAM, UNITED KINGDOM, NG7 2TN

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS VACCINES, HORMONES

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS CREAMS, OINTMENTS AND GELS, SOLID NON-STERILE MULTI-DOSE FORMS (POWDERS AND GRANULES), POWDERS UNIT DOSE FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGFOR NASAL DOSAGE DELIVERY, FORMS) SOLID NON-STERILE UNIT DOSE FORMS (STARCH CAPSULES), PACKAGING: SOLID DOSAGE FORMS INCLUDING CAPSULES NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 11 of 147 Licence Holder MS 39541

ASCOT LABORATORIES LIMITED UNIT 1, OLDS APPROACH, WATFORD, UNITED KINGDOM, WD18 9TD

SITE ID : 7765098 ASCOT PHARMA LIMITED UNIT 1, OLDS APPROACH INDUSTRIAL ESTATE, OLDS APPROACH, WATFORD, UNITED KINGDOM, WD18 9TD

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE SOFT FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGDRY POWDER DOSAGE SACHETS FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS)

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 8977

ASPAR PHARMACEUTICALS LIMITED 29-30 CAPITOL WAY, CAPITOL WAY INDUSTRIAL PARK, COLINDALE, LONDON, UNITED KINGDOM, NW9 0EQ

SITE ID : 18369 ASPAR PHARMACEUTICALS LIMITED

29-30 CAPITOL WAY, CAPITOL WAY INDUSTRIAL PARK, COLINDALE, LONDON, UNITED KINGDOM, NW9 0EQ

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

Date of Publication 01 August 2015 Human Only Page 12 of 147 Licence Holder MS 17901

ASTRAZENECA UK LIMITED 600 CAPABILITY GREEN, LUTON, UNITED KINGDOM, LU1 3LU

SITE ID : 10117 ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLESFIELD, UNITED KINGDOM, SK10 2NA

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS

NON-STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGANTIOESTROGEN DOSAGE FORMS) (TABLETS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING SEMI-SOLIDS

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS

ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ASEPTICALLY FORMS) PREPARED PRODUCTS LHRA AGONIST (SOLID AND IMPLANTS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSOLIDS DOSAGE AND IMPLANTS FORMS) BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS TERMINALLY STERILISED PRODUCTS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 4425

AVENTIS PHARMA LIMITED ONE ONSLOW STREET, GUILDFORD, UNITED KINGDOM, GU1 4SY

SITE ID : 2376 SANOFI-SYNTHELABO LIMITED CHAPELTOWN DISTRIBUTION CENTRE, 51 CART ROAD, CHAPELTOWN, SHEFFIELD, UNITED KINGDOM, S35 2PF

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 13 of 147 Licence Holder MS 1811

BARD PHARMACEUTICALS LIMITED CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, UNITED KINGDOM, CB4 0AB

SITE ID : 21989 BARD PHARMACEUTICALS LIMITED UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, UNITED KINGDOM, CB4 0GW

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) GRANULES FOR SUSPENSION. NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Licence Holder MS 21369

BARKING, HAVERING & REDBRIDGE UNIVERSITY HOSPITALS NHS TRUST ROM VALLEY WAY, ROMFORD, UNITED KINGDOM, RM7 0AG

SITE ID : 300706 BARKING, HAVERING & REDBRIDGE UNIVERSITY HOSPITALS NHS TRUST ROM VALLEY WAY, ROMFORD, UNITED KINGDOM, RM7 0AG

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING TABLETS

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS INCLUDE ANTIBIOTICS, ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) RADIOPHARMACEUTICALS, CYTOTOXICS, PARENTERAL NUTRITION. ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 12823

BARNSLEY HOSPITAL NHS FOUNDATION TRUST GAWBER ROAD, BARNSLEY, UNITED KINGDOM, S75 2EP

SITE ID : 90390 MEDICAL PHYSICS DEPARTMENT BARNSLEY DISTRICT GENERAL HOSPITAL, GAWBER ROAD, BARNSLEY, UNITED KINGDOM, S75 2EP

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 14 of 147 Licence Holder MS 14620

BARTS HEALTH NHS TRUST 80 NEWARK STREET, WHITECHAPEL, LONDON, UNITED KINGDOM, E1 2ES

SITE ID : 21233 WHIPPS CROSS UNIVERSITY HOSPITAL NHS TRUST WHIPPS CROSS ROAD, LEYTONSTONE, LONDON, UNITED KINGDOM, E11 1NR

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

SITE ID : 291909 ROYAL LONDON HOSPITAL PHARMACY TECHNICAL SERVICES, PATHOLOGY & PHARMACY BUILDING, 80 NEWARK STREET, WHITECHAPEL, LONDON, UNITED KINGDOM, E1 2ES

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS GENE THERAPY PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS MONOCLONAL ANTIBODIES

PACKAGING ONLY PRIMARY PACKAGING TABLETS PRIMARY PACKAGING TRANSDERMAL PATCHES

SITE ID : 11383121 BARTS HEALTH NHS TRUST (PHARMACY CHEMOTHERAPY UNIT 7TH FLOOR) DEPARTMENT OF PHARMACY- PHARMACY CHEMOTHERAPY UNIT AND BARTS RADIOPHARMACY, KING GEORGE V WING- NUCLEAR MEDICINE, ST BARTHOLOMEW'S HOSPITAL, WEST SMITHFIELD, LONDON, UNITED KINGDOM, EC1A 7BE

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS GENE THERAPY PRODUCTS

BIOLOGICAL MEDICINAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS MONOCLONAL ANTIBODIES

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

OTHER PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES RADIOPHARMACEUTICALS/RADIONUCLIDE GENERATORS

Date of Publication 01 August 2015 Human Only Page 15 of 147 Licence Holder MS 21371

BASILDON & THURROCK UNIVERSITY HOSPITALS NHS FOUNDATION TRUST NETHERMAYNE, BASILDON HOSPITAL, NETHERMAYNE, BASILDON, UNITED KINGDOM, SS16 5NL

SITE ID : 89662 PHARMACY NSPU, ORSETT HOSPITAL ROWLEY ROAD, ORSETT HOSPITAL, ORSETT, GRAYS, UNITED KINGDOM, RM16 3EU

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS PREPACKING OF INJECTABLE PRODUCTS. PRIMARY PACKAGING MANUFACTURER'S PRIMARY PACKAGING NOT BREACHED. PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

SITE ID : 90022 BASILDON & THURROCK UNIVERSITY HOSPITALS NHS FUNDATION TRUST NETHERMAYNE, BASILDON HOSPITAL, NETHERMAYNE, BASILDON, UNITED KINGDOM, SS16 5NL

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

Date of Publication 01 August 2015 Human Only Page 16 of 147 Licence Holder MS 116

BAXTER HEALTHCARE LIMITED CAXTON WAY, THETFORD, UNITED KINGDOM, IP24 3SE

SITE ID : 18507 BAXTER HEALTHCARE LIMITED CAXTON WAY, THETFORD, UNITED KINGDOM, IP24 3SE

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS ANTIVIRALS, NON-CYTOTOXIC AND CYTOTOXIC MONOCLONAL ANTIBODIES

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGCYTOTOXICS, DOSAGE ANTIBIOTICS FORMS) INCLUDING PENICILLINS AND CEPHALOSPORINS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 28970 ASEPTIC COMPOUNDING UNIT, MOUNT VERNON HOSPITAL RICKMANSWORTH ROAD, NORTHWOOD, UNITED KINGDOM, HA6 2RN

SITE ID : 90119 BAXTER HEALTHCARE LIMITED

HEATON CHAPEL, UNIT 1, BOUNDARY COURT, CROSSLEY ROAD, STOCKPORT, UNITED KINGDOM, SK4 5GA

Date of Publication 01 August 2015 Human Only Page 17 of 147 SITE ID : 525104 BAXTER HEALTHCARE LIMITED UNIT B, TAURUS BUILDING, PETERLEY ROAD, COWLEY, OXFORD, UNITED KINGDOM, OX4 2TZ

Licence Holder MS 4296

B BRAUN MEDICAL LIMITED THORNCLIFFE PARK, SHEFFIELD, SOUTH YORKSHIRE, UNITED KINGDOM, S35 2PW

SITE ID : 15286 B BRAUN MEDICAL LIMITED BROOKDALE ROAD, THORNCLIFFE PARK ESTATE, CHAPELTOWN, SHEFFIELD, UNITED KINGDOM, S35 2PW

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS AND SMALL VOLUME LIQUIDS INCLUDE CYTOTOXICS. ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 34777

BCM SPECIALS LIMITED 1 THANE ROAD WEST, NOTTINGHAM, UNITED KINGDOM, NG2 3AA

SITE ID : 120399 BCM LIMITED THANE ROAD, BEESTON, NOTTINGHAM, UNITED KINGDOM, NG90 2PR

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS

NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE NON-STERILE FORMS) MEDICINAL PRODUCTS POWDERS. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS)

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 18 of 147 Licence Holder MS 32485

BELFAST HEALTH AND SOCIAL CARE TRUST FIRST FLOOR, KING EDWARD BUILDING, THE ROYAL HOSPITALS, GROSVENOR ROAD, BELFAST, UNITED KINGDOM, BT12 6BA

SITE ID : 333727 BELFAST HEALTH AND SOCIAL CARE TRUST - CYCLOTRON PRODUCTION FACILITY LEVEL 1 IMAGING CENTRE, ROYAL VICTORIA HOSPITAL, GROSVENOR ROAD, BELFAST, UNITED KINGDOM, BT12 6BA

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 1226848 REGIONAL RADIOPHARMACY, ROYAL VICTORIA HOSPITAL FERGUSON BUILDING, ROYAL VICTORIA HOSPITAL, GROSVENOR ROAD, BELFAST, UNITED KINGDOM, BT12 6BA

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGANTIOBIOTICS, DOSAGE FORMS)CYTOTOXICS AND CYTOKINE MODULATORS BNF 10.1.3 ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 1683129 THE PLENUM BUILDING, VICTORIA PHARMACEUTICALS AND REGIONAL QUALITY ASSURANCE SERVICE ROYAL GROUP OF HOSPITALS SITE, GROSVENOR ROAD, BELFAST, UNITED KINGDOM, BT12 6BA

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE SOFT FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING PRESSURISED PREPARATIONS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGANTIBIOTICS, DOSAGE CYTOTOXICS FORMS) AND CYTOKINE MODULATORS BNF 10.1.3 ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 19 of 147 Licence Holder MS 35931

BETSI CADWALADR UNIVERSITY LOCAL HEALTH BOARD PHARMACY DEPARTMENT, WREXHAM MAELOR HOSPITAL, CROESNEWYDD ROAD, WREXHAM, UNITED KINGDOM, LL13 7TD

SITE ID : 9946 WREXHAM MAELOR HOSPITAL NHS TRUST

CROESNEWYDD ROAD, WREXHAM, UNITED KINGDOM, LL13 7TD

SITE ID : 9965 GLAN CLWYD HOSPITAL GLAN CLWYD HOSPITAL, BODELWYDDAN, RHYL, UNITED KINGDOM, LL18 5UJ

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING PREPARATION OF EMERGENCY BOXES PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS

Licence Holder MS 36296

BIONICAL LIMITED THE BOARDWALK, MERCIA MARINA, FINDERN LANE, WILLINGTON, DERBY, UNITED KINGDOM, DE65 6DW

SITE ID : 7066525 BIONICAL LIMITED UNIT 7, BRUNEL DRIVE, STRETTON, BURTON-ON-TRENT, UNITED KINGDOM, DE13 0BY

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 20 of 147 Licence Holder MS 8801

BIO PRODUCTS LABORATORY LIMITED DAGGER LANE, ELSTREE, HERTFORDSHIRE, UNITED KINGDOM, WD6 3BX

SITE ID : 18235 BIO PRODUCTS LABORATORY LIMITED DAGGER LANE, ELSTREE, BOREHAMWOOD, UNITED KINGDOM, WD6 3BX

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES BIOLOGICAL ACTIVE STARTING MATERIALS

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLYOPHILISATES DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 21 of 147 Licence Holder MS 19819

BIOTEC SERVICES INTERNATIONAL LIMITED BIOTEC HOUSE, CENTRAL PARK, WESTERN AVENUE, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, UNITED KINGDOM, CF31 3RT

SITE ID : 504747 BIOTEC SERVICES INTERNATIONAL LIMITED BIOTEC HOUSE, CENTRAL PARK, WESTERN AVENUE, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, UNITED KINGDOM, CF31 3RT

SITE ID : 4680309 BIOTEC SERVICES INTERNATIONAL LIMITED UNITS 2100, 2110, 2010, 2120 AND 2130, PHASE 18, CENTRAL PARK, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, UNITED KINGDOM, CF31 3TY

NON-STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS NON-STERILE PRODUCTS

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES BIOLOGICAL ACTIVE STARTING MATERIALS OTHER MANUFACTURING/IMPORT ACTIVITIES MEDICINAL GASES RADIOPHARMACEUTICALS/RADIONUCLIDE OTHER MANUFACTURING/IMPORT ACTIVITIES GENERATORS OTHER SPECIFIC PROCESSES/ACTIVITIES AIRLINE KITS OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS TERMINALLY STERILISED PRODUCTS

Licence Holder MS 735

BOC LIMITED THE PRIESTLEY CENTRE, 10, PRIESTLEY ROAD, SURREY RESEARCH PARK, GUILDFORD, UNITED KINGDOM, GU2 5XY

SITE ID : 661963 BOC LIMITED 28 DEER PARK ROAD, LONDON, UNITED KINGDOM, SW19 3UF

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) MEDICINAL GASES SOLID NON-STERILE DOSAGE FORMS MEDICINAL GASES

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 22 of 147 Licence Holder MS 11429

BRADFORD TEACHING HOSPITALS NHS FOUNDATION TRUST DUCKWORTH LANE, BRADFORD, UNITED KINGDOM, BD9 6RJ

SITE ID : 27506 BRADFORD TEACHING HOSPITALS NHS FOUNDATION TRUST DUCKWORTH LANE, BRADFORD, UNITED KINGDOM, BD9 6RJ

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 11902

BREAKSPEAR MEDICAL GROUP LTD HERTFORDSHIRE HOUSE, WOOD LANE,PARADISE ESTATE, HEMEL HEMPSTEAD, UNITED KINGDOM, HP2 4FD

SITE ID : 90191 BREAKSPEAR MEDICAL GROUP LTD HERTFORDSHIRE HOUSE, WOOD LANE,PARADISE ESTATE, HEMEL HEMPSTEAD, UNITED KINGDOM, HP2 4FD

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 21378

BRIGHTON & SUSSEX UNIVERSITY HOSPITALS NHS TRUST ROYAL SUSSEX COUNTY HOSPITAL, EASTERN ROAD, BRIGHTON, UNITED KINGDOM, BN2 5BE

SITE ID : 374105 BRIGHTON & SUSSEX UNIVERSITY HOSPITALS NHS TRUST NUCLEAR MEDICINE DEPARTMENT, ROYAL SUSSEX COUNTY HOSPITAL, EASTERN ROAD, BRIGHTON, UNITED KINGDOM, BN2 5BE

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES OTHER RADIOACTIVE MATERIALS

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) OTHER ASEPTICALLY PREPARED PRODUCTS RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 23 of 147 Licence Holder MS 11184

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMITED BMS HOUSE, UXBRIDGE BUSINESS PARK, SANDERSON ROAD, UXBRIDGE, UNITED KINGDOM, UB8 1DH

SITE ID : 7051 BRISTOL-MYERS SQUIBB PHARMACEUTICALS LIMITED REEDS LANE MORETON, WIRRAL, UNITED KINGDOM, CH46 1QW

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 12675

BUPA HOME HEALTHCARE LIMITED UNIT 4 SCIMITAR PARK, ROYDON ROAD, HARLOW, UNITED KINGDOM, CM19 5GU

SITE ID : 90347 BUPA HOME HEALTHCARE LIMITED OFF STATION ROAD, UNIT 3, STONEY GATE ROAD, SPONDON, UNITED KINGDOM, DE21 7RX

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ANTIBIOTICS FORMS) AND ANTIFUNGALS, OTHER AGENTS AND CYTOTOXIC PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 286547 BUPA HOME HEALTHCARE LIMITED UNITS 3 AND 4, SPIRE GREEN CENTRE, FLEX MEADOW, THE PINNACLES, HARLOW, UNITED KINGDOM, CM19 5TR

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ANTIBIOTICS FORMS) AND ANTIFUNGALS, OTHER AGENTS AND CYTOTOXIC PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 24 of 147 Licence Holder MS 12745

BURTON HOSPITALS NHS FOUNDATION TRUST PHARMACY MANUFACTURING UNIT, QUEENS HOSPITAL, BELVEDERE ROAD, BURTON-ON-TRENT, UNITED KINGDOM, DE13 0RB

SITE ID : 3337 BURTON HOSPITALS NHS FOUNDATION TRUST PHARMACY MANUFACTURING UNIT, QUEENS HOSPITAL, BELVEDERE ROAD, BURTON-ON-TRENT, UNITED KINGDOM, DE13 0RB

PACKAGING ONLY PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER TERMINALLY STERILISED PREPARED TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGPRODUCTS DOSAGE PROFLAVINE FORMS) DRESSINGS, RIBBON GAUZE IN WHITE SOFT PARAFFIN TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 19055

CALDERDALE AND HUDDERSFIELD NHS FOUNDATION TRUST ACRE MILLS, GATE 2, SCHOOL STREET WEST, LINDLEY, HUDDERSFIELD, UNITED KINGDOM, HD3 3ET

SITE ID : 431097 CALDERDALE AND HUDDERSFIELD NHS FOUNDATION TRUST ACRE MILLS, GATE 2, SCHOOL STREET WEST, LINDLEY, HUDDERSFIELD, UNITED KINGDOM, HD3 3ET

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING TABLETS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 25 of 147 Licence Holder MS 18542

CALEA UK LIMITED CESTRIAN COURT, EASTGATE WAY, MANOR PARK, RUNCORN, UNITED KINGDOM, WA7 1NT

SITE ID : 261266 FRESENIUS KABI LIMITED CESTRIAN COURT, EASTGATE WAY, MANOR PARK, RUNCORN, UNITED KINGDOM, WA7 1NT

OTHER BIOLOGICAL MEDICINAL PRODUCTS PENICILLINS, CEPHALOSPORINS, OTHER BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS ANTIBIOTICS, HORMONES, CYTOSTATICS/CYTOTOXICS

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

Licence Holder MS 36474

CALIGOR RX LIMITED UNIT 23, SCHOONER PARK, SCHOONER COURT, CROSSWAYS BUSINESS PARK, DARTFORD, UNITED KINGDOM, DA2 6NW

SITE ID : 6449005 CALIGOR RX LIMITED UNIT 23, SCHOONER PARK, SCHOONER COURT, CROSSWAYS BUSINESS PARK, DARTFORD, UNITED KINGDOM, DA2 6NW

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 12854

CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST ADDENBROOKES HOSPITAL, BOX 104, INPATIENT PHARMACY, HILLS ROAD, CAMBRIDGE, UNITED KINGDOM, CB2 0QQ

SITE ID : 425537 CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST RADIOPHARMACY, DEPARTMENT OF NUCLEAR MEDICINE, ADDENBROOKES HOSPITAL, HILLS ROAD, CAMBRIDGE, UNITED KINGDOM, CB2 0QQ

PACKAGING ONLY PRIMARY PACKAGING RADIONUCLIDE GENERATORS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES OTHER RADIOPHARMACEUTICALS.

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 26 of 147 Licence Holder MS 35929

CARDIFF AND VALE UNIVERSITY LOCAL HEALTH BOARD UNIVERSITY HOSPITAL OF WALES, HEATH PARK, CARDIFF, UNITED KINGDOM, CF14 4XW

SITE ID : 91512 PARENTERAL SERVICES UNIT, PHARMACY DEPARTMENT, LLANDOUGH HOSPITAL PENLAN ROAD, CARDIFF AND VALE NHS TRUST, PENARTH, UNITED KINGDOM, CF64 2XX

SITE ID : 92664 MEDICAL PHYSICS DEPARTMENT HEATH PARK, UNIVERSITY HOSPITAL OF WALES, CARDIFF, UNITED KINGDOM, CF14 4XW

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 1113205 CARDIFF AND VALE UNIVERSITY LOCAL HEALTH BOARD ST MARY'S PHARMACEUTICAL UNIT, 20 FIELD WAY, CARDIFF, UNITED KINGDOM, CF14 4HY

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING CHEWING GUMS PRIMARY PACKAGING IMPREGNATED MATRICES PRIMARY PACKAGING TABLETS PRIMARY PACKAGING TRANSDERMAL PATCHES

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 27 of 147 Licence Holder MS 21323

CARDIFF UNIVERSITY WALES RESEARCH AND DIAGNOSTIC POSITRON EMISSION TOMOGRAPHY (PET) CENTRE, SCHOOL OF MEDICINE, HEATH PARK, CARDIFF, UNITED KINGDOM, CF14 4XN

SITE ID : 1965445 CARDIFF UNIVERSITY WALES RESEARCH AND DIAGNOSTIC POSITRON EMISSION TOMOGRAPHY (PET) CENTRE, SCHOOL OF MEDICINE, HEATH PARK, CARDIFF, UNITED KINGDOM, CF14 4XN

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGMEDICINAL DOSAGE GASES FORMS)

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES MEDICINAL GASES

OTHER MANUFACTURING/IMPORT ACTIVITIES RADIOPHARMACEUTICALS/RADIONUCLIDE GENERATORS

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 28 of 147 Licence Holder MS 25274

CATALENT CTS (EDINBURGH) LIMITED UNIT 107 TENTH AVENUE, DEESIDE INDUSTRIAL PARK, DEESIDE, UNITED KINGDOM, CH5 2UA

SITE ID : 5143 CATALENT CTS (EDINBURGH) LIMITED - DEESIDE UNIT 107 UNIT 107 TENTH AVENUE, DEESIDE INDUSTRIAL PARK, DEESIDE, UNITED KINGDOM, CH5 2UA

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS TYPE OF PRODUCT TO BE ASSEMBLED IS CLIENT OR CONTRACT DEPENDANT. ALL PRODUCT TYPES MAY BE ASSEMBLED WITH THE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGEXEPTION DOSAGE OF PENICILLINS FORMS) AND CEPHALOSPORINS. PACKAGING: LABELLING OF PRIMARY CONTAINERS OF AEROSOLS (PRESSURISED) OR SPRAYS (PRESSURISED OR NON-PRE

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 29333 CATALENT CTS (EDINBURGH) LIMITED INCHWOOD, BATHGATE, UNITED KINGDOM, EH48 2EH

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING PESSARIES PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

SITE ID : 90874 CATALENT CTS (EDINBURGH) LIMITED - DEESIDE UNIT 103 UNIT 103, PARKWAY, DEESIDE INDUSTRIAL PARK, DEESIDE, UNITED KINGDOM, CH5 2NS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 29 of 147 Licence Holder MS 1380

CATALENT UK PACKAGING LIMITED LANCASTER WAY, WINGATES INDUSTRIAL PARK, WESTHOUGHTON, BOLTON, UNITED KINGDOM, BL5 3XX

SITE ID : 31218 CATALENT UK PACKAGING LIMITED LANCASTER WAY, WINGATES INDUSTRIAL ESTATE, WESTHOUGHTON, BOLTON, UNITED KINGDOM, BL5 3XX

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING CHEWING GUMS PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS OVER ENCAPSULATION OF PRODUCT, ANTIBIOTICS OTHER THAN PENICILLINS AND PRIMARY PACKAGING CEPHALOSPORINS. CYTOSTATICS, CYTOTOXICS, HORMONE PRODUCTS MAY UNDERGO PRIMARY PACKAGING PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS PRIMARY PACKAGING TRANSDERMAL PATCHES

Licence Holder MS 21752

CELGENE EUROPE LIMITED 1 LONGWALK ROAD, STOCKLEY PARK, UXBRIDGE, UNITED KINGDOM, UB11 1DB

SITE ID : 2907930 CELGENE EUROPE LIMITED

1 LONGWALK ROAD, STOCKLEY PARK, UXBRIDGE, UNITED KINGDOM, UB11 1DB

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 30 of 147 Licence Holder MS 44168

CELLULAR THERAPEUTICS LIMITED 48 GRAFTON STREET, MANCHESTER, UNITED KINGDOM, M13 9XX

SITE ID : 21915 CELLULAR THERAPEUTICS LIMITED 48 GRAFTON STREET, MANCHESTER, UNITED KINGDOM, M13 9XX

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS GENE THERAPY PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS AUTOLOGOUS CELLULAR THERAPIES USING CELLS EXTRACTED FROM HUMAN TISSUE PRIOR BIOLOGICAL MEDICINAL PRODUCTS TO MANIPULATION. THE FINAL PRODUCT IS MADE UP AS A CELL SUSPENSION FOR RE-INFUSION

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGAUTOLOGOUS DOSAGE CELLULARFORMS) THERAPIES FOR DIRECT INFUSION ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 21387

CENTRAL MANCHESTER UNIVERSITY HOSPITALS NHS FOUNDATION TRUST RADIOPHARMACY UNIT, NUCLEAR MEDICINE CENTRE, CENTRAL MANCHESTER UNIVERSITY HOSPITALS NHS FOUNDATION TRUST, OXFORD ROAD, MANCHESTER, UNITED KINGDOM, M13 9WL

SITE ID : 1286081 CENTRAL MANCHESTER UNIVERSITY HOSPITALS NHS FOUNDATION TRUST RADIOPHARMACY UNIT, NUCLEAR MEDICINE CENTRE, OXFORD ROAD, MANCHESTER, UNITED KINGDOM, M13 9WL

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) RADIOMEDICINAL; RADIOPHARMACEUTICALS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS TABLETS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) OTHER ASEPTICALLY PREPARED PRODUCTS RADIOMEDICINAL; RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 31 of 147 Licence Holder MS 16260

CEPHALON UK LIMITED ALBANY PLACE, HYDE WAY, WELWYN GARDEN CITY, UNITED KINGDOM, AL7 3BT

SITE ID : 6963 ALLOGA UK LIMITED AMBER PARK 1, 2, AND 3, BERRISTOW LANE, SOUTH NORMANTON, ALFRETON, UNITED KINGDOM, DE55 2FH

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 382983 CEPHALON UK LIMITED ALBANY PLACE, HYDE WAY, WELWYN GARDEN CITY, UNITED KINGDOM, AL7 3BT

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 12896

CHESTERFIELD ROYAL HOSPITAL NHS FOUNDATION TRUST CHESTERFIELD ROAD, CALOW, CHESTERFIELD, UNITED KINGDOM, S44 5BL

SITE ID : 88984 MEDICAL PHYSICS DEPARTMENT CHESTERFIELD ROYAL HOSPITAL NHS FOUNDATION TRUST, CHESTERFIELD, UNITED KINGDOM, S44 5BL

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS RADIOACTIVE MATERIALS

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

SITE ID : 89490 PHARMACY DEPARTMENT

CHESTERFIELD ROYAL HOSPITAL NHS FOUNDATION TRUST, CHESTERFIELD, UNITED KINGDOM, S44 5BL

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS IMMUNOGLOBULIN INFUSIONS (BB); INFLIXIMAB, RIFUXIMAB, ALEMTUZUMAB (BO).

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 32 of 147 Licence Holder MS 18756

CHESTER MEDICAL SOLUTIONS UNITS 3-4 APEX COURT, BASSENDALE ROAD, BROOMBOROUGH, UNITED KINGDOM, CH62 3RE

SITE ID : 91541 CHESTER MEDICAL SOLUTIONS UNITS 3,4,7 & 8, APEX COURT, BASSENDALE ROAD, BROMBOROUGH, UNITED KINGDOM, CH62 3RE

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING CHEWING GUMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT

Licence Holder MS 21266

CHRISTIE NHS FOUNDATION TRUST NORTH WESTERN MEDICAL PHYSICS, CHRISTIE HOSPITAL NHS FOUNDATION TRUST, WILMSLOW ROAD, WITHINGTON, MANCHESTER, UNITED KINGDOM, M20 4BX

SITE ID : 88982 CHRISTIE MEDICAL PHYSICS AND ENGINEERING NORTH WESTERN MEDICAL PHYSICS, CHRISTIE HOSPITAL NHS FOUNDATION TRUST, WILMSLOW ROAD, WITHINGTON, MANCHESTER, UNITED KINGDOM, M20 4BX

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS RADIOPHARMACEUTICAL PRODUCTS.

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES OTHER RADIOACTIVE MATERIALS.

Date of Publication 01 August 2015 Human Only Page 33 of 147 Licence Holder MS 13683

CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST SUNDERLAND ROYAL HOSPITAL, KAYLL ROAD, SUNDERLAND, UNITED KINGDOM, SR4 7TP

SITE ID : 10677 CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST - GATESHEAD RADIOPHARMACY QUEEN ELIZABETH HOSPITAL, SHERIFF HILL, GATESHEAD, UNITED KINGDOM, NE9 6SX

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) RADIOPHARMACEUTICALS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

OTHER PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES RADIOPHARMACEUTICALS/RADIONUCLIDE GENERATORS

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) OTHER ASEPTICALLY PREPARED PRODUCTS RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

SITE ID : 30186 CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST - SUNDERLAND RADIOPHARMACY SUNDERLAND ROYAL HOSPITAL, KAYLL ROAD, SUNDERLAND, UNITED KINGDOM, SR4 7TP

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE

NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER NON-STERILE MEDICINAL PRODUCTS RADIOPHARMACEUTICALS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING RADIONUCLIDE GENERATORS

OTHER PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES RADIOPHARMACEUTICALS/RADIONUCLIDE GENERATORS

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

SITE ID : 91004 CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST - SOUTH TYNESIDE RADIOPHARMACY HARTON LANE, SOUTH TYNESIDE DISTRICT HOSPITAL, SOUTH SHIELDS, UNITED KINGDOM, NE34 0PL

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE

NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER NON-STERILE MEDICINAL PRODUCTS RADIOPHARMACEUTICALS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

OTHER PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES RADIOPHARMACEUTICALS/RADIONUCLIDE GENERATORS

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 34 of 147 SITE ID : 511458 CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST SUNDERLAND HOSPITAL, KAYLL ROAD, SUNDERLAND, UNITED KINGDOM, SR4 7TP

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING TABLETS

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS PENICILLIN'S AND CEPHALOSPORIN'S USED IN ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) CENTRALISED INTRAVENOUS ADDITIVE SERVICE ONLY, USING CLOSED SYSTEMS AND LICENSED STARTING MATERIALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 18612

CLATTERBRIDGE CENTRE FOR ONCOLOGY CLATTERBRIDGE ROAD, BEBINGTON, WIRRAL, UNITED KINGDOM, CH63 4JY

SITE ID : 11105 CLATTERBRIDGE CENTRE FOR ONCOLOGY CLATTERBRIDGE ROAD, BEBINGTON, WIRRAL, UNITED KINGDOM, CH63 4JY

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE PRIMARY PACKAGING SEMI-SOLIDS

Licence Holder MS 20929

CLINIGEN CTS LIMITED PITCAIRN HOUSE, CROWN SQUARE, FIRST AVENUE, BURTON-ON-TRENT, UNITED KINGDOM, DE14 2WW

SITE ID : 4487301 CLINIGEN HEALTHCARE LIMITED UNIT 2, BRUNEL DRIVE, STRETTON, BURTON-ON-TRENT, UNITED KINGDOM, DE13 0BY

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 35 of 147 Licence Holder MS 31644

CLINIGEN HEALTHCARE LIMITED PITCAIRN HOUSE, CROWN SQUARE, FIRST AVENUE, BURTON-ON-TRENT, UNITED KINGDOM, DE14 2WW

SITE ID : 91930 KEATS HEALTHCARE LIMITED PITCAIRN HOUSE, CROWN SQUARE, FIRST AVENUE, BURTON-ON-TRENT, UNITED KINGDOM, DE14 2WW

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 4487301 CLINIGEN HEALTHCARE LIMITED UNIT 2, BRUNEL DRIVE, STRETTON, BURTON-ON-TRENT, UNITED KINGDOM, DE13 0BY

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 36 of 147 Licence Holder MS 12882

COLCHESTER HOSPITAL UNIVERSITY NHS FOUNDATION TRUST TURNER ROAD, TRUST HEADQUARTERS, COLCHESTER GENERAL HOSPITAL, COLCHESTER, ESSEX, UNITED KINGDOM, CO4 5JL

SITE ID : 14230 COLCHESTER GENERAL HOSPITAL.

PHARMACY DEPT, TURNER ROAD, COLCHESTER, UNITED KINGDOM, CO4 5JL

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS MONOCLONAL ANTIBODIES

NON-STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGIMPREGNATED DOSAGE FORMS)MATRICES NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING IMPREGNATED MATRICES PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

PRIMARY PACKAGING OTHER NON-STERILE MEDICINAL PRODUCTS POWDERS FOR ORAL USE PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

OTHER SECTION 10 (EXTEMPORANEOUS PREPARATION); REGULATION 37 EXEMPEION IMP ASSEMBLY; BLOOD LABELLING; PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES VERTERINARY EXTEMPORANEOUS PRESCRIPTIONS RADIOPHARMACY PREPARATION RADIOPHARMACEUTICALS/RADIONUCLIDE OTHER MANUFACTURING/IMPORT ACTIVITIES GENERATORS OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER TERMINALLY STERILISED PREPARED TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGPRODUCTS DOSAGE PARAFFIN FORMS) IMPREGNATED GAUZE (STERILISED BY IRRADIATION AT SYNERGY HEALTH LTD)

SITE ID : 17744 SYNERGY HEALTH STERILISATION UK LIMITED BRUNEL CLOSE, DRAYTON FIELDS INDUSTRIAL ESTATE, DAVENTRY, UNITED KINGDOM, NN11 8RB

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGGAMMA DOSAGE IRRADICATION FORMS) OF THROAT PACKS MADE BY COLCHESTER HOSPITAL

Date of Publication 01 August 2015 Human Only Page 37 of 147 Licence Holder MS 13606

CO-PHARMA LIMITED UNIT 4, METRO CENTRE, TOLPITS LANE, WATFORD, UNITED KINGDOM, WD18 9SS

SITE ID : 6963 ALLOGA UK LIMITED AMBER PARK 1, 2, AND 3, BERRISTOW LANE, SOUTH NORMANTON, ALFRETON, UNITED KINGDOM, DE55 2FH

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 10410

CORPUS NOSTRUM LIMITED UNIT 1, CARDINAL WEST, CARDINAL PARK, CARDINAL WAY, GODMANCHESTER, HUNTINGDON, UNITED KINGDOM, PE29 2XN

SITE ID : 56091 MANDEVILLE MEDICINES

STOKE MANDEVILLE HOSPITAL, MANDEVILLE ROAD, AYLESBURY, UNITED KINGDOM, HP21 8AL

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SUPPOSITORIES SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS SUPPOSITORIES UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING TABLETS

STERILE PRODUCTS TERMINALLY STERILISED LARGE VOLUME LIQUIDS TERMINALLY STERILISED SMALL VOLUME LIQUIDS

Licence Holder MS 21394

COUNTESS OF CHESTER HOSPITAL NHS FOUNDATION TRUST LIVERPOOL ROAD, MARTINDALE HOUSE, CHESTER, UNITED KINGDOM, CH2 1BQ

SITE ID : 19477 PHARMACY STERILE & ASEPTIC SERVICES MARTINDALE HOUSE, LIVERPOOL ROAD, CHESTER, UNITED KINGDOM, CH2 1BQ

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS TERMINALLY STERILISED SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 38 of 147 Licence Holder MS 4543

CP PHARMACEUTICALS LIMITED ASH ROAD, WREXHAM INDUSTRIAL ESTATE, WREXHAM, UNITED KINGDOM, LL13 9UF

SITE ID : 15498 CP PHARMACEUTICALS LIMITED ASH ROAD NORTH, WREXHAM, UNITED KINGDOM, LL13 9UF

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS MANUFACTURE OF PRODUCTS BASED ON BOTANICAL EXTRACTS AND HORMONES.

OTHER NON-STERILE MEDICINAL PRODUCTS PACKAGING ONLY PRIMARY PACKAGING NASAL SPRAY

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLYOPHILISATES DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 31862

CREO PHARMA LIMITED FELSTED BUSINESS CENTRE, COCK GREEN, FELSTED, DUNMOW, UNITED KINGDOM, CM6 3LY

SITE ID : 92402 PHARMADEX LOGISTICS LIMITED

TRAVELLERS LANE, WELHAM GREEN, HATFIELD, UNITED KINGDOM, AL9 7HF

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 231

CSL BEHRING UK LIMITED HAYWORTH HOUSE, MARKET PLACE, HAYWARDS HEATH, UNITED KINGDOM, RH16 1DB

SITE ID : 23599 CSL BEHRING UK LIMITED HAYWORTH HOUSE, MARKET PLACE, HAYWARDS HEATH, UNITED KINGDOM, RH16 1DB

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 39 of 147 Licence Holder MS 4102

CUSTOM PHARMACEUTICALS LIMITED CONWAY STREET, HOVE, UNITED KINGDOM, BN3 3LW

SITE ID : 15213 CUSTOM PHARMACEUTICALS LIMITED CONWAY STREET, HOVE, UNITED KINGDOM, BN3 3LW

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

SITE ID : 92262 CUSTOM PHARMACEUTICALS LIMITED UNIT 2, FAIRWAY TRADING ESTATE, MOULSECOOMB WAY, BRIGHTON, UNITED KINGDOM, BN2 4PB

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT

Licence Holder MS 123

DALES PHARMACEUTICALS LIMITED SNAYGILL INDUSTRIAL ESTATE, KEIGHLEY ROAD, SKIPTON, UNITED KINGDOM, BD23 2RW

SITE ID : 2904 DALES PHARMACEUTICALS LIMITED SNAYGILL INDUSTRIAL ESTATE, KEIGHLEY ROAD, SKIPTON, UNITED KINGDOM, BD23 2RW

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 40 of 147 Licence Holder MS 17854

DERBY TEACHING HOSPITALS NHS FOUNDATION TRUST RADIOPHARMACY UNIT, UTTOXETER ROAD, DERBY, UNITED KINGDOM, DE22 3NE

SITE ID : 10032 ROYAL DERBY HOSPITAL NUCLEAR MEDICINE ROYAL DERBY HOSPITAL, UTTOXETER ROAD, DERBY, UNITED KINGDOM, DE22 3HE

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGRADIOACTIVE DOSAGE MATERIALS FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 603102 DERBY HOSPITALS NHS FOUNDATION TRUST DEPARTMENT OF PHARMACY, ROYAL DERBY HOSPITAL, UTTOXETER ROAD, DERBY, UNITED KINGDOM, DE22 3NE

RADIOPHARMACEUTICALS/RADIONUCLIDE PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES GENERATORS

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 22874

DERBY TEACHING HOSPITALS NHS FOUNDATION TRUST DEPARTMENT OF PHARMACY, ROYAL DERBY HOSPITAL, UTTOXETER ROAD, DERBY, UNITED KINGDOM, DE22 3NE

SITE ID : 603102 ROYAL DERBY HOSPITAL DEPARTMENT OF PHARMACY, ROYAL DERBY HOSPITAL, UTTOXETER ROAD, DERBY, UNITED KINGDOM, DE22 3NE

Licence Holder MS 27376

DIAGNOSTIC IMAGING LIMITED ELKINGTON LODGE, WELFORD, UNITED KINGDOM, NN6 6HE

SITE ID : 112965 DIAGNOSTIC IMAGING LIMITED

ELKINGTON LODGE, WELFORD, UNITED KINGDOM, NN6 6HE

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 41 of 147 Licence Holder MS 25568

DONCASTER AND BASSETLAW HOSPITALS NHS FOUNDATION TRUST ARMTHORPE ROAD, DONCASTER ROYAL INFIRMARY, DONCASTER, UNITED KINGDOM, DN2 5LT

SITE ID : 88609 DONCASTER ROYAL INFIRMARY ARMTHORPE ROAD, DONCASTER ROYAL INFIRMARY, DONCASTER, UNITED KINGDOM, DN2 5LT

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 8553

DR REDDY'S LABORATORIES (UK) LIMITED 6 RIVERVIEW ROAD, BEVERLEY, UNITED KINGDOM, HU17 0LD

SITE ID : 18014 DR REDDY'S LABORATORIES (UK) LIMITED 6 RIVERVIEW ROAD, BEVERLEY, UNITED KINGDOM, HU17 0LD

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS

PACKAGING ONLY PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY OF PARALLEL IMPORTED PRODUCTS OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Licence Holder MS 3537

DR S B KAYNE BUSBY PHARMACY, 20 MAIN STREET, CLARKSTON, GLASGOW, UNITED KINGDOM, G76 8DU

SITE ID : 92159 FREEMAN'S HOMEOPATHIC PHARMACY BUSBY PHARMACY, 20 MAIN STREET, CLARKSTON, GLASGOW, UNITED KINGDOM, G76 8DU

OTHER NON-STERILE MEDICINAL PRODUCTS HOMEOPATHIC ORAL & TOPICAL REMEDIES. UNIT AND MULTI-DOSE NON-STERILE LIQUIDS NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) FOR INTERNAL AND EXTERNAL USE; CREAMS, OINTMENTS, LOTIONS, TABLETS, PILLS, GRANULES, UNIT AND BULK POWDERS (ALL SURFACE INNOCULATED)

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS

Date of Publication 01 August 2015 Human Only Page 42 of 147 Licence Holder MS 20912

DRUGSRUS LIMITED 5 SANDRIDGE CLOSE, HARROW, UNITED KINGDOM, HA1 1XD

SITE ID : 89220 DRUGSRUS LIMITED 5 SANDRIDGE CLOSE, HARROW, UNITED KINGDOM, HA1 1XD

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 4321

DURBIN PLC 180 NORTHOLT ROAD, HARROW, UNITED KINGDOM, HA2 0LT

SITE ID : 31307 DURBIN PLC 180 NORTHOLT ROAD, HARROW, UNITED KINGDOM, HA2 0LT

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS OTHER PHARMACEUTICALS WITH MHRA OTHER MANUFACTURING/IMPORT ACTIVITIES NOTIFICATION AND PERMISSION UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 92333 DURBIN PLC 19 FAIRWAY DRIVE, GREENFORD, UNITED KINGDOM, UB6 8PW

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS

OTHER MANUFACTURING/IMPORT ACTIVITIES OTHER PHARMACEUTICALS WITH MHRA NOTIFICATION AND PERMISSION UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 936068 DURBIN PLC 12 FAIRWAY DRIVE, GREENFORD, UNITED KINGDOM, UB6 8PW

Date of Publication 01 August 2015 Human Only Page 43 of 147 Licence Holder MS 31057

EAST AND NORTH HERTFORDSHIRE NHS TRUST PHARMACY DEPT, LISTER HOSPITAL, EAST AND NORTH HERTS NHS TRUST, STEVENAGE, UNITED KINGDOM, SG1 4AB

SITE ID : 5000 QUALITY CONTROL DEPARTMENT, THE LISTER HOSPITAL

COREYS MILL LANE, STEVENAGE, UNITED KINGDOM, SG1 4AB

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS STERILITY TESTING TRACE ELEMENT ANALYSIS

SITE ID : 10834 LISTER HOSPITAL PHARMACY DEPT, LISTER HOSPITAL, EAST AND NORTH HERTS NHS TRUST, STEVENAGE, UNITED KINGDOM, SG1 4AB

Licence Holder MS 12690

EAST CHESHIRE NHS TRUST MACCLESFIELD DISTRICT GENERAL HOSPITAL, PHARMACY REPACKAGING UNIT, MACCLESFIELD, UNITED KINGDOM, SK10 3BL

SITE ID : 22188 PHARMACY REPACKAGING UNIT MACCLESFIELD DISTRICT GENERAL HOSPITAL, MACCLESFIELD, UNITED KINGDOM, SK10 3BL

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING TABLETS

Date of Publication 01 August 2015 Human Only Page 44 of 147 Licence Holder MS 18763

EAST KENT HOSPITALS UNIVERSITY NHS FOUNDATION TRUST KENT & CANTERBURY HOSPITAL PHARMACY(RADIOPHARMACY), ETHELBURT ROAD, CANTERBURY, UNITED KINGDOM, CT1 3NG

SITE ID : 30229 KENT AND CANTERBURY HOSPITAL

ETHELBERT ROAD, CANTERBURY, UNITED KINGDOM, CT1 3NG

OTHER NON-STERILE MEDICINAL PRODUCTS IODINE - 131 AS AN ORAL LIQUID FOR PATIENTS NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGWHO CAN¿TDOSAGE TAKE FORMS) CAPSULES RADIOACTIVE TEST MEALS.

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS

ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ASEPTICALLY FORMS) PREPARED PRODUCTS RADIOPHARMACEUTICAL INJECTIONS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 32967

EASTSTONE LIMITED UNIT 1, BARRS FOLD ROAD, WINGATES INDUSTRIAL ESTATE, WESTHOUGHTON, BOLTON, UNITED KINGDOM, BL5 3XP

SITE ID : 1826166 EASTSTONE LIMITED UNIT 1, BARRS FOLD ROAD, WINGATES INDUSTRIAL ESTATE, WESTHOUGHTON, BOLTON, UNITED KINGDOM, BL5 3XP

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE SOFT FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING TRANSDERMAL PATCHES

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY OF PARALLEL IMPORTED PRODUCTS OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 45 of 147 Licence Holder MS 40918

EAST SUSSEX HEALTHCARE NHS TRUST KINGS DRIVE, EASTBOURNE, UNITED KINGDOM, BN21 2UD

SITE ID : 27965 EASTBOURNE PHARMACEUTICALS KINGS DRIVE, EASTBOURNE, UNITED KINGDOM, BN21 2UD

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS

Licence Holder MS 42117

EMCURE PHARMA UK LIMITED 1 DOUGHTY STREET, LONDON, UNITED KINGDOM, WC1N 2PH

SITE ID : 9152145 EMCURE PHARMA UK LIMITED DEVONSHIRE HOUSE, 582 HONEYPOT LANE, STANMORE, UNITED KINGDOM, HA7 1JS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 40739

ENNOGEN HEALTHCARE LIMITED UNIT G4, RIVERSIDE INDUSTRIAL ESTATE, RIVERSIDE WAY, DARTFORD, UNITED KINGDOM, DA1 5BS

SITE ID : 22318 PHARMPACT LIMITED - DARTFORD UNIT G4, RIVERSIDE INDUSTRIAL ESTATE, RIVERSIDE WAY, DARTFORD, UNITED KINGDOM, DA1 5BS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 46 of 147 Licence Holder MS 16133

ESSENTIAL NUTRITION LIMITED BANK HOUSE, SALTGROUNDS ROAD, BROUGH, UNITED KINGDOM, HU15 1EG

SITE ID : 31039 ESSENTIAL NUTRITION LIMITED ESSENTIAL NUTRITION LIMITED, BANK HOUSE, SALTGROUNDS ROAD, BROUGH, UNITED KINGDOM, HU15 1EG

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCYTOTOXICS/HORMONES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER BULK PRODUCTS FOR PACKING OTHER MANUFACTURING/IMPORT ACTIVITIES ELSEWHERE OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Licence Holder MS 43542

EURO-LINK PHARMA LIMITED 110 BUTTERFIELD, GREAT MARLINGS, LUTON, UNITED KINGDOM, LU2 8DL

SITE ID : 12302391 EURO-LINK PHARMA LIMITED

110 BUTTERFIELD, GREAT MARLINGS, LUTON, UNITED KINGDOM, LU2 8DL

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 19441

EUROPEAN NUTRIPHARM LIMITED THE OLD BREWERY HOUSE, TWYFORD, WINCHESTER, UNITED KINGDOM, SO21 1RG

SITE ID : 588788 EUROPEAN NUTRIPHARM LIMITED THE OLD BREWERY, HIGH STREET, TWYFORD, UNITED KINGDOM, SO21 1RG

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 47 of 147 Licence Holder MS 20685

FERNDALE PHARMACEUTICALS LIMITED UNIT 740, STREET 2, THORP ARCH ESTATE, WETHERBY, UNITED KINGDOM, LS23 7FX

SITE ID : 7793512 FERNDALE PHARMACEUTICALS LIMITED UNIT 740, STREET 2, THORP ARCH ESTATE, WETHERBY, UNITED KINGDOM, LS23 7FX

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 18693

FISHER CLINICAL SERVICES UK LIMITED LANGHURSTWOOD ROAD, HORSHAM, UNITED KINGDOM, RH12 4QD

SITE ID : 11204 FISHER CLINICAL SERVICES UK LIMITED LANGHURSTWOOD ROAD, HORSHAM, UNITED KINGDOM, RH12 4QD

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING TABLETS PRIMARY PACKAGING TRANSDERMAL PATCHES

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY OF PARALLEL IMPORTED PRODUCTS UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 48 of 147 Licence Holder MS 4394

FLEET LABORATORIES LIMITED 94 RICKMANSWORTH ROAD, WATFORD, UNITED KINGDOM, WD18 7JJ

SITE ID : 3787 FLEET LABORATORIES LIMITED 94 RICKMANSWORTH ROAD, WATFORD, UNITED KINGDOM, WD18 7JJ

Licence Holder MS 17891

FLYNN PHARMA LIMITED C/O HERTLANDS HOUSE, PRIMETT ROAD, STEVENAGE, UNITED KINGDOM, SG1 3EE

SITE ID : 6963 ALLOGA UK LIMITED AMBER PARK 1, 2, AND 3, BERRISTOW LANE, SOUTH NORMANTON, ALFRETON, UNITED KINGDOM, DE55 2FH

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 49 of 147 Licence Holder MS 5928

FORUM PRODUCTS LIMITED CROWN HOUSE, 2-8 GLOUCESTER ROAD, REDHILL, UNITED KINGDOM, RH1 1FH

SITE ID : 14887 BIMEDA UK LTD UNIT 2, BRYN CEFNI, LLANGEFNI, UNITED KINGDOM, LL77 7XA

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 10565625 FORUM PRODUCTS LIMITED CROWN HOUSE, 2-8 GLOUCESTER ROAD, REDHILL, UNITED KINGDOM, RH1 1FH

NON-STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS NON-STERILE PRODUCTS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS TERMINALLY STERILISED PRODUCTS

Licence Holder MS 11916

FRIMLEY PARK HOSPITAL NHS FOUNDATION TRUST HOLDER ROAD, UNIT D, MANAWEY BUSINESS PARK, ALDERSHOT, UNITED KINGDOM, GU12 4RH

SITE ID : 89578 FARNHAM PHARMACEUTICAL REPACKAGING UNIT HOLDER ROAD, UNIT D, MANAWEY BUSINESS PARK, ALDERSHOT, UNITED KINGDOM, GU12 4RH

Date of Publication 01 August 2015 Human Only Page 50 of 147 Licence Holder MS 28265

GATESHEAD HEALTH NHS FOUNDATION TRUST QUEEN ELIZABETH HOSPITAL, SHERIFF HILL, GATESHEAD, UNITED KINGDOM, NE9 6SX

SITE ID : 10677 CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST - GATESHEAD RADIOPHARMACY QUEEN ELIZABETH HOSPITAL, SHERIFF HILL, GATESHEAD, UNITED KINGDOM, NE9 6SX

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 221

GE HEALTHCARE LIMITED AMERSHAM PLACE, LITTLE CHALFONT, UNITED KINGDOM, HP7 9NA

SITE ID : 14432 GE HEALTHCARE LIMITED

THE GROVE CENTRE, WHITE LION ROAD, AMERSHAM, UNITED KINGDOM, HP7 9LL

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) MEDICINAL GASES SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS MEDICINAL GASES

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS OTHER TERMINALLY STERILISED PREPARED PRODUCTS SMALL VOLUME LIQUIDS - REACTOR PRODUCED RADIOPHARMACEUTICALS; CYCLOTRON PRODUCED TERMINALLY STERILISED RADIOPHARMACEUTICALS AND POSITRON EMITTING TOMOGRAPHY (PET) RADIOPHARMACEUTICALS WITH HALF LIFE OF LESS THAN TWO HOURS TERMINALLY STERILISED SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 51 of 147 Licence Holder MS 8596

GENZYME LIMITED 37 HOLLANDS ROAD, HAVERHILL, UNITED KINGDOM, CB9 8PU

SITE ID : 18052 GENZYME LIMITED 37 HOLLANDS ROAD, HAVERHILL, UNITED KINGDOM, CB9 8PU

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 15989

GEORGE ELIOT HOSPITAL NHS TRUST PHARMACY DEPT., GEORGE ELIOT HOSPITAL, COLLEGE STREET, NUNEATON, UNITED KINGDOM, CV10 7DJ

SITE ID : 7395 GEORGE ELIOT HOSPITAL NHS TRUST PHARMACY DEPT., GEORGE ELIOT HOSPITAL, COLLEGE STREET, NUNEATON, UNITED KINGDOM, CV10 7DJ

Licence Holder MS 42551

GERYON PHARMA LIMITED 18 OWEN DRIVE, LIVERPOOL, UNITED KINGDOM, L24 1YL

SITE ID : 9284660 GREYON PHARMA LIMITED 18 OWEN DRIVE, LIVERPOOL, UNITED KINGDOM, L24 1YL

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 52 of 147 Licence Holder MS 4

GLAXO OPERATIONS UK LIMITED 980 GREAT WEST ROAD, BRENTFORD, UNITED KINGDOM, TW8 9GS

SITE ID : 3848 GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS HARMIRE ROAD, BARNARD CASTLE, UNITED KINGDOM, DL12 8DT

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLICENSABLE DOSAGE MEDICINAL FORMS) DEVICES NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

SITE ID : 15159 GLAXO OPERATIONS UK LIMITED PRIORY STREET, WARE, UNITED KINGDOM, SG12 0DJ

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS STEROIDS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE SOFT FORMS) SHELL OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLICENSABLE DOSAGE MEDICINAL FORMS) DEVICES AND STEROIDS. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 53 of 147 Licence Holder MS 5866

GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED 980 GREAT WEST ROAD, BRENTFORD, UNITED KINGDOM, TW8 9GS

SITE ID : 21295 GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED NEW FRONTIERS SCIENCE PARK SOUTH, THIRD AVENUE, HARLOW, UNITED KINGDOM, CM19 5AW

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL OTHER NON-STERILE MEDICINAL PRODUCTS PACKAGING OF FILLED PRIMARY CONTAINERS, PRIMARY PACKAGING INCLUDING VIALS AND AMPOULES, INTO CARTONS.

SITE ID : 27277 GLAXOSMITHKLINE RESEARCH & DEVELOPMENT PARK ROAD, WARE, UNITED KINGDOM, SG12 0DP

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS SOLID NON-STERILE MULTI DOSE FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWING(INCLUDING DOSAGE POWDERS FORMS) AND GRANULES), POWDER INHALATION PRODUCTS AND DEVICES. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 54 of 147 Licence Holder MS 19584

GLOUCESTERSHIRE HOSPITALS NHS FOUNDATION TRUST 1 COLLEGE LAWN, CHELTENHAM, UNITED KINGDOM, GL53 7AG

SITE ID : 28720 PHARMACY, CHELTENHAM GENERAL HOSPITAL SANDFORD ROAD, CHELTENHAM, UNITED KINGDOM, GL53 7AN

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING TABLETS

SITE ID : 90698 PHARMACY DEPARTMENT GREAT WESTERN ROAD, GLOUCESTERSHIRE ROYAL HOSPITAL NHS TRUST, GLOUCESTER, UNITED KINGDOM, GL1 3NN

OTHER NON-STERILE MEDICINAL PRODUCTS PACKAGING ONLY PRIMARY PACKAGING AEROSOLS, OINTMENTS, CREAMS

Date of Publication 01 August 2015 Human Only Page 55 of 147 Licence Holder MS 17328

GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS TRUST, GREAT ORMOND STREET, LONDON, UNITED KINGDOM, WC1N 3JH

SITE ID : 9306 GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS TRUST

PHARMACY DEPT, GREAT ORMOND STREET, LONDON, UNITED KINGDOM, WC1N 3JH

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS ENZYME REPLACEMENT THERAPIES

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS

ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ASEPTICALLY FORMS) PREPARED PRODUCTS TOTAL PARENTERAL NUTRITION ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 2091287 GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS TRUST CELLULAR THERAPIES, GREAT ORMOND STREET, LONDON, UNITED KINGDOM, WC1N 3JH

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS GENE THERAPY PRODUCTS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 56 of 147 Licence Holder MS 11387

GUY'S AND ST THOMAS' NHS FOUNDATION TRUST PHARMACY MANUFACTURING UNIT, 13TH FLOOR, GUY'S TOWER, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, UNITED KINGDOM, SE1 9RT

SITE ID : 27444 GUY'S AND ST THOMAS' NHS FOUNDATION TRUST

PHARMACY PRODUCTION UNIT, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, UNITED KINGDOM, SE1 9RT

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CYTOTOXICS, CYSTOSTATICS AND ANTIBIOTICS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGDRESSINGS, DOSAGE SOLID FORMS) NON-STERILE MULTI DOSE FORMS (INCLUDING POWDERS AND GRANULES NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGCYTOTOXICS, DOSAGE CYSTOSTATICS, FORMS) ANTIBIOTICS. ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER TERMINALLY STERILISED PREPARED TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGPRODUCTS DOSAGE DRESSING FORMS) TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 31430 CLINICAL PET CENTRE ST THOMAS HOSPITAL, WESTMINSTER BRIDGE ROAD, LONDON, UNITED KINGDOM, SE1 7EH

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS RADIOPHARMACEUTICAL CYCLOTRON PRODUCED PET AGENTS

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGRADIOPHARMACEUTICALS DOSAGE FORMS) CYCLOTRON PRODUCED PET AGENTS. ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 351560 RADIOPHARMACY UNIT RADIOPHARMACY UNIT, NUCLEAR MEDICINE, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, UNITED KINGDOM, SE1 9RT

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS RADIOPHARMACEUTICALS.

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ASEPTICALLY FORMS) PREPARED PRODUCTS RADIOPHARMACEUTICALS. ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 6280106 GUY'S AND ST THOMAS' NHS FOUNDATION TRUST CLINICAL RESEARCH FACILITY, 15TH FLOOR, TOWER WING, GUY'S HOSPITAL, GREAT MAZE POND, LONDON, UNITED KINGDOM, SE1 9RT

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS GENE THERAPY PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS AUTOLOGOUS OR ALLOGENEIC CELL BIOLOGICAL MEDICINAL PRODUCTS THERAPIES FOR INTRAVENOUS OR SOLID TISSUE

Date of Publication 01 August 2015 Human Only Page 57 of 147 Licence Holder MS 18024

GW PHARMA LIMITED SOVEREIGN HOUSE, VISION PARK, CHIVERS WAY, HISTON, CAMBRIDGE, UNITED KINGDOM, CB24 9BZ

SITE ID : 5680 MOVIANTO UK LIMITED 1A PROGRESS PARK, ELSTOW, BEDFORD, UNITED KINGDOM, MK42 9XE

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 93802 IDIS LIMITED IDIS HOUSE, CHURCHFIELD ROAD, WEYBRIDGE, UNITED KINGDOM, KT13 8DB

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 15140

HAMMERSMITH MEDICINES RESEARCH LIMITED CUMBERLAND AVENUE, LONDON, UNITED KINGDOM, NW10 7EW

SITE ID : 671693 HAMMERSMITH MEDICINES RESEARCH LIMITED CUMBERLAND AVENUE, LONDON, UNITED KINGDOM, NW10 7EW

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

Licence Holder MS 17249

HARROGATE AND DISTRICT NHS FOUNDATION TRUST TRUST HEADQUARTERS, THE STRAYSIDE WING, HARROGATE DISTRICT HOSPITAL, LANCASTER PARK ROAD, HARROGATE, UNITED KINGDOM, HG2 7SX

SITE ID : 9195 HARROGATE HEALTH CARE NHS TRUST TRUST HEADQUARTERS, THE STRAYSIDE WING, HARROGATE DISTRICT HOSPITAL, LANCASTER PARK ROAD, HARROGATE, UNITED KINGDOM, HG2 7SX

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 58 of 147 Licence Holder MS 35531

HEALTHXCHANGE PHARMACY UK LIMITED 79 GREAT PORTLAND STREET, LONDON, UNITED KINGDOM, W1W 7LS

SITE ID : 1031409 HEALTHXCHANGE PHARMACY UK LIMITED 79 GREAT PORTLAND STREET, LONDON, UNITED KINGDOM, W1W 7LS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 27776

HELIOS HOMOEOPATHY LIMITED 89-97 CAMDEN ROAD, TUNBRIDGE WELLS, UNITED KINGDOM, TN1 2QR

SITE ID : 5569 HELIOS HOMOEOPATHY LIMITED 89-97 CAMDEN ROAD, TUNBRIDGE WELLS, UNITED KINGDOM, TN1 2QR

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS TABLETS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE PRIMARY PACKAGING OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 59 of 147 Licence Holder MS 14689

HIGHER NATURE LIMITED THE NUTRITION CENTRE, BURWASH COMMON, ETCHINGHAM, UNITED KINGDOM, TN19 7LX

SITE ID : 5472 HIGHER NATURE LIMITED THE NUTRITION CENTRE, BURWASH COMMON, ETCHINGHAM, UNITED KINGDOM, TN19 7LX

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 11522

HILLINGDON HOSPITAL NHS TRUST PHARMACY DEPARTMENT, PIELD HEATH ROAD, UXBRIDGE, UNITED KINGDOM, UB8 3NN

SITE ID : 90063 THE HILLINGDON HOSPITAL NHS TRUST PHARMACY DEPARTMENT, HILLINGDON HOSPITAL, PIELD HEATH ROAD, UXBRIDGE, UNITED KINGDOM, UB8 3NN

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

Licence Holder MS 4515

HOSPIRA UK LIMITED UNITS 732-733, TUDOR ESTATE, ABBEY ROAD, PARK ROYAL, LONDON, UNITED KINGDOM, NW10 7UN

SITE ID : 2145626 HOSPIRA UK LIMITED UNITS 732-733, TUDOR ESTATE, ABBEY ROAD, PARK ROYAL, LONDON, UNITED KINGDOM, NW10 7UN

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 2776270 HOSPIRA UK LIMITED UNIT 1, STAFFORD CROSS BUSINESS PARK, STAFFORD ROAD, CROYDON, UNITED KINGDOM, CR0 4TU

Date of Publication 01 August 2015 Human Only Page 60 of 147 Licence Holder MS 8733

IDIS LIMITED IDIS HOUSE, CHURCHFIELD ROAD, WEYBRIDGE, UNITED KINGDOM, KT13 8DB

SITE ID : 93802 IDIS LIMITED IDIS HOUSE, CHURCHFIELD ROAD, WEYBRIDGE, UNITED KINGDOM, KT13 8DB

NON-STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS NON-STERILE PRODUCTS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES MEDICINAL GASES UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS TERMINALLY STERILISED PRODUCTS

SITE ID : 362376 IDIS LIMITED UNIT 3, CANADA ROAD, BYFLEET, WEST BYFLEET, UNITED KINGDOM, KT14 7JL

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 35903

IMAGING EQUIPMENT LIMITED THE BARN, MANOR FARM, CHURCH LANE, CHILCOMPTON, RADSTOCK, UNITED KINGDOM, BA3 4HP

SITE ID : 2636803 IMAGING EQUIPMENT LIMITED THE BARN, MANOR FARM, CHURCH LANE, CHILCOMPTON, RADSTOCK, UNITED KINGDOM, BA3 4HP

RADIOPHARMACEUTICALS/RADIONUCLIDE PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES GENERATORS UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 61 of 147 Licence Holder MS 40081

IMANOVA LIMITED BURLINGTON DANES BUILDING, HAMMERSMITH HOSPITAL, DU CANE ROAD, LONDON, UNITED KINGDOM, W12 0NN

SITE ID : 4000415 IMANOVA LIMITED

BURLINGTON DANES BUILDING, HAMMERSMITH HOSPITAL, DU CANE ROAD, LONDON, UNITED KINGDOM, W12 0NN

OTHER BIOLOGICAL MEDICINAL PRODUCTS PET BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS RADIOTRACERS

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) OTHER ASEPTICALLY PREPARED PRODUCTS PET RADIOTRACERS

Licence Holder MS 32611

IMPERIAL COLLEGE HEALTHCARE NHS TRUST PHARMACY DEPARTMENT, HAMMERSMITH HOSPITAL, DU CANE ROAD, LONDON, UNITED KINGDOM, W12 0HS

SITE ID : 27593 CHARING CROSS HOSPITAL, PHARMACY DEPARTMENT FULHAM PALACE ROAD, LONDON, UNITED KINGDOM, W6 8RF

SITE ID : 28745 HAMMERSMITH HOSPITALS NHS TRUST 150 DU CANE ROAD, LONDON, UNITED KINGDOM, W12 0NN

SITE ID : 105359 JOHN GOLDMAN CENTRE FOR CELLULAR THERAPY

HAMMERSMITH HOSPITAL, DU CANE ROAD, LONDON, UNITED KINGDOM, W12 0HS

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

Date of Publication 01 August 2015 Human Only Page 62 of 147 Licence Holder MS 19442

INTERCYTEX LIMITED THE CORE TECHNOLOGY FACILITY, 46 GRAFTON STREET, MANCHESTER, UNITED KINGDOM, M13 9NT

SITE ID : 2459992 UNIVERSITY OF MANCHESTER CLEANROOM FACILITY UNIT G27, GROUND FLOOR, CORE TECHNOLOGY FACILITY, 46 GRAFTON STREET, MANCHESTER, UNITED KINGDOM, M13 9NT

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ASEPTICALLY FORMS) PREPARED PRODUCTS DECELLULARISED HUMAN TISSUE ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 13269

IPSWICH HOSPITAL NHS TRUST HEATH ROAD, IPSWICH, UNITED KINGDOM, IP4 5PD

SITE ID : 29576 PHARMACY MANUFACTURING UNIT PHARMACY MANUFACTURING UNIT, HEATH ROAD, IPSWICH, UNITED KINGDOM, IP4 5PD

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL

PRIMARY PACKAGING OTHER NON-STERILE MEDICINAL PRODUCTS POWDER PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

Date of Publication 01 August 2015 Human Only Page 63 of 147 Licence Holder MS 33634

ITH PHARMA LIMITED UNIT 4, PREMIER PARK, PREMIER PARK ROAD, LONDON, UNITED KINGDOM, NW10 7NZ

SITE ID : 544699 ITH PHARMA LIMITED UNIT 4, PREMIER PARK, PREMIER PARK ROAD, LONDON, UNITED KINGDOM, NW10 7NZ

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 242

JANSSEN-CILAG LIMITED 50-100 HOLMERS FARM WAY, HIGH WYCOMBE, UNITED KINGDOM, HP12 4EG

SITE ID : 4858 MCGREGOR CORY LIMITED CHERWELL 1 & 2, MIDDLETON CLOSE, BANBURY, UNITED KINGDOM, OX16 4RS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 23473 JANSSEN-CILAG LIMITED 50-100 HOLMERS FARM WAY, HIGH WYCOMBE, UNITED KINGDOM, HP12 4EG

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 13315

JOHN BELL & CROYDEN LIMITED 50-54 WIGMORE STREET, LONDON, UNITED KINGDOM, W1U 2AU

SITE ID : 90536 JOHN BELL & CROYDEN LIMITED 50-54 WIGMORE STREET, LONDON, UNITED KINGDOM, W1U 2AU

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 64 of 147 Licence Holder MS 11

JOHN WYETH & BROTHER LIMITED HUNTERCOMBE LANE SOUTH, TAPLOW, MAIDENHEAD, UNITED KINGDOM, SL6 0PH

SITE ID : 4452 WYETH PHARMACEUTICALS NEW LANE, HAVANT, HAMPSHIRE, UNITED KINGDOM, PO9 2NG

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS: CYTOTOXICS

PACKAGING ONLY PRIMARY PACKAGING FILLING OF PRIMARY CONTAINERS PRIMARY PACKAGING LIQUID DOSAGE FORMS OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING BIOLOGICALS (ASSEMBLY ONLY)

PRIMARY PACKAGING SOLID DOSAGE FORMS (INCLUDES TABLETS AND POWDERS)

Licence Holder MS 18715

JOLINDA MEDICAL SUPPLIES LIMITED 27 OAKRIDGE AVENUE, RADLETT, UNITED KINGDOM, WD7 8EW

SITE ID : 91532 JOLINDA MEDICAL SUPPLIES LIMITED 27 OAKRIDGE AVENUE, RADLETT, UNITED KINGDOM, WD7 8EW

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS TERMINALLY STERILISED PRODUCTS

Date of Publication 01 August 2015 Human Only Page 65 of 147 Licence Holder MS 36456

JUNIPER PHARMA SERVICES LIMITED 8 ORCHARD PLACE, NOTTINGHAM BUSINESS PARK, NOTTINGHAM, UNITED KINGDOM, NG8 6PX

SITE ID : 1523938 JUNIPER PHARMA SERVICES LIMITED 8 ORCHARD PLACE, NOTTINGHAM BUSINESS PARK, NOTTINGHAM, UNITED KINGDOM, NG8 6PX

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING TABLETS

Licence Holder MS 21416

KINGS COLLEGE HOSPITAL NHS FOUNDATION TRUST KING'S COLLEGE HOSPITAL, DENMARK HILL, LONDON, UNITED KINGDOM, SE5 9RS

SITE ID : 21289 KINGS COLLEGE HOSPITAL NHS FOUNDATION TRUST (KING'S CELL ISOLATION UNIT) SITE B KING'S CELL ISOLATION UNIT, DENMARK HILL, LONDON, UNITED KINGDOM, SE5 9RS

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGALGINATE-ENCAPSULATED DOSAGE FORMS) HUMAN HEPATOCYTES (HEPATOCYTE MICROBEADS)

Date of Publication 01 August 2015 Human Only Page 66 of 147 Licence Holder MS 14523

KING'S COLLEGE LONDON DEPARTMENT OF HAEMATOLOGICAL AND EXPERIMENTAL MEDICINE, THE RAYNE INSTITUTE, 123 COLDHARBOUR LANE, LONDON, UNITED KINGDOM, SE5 9NU

SITE ID : 23497 RAYNE CELL THERAPY SUITE (RCTS) DEPARTMENT OF HAEMATOLOGICAL AND EXPERIMENTAL MEDICINE, THE RAYNE INSTITUTE, 123 COLDHARBOUR LANE, LONDON, UNITED KINGDOM, SE5 9NU

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 7467645 KING'S COLLEGE LONDON - KING'S CTU, NIHR-WELLCOME TRUST CLINICAL RESEARCH FACILITY KING'S CTU, NIHR-WELLCOME TRUST CLINICAL RESEARCH FACILITY, KING'S COLLEGE HOSPITAL, DENMARK HILL, LONDON, UNITED KINGDOM, SE5 9RS

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS GENE THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS ENCAPSULATED (ALGINATE) HUMAN CELLS BIOLOGICAL MEDICINAL PRODUCTS FROM DONATED HUMAN TISSUES SUCH AS HUMAN HEPATOCYTES

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES BIOLOGICAL ACTIVE STARTING MATERIALS

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ENCAPSULATED (ALGINATE) HUMAN CELLS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGFROM DOSAGE DONATED FORMS) HUMAN TISSUES SUCH AS HUMAN HEPATOCYTES ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS

Date of Publication 01 August 2015 Human Only Page 67 of 147 Licence Holder MS 34040

KOMTUR PHARMACEUTICALS UK LIMITED 4 HAMPTON HILL BUSINESS PARK, HIGH STREET, HAMPTON HILL, UNITED KINGDOM, TW12 1NP

SITE ID : 624622 KOMTUR PHARMACEUTICALS UK LIMITED 4 HAMPTON HILL BUSINESS PARK, HIGH STREET, HAMPTON HILL, UNITED KINGDOM, TW12 1NP

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 39352

KOSEI PHARMA UK LIMITED 956 BUCKINGHAM AVENUE, SLOUGH TRADING ESTATE, SLOUGH, UNITED KINGDOM, SL1 4NL

SITE ID : 7145925 KOSEI PHARMA UK LIMITED 956 BUCKINGHAM AVENUE, SLOUGH TRADING ESTATE, SLOUGH, UNITED KINGDOM, SL1 4NL

Licence Holder MS 3063

LALEHAM HEALTH AND BEAUTY LIMITED FAIRFIELD, BRADSHAW LANE, GREENHALGH, KIRKHAM, PRESTON, UNITED KINGDOM, PR4 3JA

SITE ID : 4327 LALEHAM HEALTH AND BEAUTY LIMITED FAIRFIELD, BRADSHAW LANE, GREENHALGH, KIRKHAM, PRESTON, UNITED KINGDOM, PR4 3JA

Date of Publication 01 August 2015 Human Only Page 68 of 147 Licence Holder MS 21327

LANCASHIRE TEACHING HOSPITALS NHS FOUNDATION TRUST ROYAL PRESTON HOSPITAL, SHAROE GREEN LANE, FULWOOD, PRESTON, UNITED KINGDOM, PR2 9HT

SITE ID : 21366 PRESTON PHARMACEUTICAL PRODUCTION UNIT ROYAL PRESTON HOSPITAL, SHAROE GREEN LANE, FULWOOD, PRESTON, UNITED KINGDOM, PR2 9HT

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS STEROIDS

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING RESUSCITATION KITS PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING TABLETS

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 18166

LEEDS TEACHING HOSPITALS NHS TRUST LEEDS GENERAL INFIRMARY, GREAT GEORGE STREET, LEEDS, UNITED KINGDOM, LS1 3EX

SITE ID : 107044 PHARMACEUTICAL STORE AND PHARMACY MANUFACTURING UNIT LEEDS TEACHING HOSPITALS PHARMACEUTICAL STORE, MOOR HOUSE, 125 MOOR ROAD, HUNSLET, LEEDS, UNITED KINGDOM, LS10 2JQ

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS MONOCLONAL ANTIBODIES, ANTI-TNF

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 69 of 147 Licence Holder MS 2391

L E WEST LIMITED THE I O CENTRE, 59-71 RIVER ROAD, BARKING, UNITED KINGDOM, IG11 0DR

SITE ID : 421758 L E WEST LIMITED THE I O CENTRE, 59-71 RIVER ROAD, BARKING, UNITED KINGDOM, IG11 0DR

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 15184

LEXON (UK) LIMITED UNIT 18, OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, UNITED KINGDOM, B98 0RE

SITE ID : 6246 LEXON (UK) LIMITED UNIT 18, OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, UNITED KINGDOM, B98 0RE

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGIMPREGNATED DOSAGE FORMS)MATRICES NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING CHEWING GUMS PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 70 of 147 Licence Holder MS 62906

LIVERPOOL HEART AND CHEST HOSPITAL NHS FOUNDATION TRUST PHARMACY DEPARTMENT, THOMAS DRIVE, LIVERPOOL, UNITED KINGDOM, L14 3PE

SITE ID : 89581 LIVERPOOL HEART AND CHEST HOSPITAL NHS FOUNDATION TRUST PHARMACY DEPARTMENT, THOMAS DRIVE, LIVERPOOL, UNITED KINGDOM, L14 3PE

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 44093

LONDON NORTH WEST HEALTHCARE NHS TRUST PHARMACY TECHNICAL SERVICES DEPARTMENT, NORTHWICK PARK HOSPITAL, WATFORD ROAD, HARROW, UNITED KINGDOM, HA1 3UJ

SITE ID : 3577 MEDICAL PHYSICS DEPARTMENT NORTHWICK PARK HOSPITAL WATFORD ROAD, HARROW, UNITED KINGDOM, HA1 3UJ

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS)

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGRADIOPHARMACEUTICALS. DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 19426 PHARMACY TECHNICAL SERVICES DEPARTMENT LONDON NORTH WEST HEALTHCARE NHS TRUST PHARMACY TECHNICAL SERVICES DEPARTMENT, NORTHWICK PARK HOSPITAL, WATFORD ROAD, HARROW, UNITED KINGDOM, HA1 3UJ

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 71 of 147 Licence Holder MS 41744

MALLINCKRODT UK COMMERCIAL LIMITED 5TH FLOOR, UNIVERSITY COLLEGE HOSPITAL, 235 EUSTON ROAD, LONDON, UNITED KINGDOM, NW1 2BU

SITE ID : 444563 MALLINCKRODT RADIOPHARMACY SERVICES 5TH FLOOR, UNIVERSITY COLLEGE HOSPITAL, 235 EUSTON ROAD, LONDON, UNITED KINGDOM, NW1 2BU

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGRADIOPHARMACEUTICALS DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS

Licence Holder MS 4077

M & A PHARMACHEM LIMITED WIGAN ROAD, WESTHOUGHTON, BOLTON, UNITED KINGDOM, BL5 2AL

SITE ID : 15191 M & A PHARMACHEM LIMITED

ALLENBY LABORATORIES, WIGAN ROAD, WESTHOUGHTON, BOLTON, UNITED KINGDOM, BL5 2AL

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

Date of Publication 01 August 2015 Human Only Page 72 of 147 Licence Holder MS 156

MARTINDALE PHARMACEUTICALS LIMITED BAMPTON ROAD, HAROLD HILL, ROMFORD, UNITED KINGDOM, RM3 8UG

SITE ID : 2700 MARTINDALE PHARMACEUTICALS BAMPTON ROAD, HAROLD HILL, ROMFORD, UNITED KINGDOM, RM3 8UG

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 6838 MARTINDALE PHARMACEUTICALS LIMITED HUBERT ROAD, BRENTWOOD, UNITED KINGDOM, CM14 4JY

Licence Holder MS 10640

MASTA LIMITED 11 ALBION STREET, 7TH FLOOR, CITY EXCHANGE, LEEDS, UNITED KINGDOM, LS1 5ES

SITE ID : 9326702 MASTA LIMITED 11 ALBION STREET, 7TH FLOOR, CITY EXCHANGE, LEEDS, UNITED KINGDOM, LS1 5ES

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 73 of 147 Licence Holder MS 32694

MATERIA MEDICA LIMITED MOUNT HOUSE, AIRTON, SKIPTON, UNITED KINGDOM, BD23 4BG

SITE ID : 1507167 MATERIA MEDICA LIMITED T\A MML PHARMA SERVICES MOUNT HOUSE, AIRTON, SKIPTON, UNITED KINGDOM, BD23 4BG

NON-STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS NON-STERILE PRODUCTS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS TERMINALLY STERILISED PRODUCTS

Licence Holder MS 741

MAWDSLEY-BROOKS & COMPANY LIMITED UNIT 3, SOUTH LANGWORTHY ROAD, PO BOX 18, SALFORD, UNITED KINGDOM, M50 2PW

SITE ID : 1686685 MAWDSLEY-BROOKS & COMPANY LIMITED UNIT 22, QUEST PARK, WHEATLEY HALL ROAD, DONCASTER, UNITED KINGDOM, DN2 4LT

SITE ID : 10487954 MAWDSLEY-BROOKS & COMPANY LIMITED INTERNATIONAL HOUSE, UNIT 4, HOUSTON PARK, SALFORD, UNITED KINGDOM, M50 2RP

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 14238

MCGREGOR CORY LIMITED MIDDLETON CLOSE, BANBURY, UNITED KINGDOM, OX16 4RS

SITE ID : 4858 MCGREGOR CORY LIMITED

CHERWELL 1 & 2, MIDDLETON CLOSE, BANBURY, UNITED KINGDOM, OX16 4RS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 74 of 147 Licence Holder MS 15142

MEDA PHARMACEUTICALS LIMITED CROCKFORD LANE, CEDARWOOD, CHINEHAM BUSINESS PARK, BASINGSTOKE, UNITED KINGDOM, RG24 8WD

SITE ID : 4858 MCGREGOR CORY LIMITED CHERWELL 1 & 2, MIDDLETON CLOSE, BANBURY, UNITED KINGDOM, OX16 4RS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 89345 MEDA PHARMACEUTICALS LIMITED CROCKFORD LANE, CEDARWOOD, CHINEHAM BUSINESS PARK, BASINGSTOKE, UNITED KINGDOM, RG24 8WD

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 13929

MEDICAL PHYSICS DEPT (NUCLEAR MEDICINE) MOUNT VERNON HOSPITAL MOUNT VERNON HOSPITAL, RICKMANSWORTH ROAD, NORTHWOOD, UNITED KINGDOM, HA6 2RN

SITE ID : 28343 MEDICAL PHYSICS DEPARTMENT (NUCLEAR MEDICINE) MOUNT VERNON HOSPITAL MOUNT VERNON HOSPITAL, RICKMANSWORTH ROAD, NORTHWOOD, UNITED KINGDOM, HA6 2RN

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 43870

MEDLEY PHARMA LIMITED UNIT 2A SEFTON BUSINESS PARK, AINTREE, LIVERPOOL, UNITED KINGDOM, L30 1RD

SITE ID : 3752075 MEDLEY PHARMA LIMITED UNIT 2A SEFTON BUSINESS PARK, AINTREE, LIVERPOOL, UNITED KINGDOM, L30 1RD

NON-STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS NON-STERILE PRODUCTS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 75 of 147 Licence Holder MS 20474

MEDWAY NHS FOUNDATION TRUST DEPARTMENT OF NUCLEAR MEDICINE, MEDWAY MARITIME HOSPITAL, GILLINGHAM, UNITED KINGDOM, ME7 5NY

SITE ID : 13545 MEDWAY NHS FOUNDATION TRUST, DEPARTMENT OF NUCLEAR MEDICINE

DEPARTMENT OF NUCLEAR MEDICINE, MEDWAY MARITIME HOSPITAL, GILLINGHAM, UNITED KINGDOM, ME7 5NY

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 25

MERCK SHARP & DOHME LIMITED HERTFORD ROAD, HODDESDON, UNITED KINGDOM, EN11 9BU

SITE ID : 14517 MERCK SHARP & DOHME LIMITED HERTFORD ROAD, HODDESDON, UNITED KINGDOM, EN11 9BU

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 12762

MERCURY PHARMACEUTICALS LIMITED CAPITAL HOUSE, 85 KING WILLIAM STREET, LONDON, UNITED KINGDOM, EC4N 7BL

SITE ID : 6963 ALLOGA UK LIMITED AMBER PARK 1, 2, AND 3, BERRISTOW LANE, SOUTH NORMANTON, ALFRETON, UNITED KINGDOM, DE55 2FH

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 76 of 147 Licence Holder MS 17545

MERIDIAN MEDICAL TECHNOLOGIES LIMITED FORSYTHE HOUSE, CROMAC SQUARE, BELFAST, UNITED KINGDOM, BT2 8LA

SITE ID : 1929962 MERIDIAN MEDICAL TECHNOLOGIES LIMITED FORSYTHE HOUSE, CROMAC SQUARE, BELFAST, UNITED KINGDOM, BT2 8LA

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 8794

MICROPHARM LIMITED UNITS F & G, STATION ROAD INDUSTRIAL ESTATE, NEWCASTLE EMLYN, UNITED KINGDOM, SA38 9BY

SITE ID : 22532 MICROPHARM LIMITED UNITS F & G, STATION ROAD INDUSTRIAL ESTATE, NEWCASTLE EMLYN, UNITED KINGDOM, SA38 9BY

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES BIOLOGICAL ACTIVE STARTING MATERIALS OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT

SITE ID : 114485 MICROPHARM LIMITED UNITS B2, B1 & D1, ANTUR TEIFI BUSINESS PARK, NEWCASTLE EMLYN, UNITED KINGDOM, SA38 9DB

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES BIOLOGICAL ACTIVE STARTING MATERIALS OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 77 of 147 Licence Holder MS 21426

MID CHESHIRE HOSPITALS NHS FOUNDATION TRUST PHARMACY DEPARTMENT, LEIGHTON HOSPITAL, MIDDLEWICH ROAD, CREWE, UNITED KINGDOM, CW1 4QJ

SITE ID : 30586 MID CHESHIRE HOSPITALS NHS FOUNDATION TRUST PHARMACY DEPARTMENT, LEIGHTON HOSPITAL, MIDDLEWICH ROAD, CREWE, UNITED KINGDOM, CW1 4QJ

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS MONOCLONAL ANTIBODIES

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) CEPHALOSPORIN; PENICILLIN; CLARITHROMYCIN ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 15109

MID ESSEX HOSPITAL SERVICES NHS TRUST BROOMFIELD HOSPITAL, COURT ROAD, CHELMSFORD, UNITED KINGDOM, CM1 7ET

SITE ID : 6115 MID ESSEX HOSPITAL SERVICES NHS TRUST

BROOMFIELD HOSPITAL, COURT ROAD, CHELMSFORD, UNITED KINGDOM, CM1 7ET

Licence Holder MS 6647

MILLER & MILLER (CHEMICALS) LIMITED UNIT 3, BURNSIDE INDUSTRIAL ESTATE, 49-53 ROEBUCK ROAD, HAINAULT, UNITED KINGDOM, IG6 3UG

SITE ID : 27351 MILLER & MILLER (CHEMICALS) LIMITED UNIT 3, BURNSIDE INDUSTRIAL ESTATE, 49-53 ROEBUCK ROAD, HAINAULT, UNITED KINGDOM, IG6 3UG

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 78 of 147 Licence Holder MS 15360

MINISTRY OF DEFENCE - MEDICAL AND GENERAL SUPPLIES TEAM MEDICAL INVENTORY SECTION, ELM2B, 4226, MOD ABBEY WOOD, BRISTOL, UNITED KINGDOM, BS34 8JH

SITE ID : 9518211 MINISTRY OF DEFENCE MEDICAL AND GENERAL SUPPLIES TEAM, MEDICAL COUNTER MEASURES SECTION, ELM 2B MAILPOINT 4226, MOD ABBEY WOOD, BRISTOL, UNITED KINGDOM, BS34 8JH

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 28335

MMEU LIMITED IRON FARM, 7 GRIMES GATE, DISEWORTH, UNITED KINGDOM, DE74 2QD

SITE ID : 7732705 MMEU LIMITED

4 LANGLEY CLOSE, SHEFFIELD, UNITED KINGDOM, S65 3QG

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 14172

MOVIANTO UK LIMITED 1A PROGRESS PARK, ELSTOW, BEDFORD, UNITED KINGDOM, MK42 9XE

SITE ID : 5680 MOVIANTO UK LIMITED 1A PROGRESS PARK, ELSTOW, BEDFORD, UNITED KINGDOM, MK42 9XE

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 79 of 147 Licence Holder MS 5954

MR ALAN BROCH 225 WEST END LANE, LONDON, UNITED KINGDOM, NW6 1XJ

SITE ID : 16798 MR ALAN BROCH 225 WEST END LANE, LONDON, UNITED KINGDOM, NW6 1XJ

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 21551

MUNDIPHARMA RESEARCH LIMITED UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, UNITED KINGDOM, CB4 0GW

SITE ID : 104666 MUNDIPHARMA RESEARCH LIMITED UNIT 137, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, UNITED KINGDOM, CB4 0GW

SITE ID : 8800391 MUNDIPHARMA RESEARCH LIMITED MAIN BUILDING UNIT 191, SECOND FLOOR PILOT PLANT, CAMBRIDGE SCIENCE PARK, CAMBRIDGE, UNITED KINGDOM, CB4 0GW

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL OTHER NON-STERILE MEDICINAL PRODUCTS PACKAGING & LABELLING OF TRANSDERMAL PATCHES, SOFT GELATIN CAPSULES, PRIMARY PACKAGING SUPPOSITORIES AND PESSARIES. LABELLING OF ASEPTIC OR TERMINALLY STERILISED PREPARATIONS, MEDICAL DEVICES AN LICENSABLE DRESSINGS PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TRANSDERMAL PATCHES

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 80 of 147 Licence Holder MS 13485

MW ENCAP LIMITED UNITS 4,5 & 6 OAKBANK PARK WAY, LIVINGSTON, UNITED KINGDOM, EH53 0TH

SITE ID : 85964 MW ENCAP LIMITED BUILDING 1, UNITS 4, 5 & 6, OAKBANK PARK WAY, MID CALDER, LIVINGSTON, UNITED KINGDOM, EH53 0TH

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Licence Holder MS 16950

NAPP PHARMACEUTICALS LIMITED CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, UNITED KINGDOM, CB4 0AB

SITE ID : 21989 BARD PHARMACEUTICALS LIMITED UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE, UNITED KINGDOM, CB4 0GW

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 81 of 147 Licence Holder MS 17136

NEWCASTLE-UPON-TYNE HOSPITALS NHS FOUNDATION TRUST ROYAL VICTORIA INFIRMARY, QUEEN VICTORIA ROAD, NEWCASTLE UPON TYNE, UNITED KINGDOM, NE1 4LP

SITE ID : 9776 ROYAL VICTORIA INFIRMARY (RVI), PHARMACY PRODUCTION & QC UNIT ROYAL VICTORIA INFIRMARY, QUEEN VICTORIA ROAD, NEWCASTLE UPON TYNE, UNITED KINGDOM, NE1 4LP

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLOLLIPOPS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGEYEDROPS DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 27870 NEWCASTLE FREEMAN NM UNIT RMPD FREEMAN ROAD, NEWCASTLE UPON TYNE, UNITED KINGDOM, NE7 7DN

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGRADIOPHARMACEUTICALS DOSAGE FORMS)

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES RADIOPHARMACEUTICALS/RADIONUCLIDE GENERATORS

SITE ID : 865904 NEWCASTLE BMF HAEMATOLOGICAL SCIENCES HAEMATOLOGICAL SCIENCES, INSTITUTE OF CELLULAR MEDICINE, FRAMLINGTON PLACE, NEWCASTLE UPON TYNE, UNITED KINGDOM, NE2 4HH

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS GENE THERAPY PRODUCTS

BIOLOGICAL MEDICINAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS TISSUE ENGINEERED PRODUCTS

OTHER NON-STERILE MEDICINAL PRODUCTS PACKAGING ONLY PRIMARY PACKAGING CELL THERAPIES, TISSUE ENGINEERED PRODUCTS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES BIOLOGICAL ACTIVE STARTING MATERIALS OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGCELLULAR DOSAGE THERAPIES, FORMS) TISSUE ENGINEERED PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 82 of 147 SITE ID : 2431088 NEWCASTLE BMF ICFL BIOSCIENCE CENTRE, INTERNATIONAL CENTRE FOR LIFE, TIMES SQUARE, NEWCASTLE UPON TYNE, UNITED KINGDOM, NE1 3BZ

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS TISSUE ENGINEERED PRODUCTS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES BIOLOGICAL ACTIVE STARTING MATERIALS OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

SITE ID : 7664665 NEWCASTLE-UPON-TYNE HOSPITALS NHS FOUNDATION TRUST NUCLEAR MEDICINE DEPARTMENT, ROYAL VICTORIA INFIRMARY, QUEEN VICTORIA ROAD, NEWCASTLE UPON TYNE, UNITED KINGDOM, NE1 4LP

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OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWING DOSAGE FORMS) RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 83 of 147 Licence Holder MS 30050

NEWCASTLE-UPON-TYNE HOSPITALS NHS FOUNDATION TRUST REGIONAL MEDICAL PHYSICS DEPARTMENT REGIONAL MEDICAL PHYSICS DEPARTMENT, FREEMAN HOSPITAL, FREEMAN ROAD, HIGH HEATON, NEWCASTLE-UPON-TYNE, UNITED KINGDOM, NE7 7DN

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NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE

NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE NON-STERILE FORMS) MEDICINAL PRODUCTS RADIOPHARMACEUTICALS.

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 261906 HARTLEPOOL NM UNIT RMPD HOLDFORTH ROAD, HARTLEPOOL, UNITED KINGDOM, TS24 9AH

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

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NHS BLOOD AND TRANSPLANT PLYMOUTH GROVE, MANCHESTER, UNITED KINGDOM, M13 9LL

SITE ID : 119781 LIVERPOOL BLOOD CENTRE 14 ESTUARY BANKS, SPEKE, LIVERPOOL, UNITED KINGDOM, L24 8RB

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 84 of 147 Licence Holder MS 24712

NHS GREATER GLASGOW AND CLYDE REGIONAL QUALITY ASSURANCE SERVICE, WARD 23, STOBHILL HOSPITAL, 133 BALORNOCK ROAD, GLASGOW, UNITED KINGDOM, G21 3UW

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PHARMACY PRODUCTION UNIT, UNIVERSITY PLACE, GLASGOW, UNITED KINGDOM, G11 6NT

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BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGMEDICINAL DOSAGE GASES FORMS)

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STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ASEPTICALLY FORMS) PREPARED PRODUCTS PET RADIOPHARMACEUTICAL

Date of Publication 01 August 2015 Human Only Page 85 of 147 Licence Holder MS 30037

NHS HIGHLAND RAIGMORE HOSPITAL, OLD PERTH ROAD, INVERNESS, HIGHLAND, UNITED KINGDOM, IV2 3UJ

SITE ID : 89363 MEDICAL PHYSICS DEPARTMENT RAIGMORE HOSPITAL, OLD PERTH ROAD, INVERNESS, UNITED KINGDOM, IV2 3UJ

SITE ID : 312317 PHARMACY DEPARTMENT RAIGMORE HOSPITAL, OLD PERTH ROAD, INVERNESS, UNITED KINGDOM, IV2 3UJ

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING REPACKAGING OF AMPOULES ASSEMBLY OF EMERGENCY PACKS PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING TABLETS

Licence Holder MS 23153

NHS LOTHIAN - UNIVERSITY HOSPITALS DIVISION LITTLE FRANCE CRESCENT, OLD DALKEITH ROAD, THE ROYAL INBFIRMARY OF EDINBURGH, 51, EDINBURGH, MIDLOTHIAN, UNITED KINGDOM, EH16 4SA

SITE ID : 27599 RADIOPHARMACY 51 LITTLE FRANCE CRESCENT, EDINBURGH, UNITED KINGDOM, EH16 4SA

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 86 of 147 Licence Holder MS 3473

NHS NATIONAL SERVICES SCOTLAND 21 ELLENS GLEN ROAD, EDINBURGH, UNITED KINGDOM, EH17 7QT

SITE ID : 21113 NORTH EAST SCOTLAND BLOOD TRANSFUSION SERVICE FORESTERHILL ROAD, ABERDEEN, UNITED KINGDOM, AB25 2ZW

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES BIOLOGICAL ACTIVE STARTING MATERIALS OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGFROZEN DOSAGE SUSPENSION FORMS) OF LYMPHOCYTE CELLS (ATMP)

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BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGHUMAN DOSAGE DERIVED FORMS) ATMPS AS STIPULATED IN 1394/2007

Date of Publication 01 August 2015 Human Only Page 87 of 147 Licence Holder MS 2000

NORBROOK LABORATORIES LIMITED STATION WORKS, CAMLOUGH ROAD, NEWRY, UNITED KINGDOM, BT35 6JP

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OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CORTICOSTEROIDS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) PRESSURISED PREPARATIONS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SUPPOSITORIES NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS SUPPOSITORIES SOLID NON-STERILE DOSAGE FORMS TABLETS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING PRESSURISED PREPARATIONS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SEMI-SOLIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SOLIDS AND IMPLANTS TERMINALLY STERILISED SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 88 of 147 SITE ID : 12919 ARMAGH ROAD SITE 105 ARMAGH ROAD, NEWRY, UNITED KINGDOM, BT35 6PU

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CORTICOSTEROIDS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) PRESSURISED PREPARATIONS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS TABLETS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 89 of 147 SITE ID : 89419 NORBROOK LABORATORIES LIMITED FACTORY NO 4, CARNBANE INDUSTRIAL ESTATE, NEWRY, UNITED KINGDOM, BT35 6QQ

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CORTICOSTEROIDS, HORMONES.

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, SOFT SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) PRESSURISED PREPARATIONS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SUPPOSITORIES NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS CAPSULES, SOFT SHELL SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS SUPPOSITORIES SOLID NON-STERILE DOSAGE FORMS TABLETS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE PRIMARY PACKAGING OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING PRESSURISED PREPARATIONS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 90 of 147 Licence Holder MS 13630

NORFOLK AND NORWICH UNIVERSITY HOSPITAL NHS FOUNDATION TRUST COLNEY LANE, NORWICH, UNITED KINGDOM, NR4 7UY

SITE ID : 29402 NORFOLK AND NORWICH UNIVERSITY HOSPITALS NHS FOUNDATION TRUST COLNEY LANE, NORWICH, UNITED KINGDOM, NR4 7UY

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) ASSEMBLY OF KITS CONSISTING OF LICENSED PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SUPPOSITORIES SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS SUPPOSITORIES UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

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NORGINE LIMITED NORGINE HOUSE, WIDEWATER PLACE, MOORHALL ROAD, HAREFIELD, UXBRIDGE, UNITED KINGDOM, UB9 6NS

SITE ID : 14798 NORGINE LIMITED NEW ROAD, TIR-Y-BERTH, HENGOED, UNITED KINGDOM, CF82 8SJ

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL

Date of Publication 01 August 2015 Human Only Page 91 of 147 Licence Holder MS 13646

NORTHAMPTON GENERAL HOSPITAL NHS TRUST CLIFTONVILLE, NORTHAMPTON, UNITED KINGDOM, NN1 5BD

SITE ID : 22201 NORTHAMPTON GENERAL HOSPITAL NHS TRUST PHARMACY DEPARTMENT, CLIFTONVILLE, NORTHAMPTON, UNITED KINGDOM, NN1 5BD

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS MONOCLONAL ANTIBODY PREPARATIONS.

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS PENICILLIN, CEPHALOSPORIN'S, ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGCYTOSTATICS/CYTOTOXICS DOSAGE FORMS) AND RADIOACTIVE MATERIALS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

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NORTH CUMBRIA UNIVERSITY HOSPITALS NHS TRUST CUMBERLAND INFIRMARY, NEWTOWN ROAD, CARLISLE, UNITED KINGDOM, CA2 7HY

SITE ID : 8057063 CARLISLE NM UNIT MEDICAL PHYSICS DEPARTMENT, CUMBERLAND INFIRMARY, NEWTOWN ROAD, CARLISLE, UNITED KINGDOM, CA2 7HY

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE

NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE NON-STERILE FORMS) MEDICINAL PRODUCTS RADIOPHARMACEUTICALS

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NORTHUMBRIA HEALTHCARE NHS FOUNDATION TRUST 7-8 SILVER FOX WAY, COBALT BUSINESS PARK, SILVER LINK, NEWCASTLE UPON TYNE, UNITED KINGDOM, NE27 0QJ

SITE ID : 10632590 NORTHUMBRIA HEALTHCARE NHS FOUNDATION TRUST PHARMACY PRODUCTION UNIT, WANSBECK GENERAL HOSPITAL, WOODHORN LANE, ASHINGTON, UNITED KINGDOM, NE63 9JJ

Date of Publication 01 August 2015 Human Only Page 92 of 147 Licence Holder MS 19162

NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST PHARMACY PRODUCTION, QUEENS MEDICAL CENTRE, DERBY ROAD, NOTTINGHAM, UNITED KINGDOM, NG7 2UH

SITE ID : 3457 THE QMC PHARMACY MANUFACTURING UNIT

PHARMACY PRODUCTION, QUEENS MEDICAL CENTRE, DERBY ROAD, NOTTINGHAM, UNITED KINGDOM, NG7 2UH

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS HEPARIN INJECTION (USING PRODUCT BIOLOGICAL MEDICINAL PRODUCTS LICENSED INGREDIENTS) AND MONOCLONAL ANTIBODIES (FROM PRODUCT LICENSED INGREDIENTS)

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS PESSARIES, MULTI AND UNIT DOSE POWDERS, NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGMAY INCLUDE DOSAGE CYTOTOXICS FORMS) AND OTHER HAZARDOUS MATERIALS. OVERLABELLING OF INHALERS. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGCYTOTOXICS DOSAGE AND FORMS) RADIOLABELLED PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 327827 THE QMC RADIOPHARMACY QUEENS MEDICAL CENTRE CAMPUS, DERBY ROAD, NOTTINGHAM, UNITED KINGDOM, NG7 2UH

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGRADIOPHARMACEUTICALS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 93 of 147 Licence Holder MS 13581

NOVA LABORATORIES LIMITED MARTIN HOUSE, GLOUCESTER CRESCENT, WIGSTON, LEICESTER, UNITED KINGDOM, LE18 4YL

SITE ID : 4097 NOVA LABORATORIES LIMITED MARTIN HOUSE, GLOUCESTER CRESCENT, WIGSTON, LEICESTER, UNITED KINGDOM, LE18 4YL

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS ASEPTIC FILTRATION AND FILLING OF BIOLOGICAL MEDICINAL PRODUCTS SYNTHETIC PROTEINS, INCLUDING IMMUNOLOGICAL PRODUCTS (E.G. CANCER AND CONTRACEPTIVE VACCINES).

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SACHETS, PESSARIES, POWDERS (INTERNAL AND EXTERNAL) NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SUPPOSITORIES SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS SUPPOSITORIES UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LYOPHILISATES ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SEMI-SOLIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SOLIDS AND IMPLANTS TERMINALLY STERILISED LARGE VOLUME LIQUIDS TERMINALLY STERILISED SEMI-SOLIDS TERMINALLY STERILISED SMALL VOLUME LIQUIDS

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NOVARTIS PHARMACEUTICALS UK LIMITED FRIMLEY BUSINESS PARK, FRIMLEY, CAMBERLEY, UNITED KINGDOM, GU16 7SR

SITE ID : 1135 NOVARTIS PHARMACEUTICALS UK LIMITED

FRIMLEY BUSINESS PARK, FRIMLEY, CAMBERLEY, UNITED KINGDOM, GU16 7SR

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 94 of 147 Licence Holder MS 19559

NUPHARM LABORATORIES LIMITED 2 NEWTECH SQUARE, DEESIDE INDUSTRIAL PARK, DEESIDE, UNITED KINGDOM, CH5 2NT

SITE ID : 104765 NUPHARM LABORATORIES LIMITED 2 NEWTECH SQUARE, DEESIDE INDUSTRIAL PARK, DEESIDE, UNITED KINGDOM, CH5 2NT

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS MANUFACTURE OF NALTREXONE SUBCUTANEOUS IMPLANT IN APPLICATOR. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGPRODUCTS DOSAGE ARE FORMS) TERMINALLY STERLISED BY GAMMA IRRADIATION PERFORMED BY A CONTRACT SERVICE PROVIDER. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

OTHER PREPARATION AND ASSEMBLY OF SOLID PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES IMPLANTS (FOR TERMINAL STERILISATION BY THIRD-PARTY SERVICE PROVIDER). OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

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OLDHAM NHS TRUST ROCHDALE ROAD, OLDHAM, MANCHESTER, UNITED KINGDOM, OL1 2JH

SITE ID : 9448 PHARMACY DEPARTMENT, ROYAL OLDHAM HOSPITAL

ROCHDALE ROAD, OLDHAM, MANCHESTER, UNITED KINGDOM, OL1 2JH

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 95 of 147 Licence Holder MS 15814

OPD LABORATORIES LIMITED UNIT 6 COLONIAL WAY, OFF RADLETT ROAD, WATFORD, UNITED KINGDOM, WD24 4PR

SITE ID : 19754 OPD LABORATORIES LIMITED UNIT 5-7, COLONIAL WAY, WATFORD, UNITED KINGDOM, WD24 4YR

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 21439

OXFORD UNIVERSITY HOSPITALS NHS TRUST OLD ROAD, HEADINGTON, OXFORD, UNITED KINGDOM, OX3 7LE

SITE ID : 29063 NUCLEAR MEDICINE UNIT OLD ROAD, HEADINGTON, OXFORD, UNITED KINGDOM, OX3 7LE

Date of Publication 01 August 2015 Human Only Page 96 of 147 Licence Holder MS 13163

PACKPHARM LIMITED UNIT 14D, WENDOVER ROAD, RACKHEATH INDUSTRIAL ESTATE, RACKHEATH, NORWICH, UNITED KINGDOM, NR13 6LH

SITE ID : 8515 PACKPHARM LIMITED UNIT 14D, WENDOVER ROAD, RACKHEATH INDUSTRIAL ESTATE, RACKHEATH, NORWICH, UNITED KINGDOM, NR13 6LH

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS GENE THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING CHEWING GUMS PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS EFFERVESCENT GRANULES, CAPSULES, PRIMARY PACKAGING AEROSOLS, INJECTABLES. THE FILLING OF PRIMARY CONTAINERS INCLUDES TABLETS AND CAPSULES ONLY. PRIMARY PACKAGING PRESSURISED PREPARATIONS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS PRIMARY PACKAGING TRANSDERMAL PATCHES

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY OF PARALLEL IMPORTED PRODUCTS OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 4351

PENN PHARMACEUTICAL SERVICES LIMITED UNITS 23-24, TAFARNAUBACH INDUSTRIAL ESTATE, TAFARNAUBACH, TREDEGAR, UNITED KINGDOM, NP22 3AA

SITE ID : 15302 PENN PHARMACEUTICAL SERVICES LIMITED

UNITS 23-24, TAFARNAUBACH INDUSTRIAL ESTATE, TAFARNAUBACH, TREDEGAR, UNITED KINGDOM, NP22 3AA

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 97 of 147 Licence Holder MS 39930

PEPCEUTICALS LIMITED 4 FELDSPAR CLOSE, ENDERBY, LEICESTER, UNITED KINGDOM, LE19 4JS

SITE ID : 3649399 PEPCEUTICALS LIMITED 4 FELDSPAR CLOSE, ENDERBY, LEICESTER, UNITED KINGDOM, LE19 4JS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGMANUFACTURE DOSAGE FORMS) OF PEPTIDES AND SMALL MOLECULES AS API AND FOR IMP STUDIES NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS)

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 35517

PERCURO MEDICA LIMITED 2 CUNARD ROAD, PARK ROYAL, LONDON, UNITED KINGDOM, NW10 6PN

SITE ID : 10042 PERCURO MEDICA LIMITED 2 CUNARD ROAD, PARK ROYAL, LONDON, UNITED KINGDOM, NW10 6PN

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 98 of 147 Licence Holder MS 57

PFIZER LIMITED RAMSGATE ROAD, SANDWICH, UNITED KINGDOM, CT13 9NJ

SITE ID : 16600 PFIZER LIMITED RAMSGATE ROAD, SANDWICH, UNITED KINGDOM, CT13 9NJ

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS MONOCLONAL ANTIBODIES. BIOLOGICALLY DERIVED LARGE MOLECULAR ENTITIES.

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, SOFT SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) INHALATION DEVICES NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) PRESSURISED PREPARATIONS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SUPPOSITORIES NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS CAPSULES, SOFT SHELL SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS SUPPOSITORIES SOLID NON-STERILE DOSAGE FORMS TABLETS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

Date of Publication 01 August 2015 Human Only Page 99 of 147 Licence Holder MS 21554

PHARMASPEC LIMITED UNIT 31, BORDESLEY TRADING ESTATE, BORDESLEY GREEN ROAD, BORDESLEY GREEN, BIRMINGHAM, UNITED KINGDOM, B8 1BZ

SITE ID : 21993 PHARMASPEC LIMITED UNIT 31, BORDESLEY TRADING ESTATE, BORDESLEY GREEN ROAD, BORDESLEY GREEN, BIRMINGHAM, UNITED KINGDOM, B8 1BZ

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE SOFT FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

Licence Holder MS 18515

PHARMASURE LIMITED 28 WATFORD METRO CENTRE, DWIGHT ROAD, WATFORD, UNITED KINGDOM, WD18 9SB

SITE ID : 83864 PHARMASURE LIMITED

28 WATFORD METRO CENTRE, DWIGHT ROAD, WATFORD, UNITED KINGDOM, WD18 9SB

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 100 of 147 Licence Holder MS 30514

PHARMATERIALS LIMITED 5 BOULTON ROAD, READING, UNITED KINGDOM, RG2 0NH

SITE ID : 876362 PHARMATERIALS LIMITED 5 BOULTON ROAD, READING, UNITED KINGDOM, RG2 0NH

NON-STERILE PRODUCTS BATCH CERTIFICATION BATCH CERTIFICATION NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGPRESSURISED DOSAGE PREPARATIONSFORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING PRESSURISED METERED DOSE INHALER, DRY POWDER INHALER. PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING PRESSURISED PREPARATIONS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES OTHER SITE OF PHYSICAL IMPORTATION OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 101 of 147 Licence Holder MS 29595

PIRAMAL HEALTHCARE UK LIMITED WHALTON ROAD, MORPETH, NORTHUMBERLAND, UNITED KINGDOM, NE61 3YA

SITE ID : 18244 PIRAMAL HEALTHCARE UK LIMITED WHALTON ROAD, MORPETH, UNITED KINGDOM, NE61 3YA

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) DRY POWDER FOR ORAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS TABLETS

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS

Licence Holder MS 19720

PLYMOUTH HOSPITALS NHS TRUST THE RADIOPHARMACY UNIT, DEPT OF NUCLEAR MEDICINE, DERRIFORD HOSPITAL, PLYMOUTH, UNITED KINGDOM, PL6 8DH

SITE ID : 422870 PLYMOUTH HOSPITALS NHS TRUST PHARMACY, LEVEL 05, DERRIFORD HOSPITAL, PLYMOUTH, UNITED KINGDOM, PL6 8DH

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES RADIOPHARMACEUTICALS/RADIONUCLIDE GENERATORS

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS TERMINALLY STERILISED PRODUCTS

Date of Publication 01 August 2015 Human Only Page 102 of 147 Licence Holder MS 36764

PONTYPRIDD AND RHONDDA NHS TRUST USE CWM TAF HEALTH BOARD ASEPTIC SERVICES UNIT, PHARMACY DEPARTMENT, ROYAL GLAMORGAN HOSPITAL, YNYSMAERDY, LLANTRISANT, UNITED KINGDOM, CF72 8XR

SITE ID : 12990 PONTYPRIDD AND RHONDDA NHS TRUST USE CWM TAF HEALTH BOARD ASEPTIC SERVICES UNIT, PHARMACY DEPARTMENT, ROYAL GLAMORGAN HOSPITAL, YNYSMAERDY, LLANTRISANT, UNITED KINGDOM, CF72 8XR

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 13142

PORTSMOUTH HOSPITALS NHS TRUST UNIT D2, RAILWAY TRIANGLE, WALTON ROAD, PORTSMOUTH, UNITED KINGDOM, PO6 1TF

SITE ID : 568618 PHARMACY MANUFACTURING UNIT

UNIT D2, RAILWAY TRIANGLE, WALTON ROAD, PORTSMOUTH, UNITED KINGDOM, PO6 1TF

Licence Holder MS 17269

PROTHERICS UK LIMITED BLAENWAUN FFOSTRASOL, LLANDYSUL, UNITED KINGDOM, SA44 5JT

SITE ID : 22626 PROTHERICS UK LIMITED BLAENWAUN FFOSTRASOL, LLANDYSUL, UNITED KINGDOM, SA44 5JT

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS

OTHER ASEPTICALLY PREPARED PRODUCTS FORMULATED BULK PRODUCT IS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGMANUFACTURED DOSAGE FORMS) AT THIS SITE AND TRANSFERRED TO AN EXTERNAL CONTRACTOR FOR STERILE FILTRATION, FILLING AND LYOPHILISATION.

Date of Publication 01 August 2015 Human Only Page 103 of 147 Licence Holder MS 42195

PUBLIC HEALTH ENGLAND VACCINES & COUNTERMEASURES RESPONSE, 4TH FLOOR, SOUTH WING, WELLINGTON HOUSE, 153-155 WATERLOO ROAD, LONDON, UNITED KINGDOM, SE1 8UG

SITE ID : 8467466 PUBLIC HEALTH ENGLAND VACCINES & COUNTERMEASURES RESPONSE, 4TH FLOOR, SOUTH WING, WELLINGTON HOUSE, 153-155 WATERLOO ROAD, LONDON, UNITED KINGDOM, SE1 8UG

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 29581

QUALASEPT LIMITED UNIT 15A, FIVEWAYS INDUSTRIAL ESTATE, WEST WELLS ROAD, CORSHAM, UNITED KINGDOM, SN13 9RG

SITE ID : 297142 QUALASEPT LIMITED (ASU CORSHAM) UNIT 15A, FIVEWAYS INDUSTRIAL ESTATE, WEST WELLS ROAD, CORSHAM, UNITED KINGDOM, SN13 9RG

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS PENICILLINES, CEPHALOSPORINS, CYTOSTATICS/CYTOTOXICS.

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 104 of 147 Licence Holder MS 21923

QUANTUM PHARMACEUTICAL LIMITED HEAD OFFICE, QUANTUM HOUSE, HOBSON INDUSTRIAL ESTATE, HOBSON, NEWCASTLE UPON TYNE, UNITED KINGDOM, NE16 6EA

SITE ID : 378858 QUANTUM PHARMACEUTICAL LIMITED HEAD OFFICE, QUANTUM HOUSE, HOBSON INDUSTRIAL ESTATE, HOBSON, NEWCASTLE UPON TYNE, UNITED KINGDOM, NE16 6EA

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGREEFERS, DOSAGE BARS FORMS) OF SOAP, LOZENGES, PASTILLES, LOLLIPOPS. HAZARDOUS RMS: NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS)

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS SCHEDULE 2 CONTROLLED SUBSTANCES, COMPOUNDED ANTIBIOTICS, CYTOTOXICS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWING(CHEMOTHERAPY), DOSAGE FORMS) HORMONAL AND STEROIDAL PREPARATIONS, MONOCLONAL ANTIBIOTICS, COMPOUNDING OF EYE DROPS. ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 105 of 147 Licence Holder MS 20300

QUAY PHARMACEUTICALS LIMITED QUAY HOUSE, UNIT 28, PARKWAY, DEESIDE INDUSTRIAL PARK, DEESIDE, UNITED KINGDOM, CH5 2NS

SITE ID : 13331 QUAY PHARMACEUTICALS LIMITED 3-4 APEX COURT, BASSENDALE ROAD, WIRRAL, UNITED KINGDOM, CH62 3RE

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS CYTOTOXIC MATERIALS, STEROIDS AND SACHETS. FINAL FORMULATION, FILLING, NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGMANUFACTURE, DOSAGE FORMS) PACKING OF BIOLOGICAL/ORGANIC FINISHED PRODUCTS FOR NON-STERILE APPLICATIONS. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS

SITE ID : 1372957 QUAY PHARMACEUTICALS LIMITED QUAY HOUSE, UNIT 28, PARKWAY, DEESIDE INDUSTRIAL PARK, DEESIDE, UNITED KINGDOM, CH5 2NS

NON-STERILE PRODUCTS BATCH CERTIFICATION BATCH CERTIFICATION BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS CYTOTOXIC MATERIALS, STEROIDS AND SACHETS. FINAL FORMULATION, FILLING, NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGMANUFACTURE, DOSAGE FORMS) PACKING OF BIOLOGICAL/ORGANIC FINISHED PRODUCTS FOR NON-STERILE APPLICATIONS. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 106 of 147 Licence Holder MS 21305

QUEEN VICTORIA HOSPITAL NHS FOUNDATION TRUST EYE BANK, CORNEO PLASTIC UNIT, QUEEN VICTORIA HOSPITAL, HOLTYE ROAD, EAST GRINSTEAD, UNITED KINGDOM, RH19 3DZ

SITE ID : 21312 QUEEN VICTORIA HOSPITAL NHS FOUNDATION TRUST EYE BANK, CORNEO PLASTIC UNIT, QUEEN VICTORIA HOSPITAL, HOLTYE ROAD, EAST GRINSTEAD, UNITED KINGDOM, RH19 3DZ

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) PREPARATION OF AUTOLOGOUS AND ALLOGENEIC CELL CULTURES FOR HUMAN APPLICATION. OTHER TERMINALLY STERILISED PREPARED TERMINALLY STERILISED PRODUCTS INCLUDES THE USE OF IRRADIATED MURINE FIBROBLASTS.

Licence Holder MS 34116

QUEST HEALTHCARE LIMITED UNIT 5, MOUNT STREET BUSINESS PARK, MOUNT STREET, NECHELLS, BIRMINGHAM, UNITED KINGDOM, B7 5QU

SITE ID : 488850 QUEST HEALTHCARE LIMITED

UNIT 5, MOUNT STREET BUSINESS PARK, MOUNT STREET, NECHELLS, BIRMINGHAM, UNITED KINGDOM, B7 5QU

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGPOWDERS DOSAGE IN BOTTLES FORMS) OR SACHETS. FAST MELT TABLETS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING POWEDERS IN BOTTLES OR SACHETS. FAST MELT TABLETS PRIMARY PACKAGING SEMI-SOLIDS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

OTHER ASEPTICALLY PREPARED PRODUCTS PARENTERAL NUTRITION, PATIENT STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGCONTROLLED DOSAGE ANALGESIA, FORMS) CENTRAL INTRAVENOUS ADDITIVES, MONOCLONAL ANTIBODIES, CYTOTOXICS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 107 of 147 Licence Holder MS 43544

QUEST HEALTHCARE SOLUTIONS LIMITED UNIT 5, MOUNT STREET BUSINESS PARK, NECHELLS, BIRMINGHAM, UNITED KINGDOM, B7 5QU

SITE ID : 10572449 QUEST HEALTHCARE SOLUTIONS LIMITED UNIT 5, MOUNT STREET BUSINESS PARK, NECHELLS, BIRMINGHAM, UNITED KINGDOM, B7 5QU

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING POWDERS IN BOTTES OR SACHETS. FAST MELT TABLETS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Licence Holder MS 35718

QUOTIENT CLINICAL LIMITED TRENT HOUSE, MERE WAY, RUDDINGTON FIELDS BUSINESS PARK, RUDDINGTON, NOTTINGHAM, UNITED KINGDOM, NG11 6JS

SITE ID : 8697 QUOTIENT CLINICAL LIMITED TRENT HOUSE/SHERWOOD HOUSE, MERE WAY, RUDDINGTON FIELDS, RUDDINGTON, NOTTINGHAM, UNITED KINGDOM, NG11 6JS

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS ASEPTIC ASSEMBLY OF PREFORMULATED BIOLOGICALS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGMEDICINAL DOSAGE GASES FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGPRESSURISED DOSAGE PREPARATIONSFORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 108 of 147 Licence Holder MS 12588

RADIOPHARMACY SERVICES, SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST RADIOPHARMACY/NUCLEAR MEDICINE DEPARTMENT, VICKERS CORRIDOR, NORTHERN GENERAL HOSPITAL, SHEFFIELD, UNITED KINGDOM, S5 7AU

SITE ID : 1986807 RADIOPHARMACY, NORTHERN GENERAL HOSPITAL RADIOPHARMACY/NUCLEAR MEDICINE DEPARTMENT, VICKERS CORRIDOR, NORTHERN GENERAL HOSPITAL, SHEFFIELD, UNITED KINGDOM, S5 7AU

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) OTHER ASEPTICALLY PREPARED PRODUCTS RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 41521

RECIPHARM LIMITED VALE OF BARDSLEY, ASHTON-UNDER-LYNE, UNITED KINGDOM, OL7 9RR

SITE ID : 16682 RECIPHARM LIMITED VALE OF BARDSLEY, ASHTON-UNDER-LYNE, UNITED KINGDOM, OL7 9RR

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL

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REGENERYS LIMITED THE INNOVATION CENTRE, 217 PORTOBELLO, SHEFFIELD, UNITED KINGDOM, S1 4DP

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STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ASEPTICALLY FORMS) PREPARED PRODUCTS CELL THERAPY PRODUCTS

Date of Publication 01 August 2015 Human Only Page 109 of 147 Licence Holder MS 35871

RMS INNOVATIONS (UK) LIMITED UNIT 310, CENTENNIAL PARK, CENTENNIAL AVENUE, ELSTREE, BOREHAMWOOD, UNITED KINGDOM, WD6 3TJ

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BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

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ROCHE PRODUCTS LIMITED 6 FALCON WAY, SHIRE PARK, WELWYN GARDEN CITY, UNITED KINGDOM, AL7 1TW

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ROKSHAW LIMITED UNIT 5A, EAST WAY, RIVERGREEN INDUSTRIAL ESTATE, SUNDERLAND, UNITED KINGDOM, SR4 6AD

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PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

Date of Publication 01 August 2015 Human Only Page 110 of 147 Licence Holder MS 427

ROSEMONT PHARMACEUTICALS LIMITED ROSEMONT HOUSE, YORKDALE INDUSTRIAL PARK, BRAITHWAITE STREET, LEEDS, UNITED KINGDOM, LS11 9XE

SITE ID : 15276 ROSEMONT PHARMACEUTICALS LIMITED

ROSEMONT HOUSE, YORKDALE INDUSTRIAL PARK, BRAITHWAITE STREET, LEEDS, UNITED KINGDOM, LS11 9XE

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

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ROSLIN CELLS LIMITED GMP CELLULAR THERAPY FACILITY, SCOTTISH CENTRE FOR REGENERATIVE MEDICINE, EDINBURGH BIOQUARTER, 5 LITTLE FRANCE DRIVE, EDINBURGH, UNITED KINGDOM, EH16 4UU

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OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGCELLULAT DOSAGE THERAPY FORMS) PRODUCTS (ATMPS), MASTER CELL BANKS OF STEM CELL LINES

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ROYAL BERKSHIRE NHS FOUNDATION TRUST PHYSICS AND CHEMICAL ENGINEERING DEPARTMENT, ROYAL BERKSHIRE HOSPITAL, LONDON ROAD, READING, UNITED KINGDOM, RG1 5AN

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Date of Publication 01 August 2015 Human Only Page 111 of 147 Licence Holder MS 12813

ROYAL CORNWALL HOSPITALS NHS TRUST ROYAL CORNWALL HOSPITAL, TRELISKE, TRURO, UNITED KINGDOM, TR1 3LJ

SITE ID : 307061 ROYAL CORNWALL HOSPITALS NHS TRUST PHARMACY TECHNICAL SERVICES UNIT, ROYAL CORNWALL HOSPITAL, TRELISKE, TRURO, UNITED KINGDOM, TR1 3LJ

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

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ROYAL DEVON AND EXETER NHS FOUNDATION TRUST ROYAL DEVON & EXETER HOSPITAL, BARRACK ROAD, EXETER, UNITED KINGDOM, EX2 5DW

SITE ID : 90434 ROYAL DEVON AND EXETER NHS FOUNDATION TRUST

ROYAL DEVON & EXETER HOSPITAL, BARRACK ROAD, EXETER, UNITED KINGDOM, EX2 5DW

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 112 of 147 Licence Holder MS 11149

ROYAL FREE LONDON NHS FOUNDATION TRUST POND STREET, LONDON, UNITED KINGDOM, NW3 2QG

SITE ID : 104676 ROYAL FREE LONDON NHS FOUNDATION TRUST PHARMACY DEPARTMENT, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, UNITED KINGDOM, NW3 2QG

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGENEMA DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSOLIDS DOSAGE AND IMPLANTS FORMS) TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 122819 ROYAL FREE LONDON NHS FOUNDATION TRUST CENTRE FOR CELL, GENE & TISSUE THERAPEUTICS, POND STREET, LONDON, UNITED KINGDOM, NW3 2QG

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ASEPTICALLY FORMS) PREPARED PRODUCTS ATMPS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSOLIDS DOSAGE AND IMPLANTS FORMS) OTHER TERMINALLY STERILISED PREPARED TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGPRODUCTS DOSAGE SOMATIC FORMS) CELL THERAPIES

SITE ID : 375726 ROYAL FREE LONDON NHS FOUNDATION TRUST RADIOPHARMACY NUCLEAR MEDICINE, THE ROYAL FREE HOSPITAL, POND STREET, LONDON, UNITED KINGDOM, NW3 2QG

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 113 of 147 Licence Holder MS 12155

ROYAL LIVERPOOL & BROADGREEN UNIVERSITY HOSPITALS NHS TRUST ROYAL LIVERPOOL & BROADGREEN UNIVERSITY HOSPITALS, PRESCOTT STREET, LIVERPOOL, UNITED KINGDOM, L7 8XP

SITE ID : 29634 ROYAL LIVERPOOL & BROADGREEN UNIVERSITY HOSPITALS NHS TRUST ROYAL LIVERPOOL & BROADGREEN UNIVERSITY HOSPITALS, PRESCOTT STREET, LIVERPOOL, UNITED KINGDOM, L7 8XP

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS

BIOLOGICAL MEDICINAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS MONOCLONAL ANTIBODIES.

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

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BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

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BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS MONOCLONAL ANTIBODIES.

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 114 of 147 Licence Holder MS 15983

ROYAL MARSDEN NHS FOUNDATION TRUST DEPARTMENT OF PHYSICS, DOWNS ROAD, SUTTON, UNITED KINGDOM, SM2 5PT

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NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGRADIONUCLIDE DOSAGE FORMS) GENERATORS

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Licence Holder MS 11560

ROYAL SURREY COUNTY HOSPITAL NHS FOUNDATION TRUST EGERTON ROAD, GUILDFORD, UNITED KINGDOM, GU2 7XX

SITE ID : 23362 PHARMACY ASEPTIC SERVICES DEPT. PHARMACY DEPARTMENT, ROYAL SURREY COUNTY HOSPITAL, EGERTON ROAD, GUILDFORD, UNITED KINGDOM, GU2 7XX

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Date of Publication 01 August 2015 Human Only Page 115 of 147 Licence Holder MS 13904

SALFORD ROYAL NHS FOUNDATION TRUST PHARMACY DEPARTMENT, SALFORD ROYAL HOSPITAL, STOTT LANE, SALFORD, UNITED KINGDOM, M6 8HD

SITE ID : 22205 SALFORD ROYAL NHS FOUNDATION TRUST PHARMACY DEPARTMENT, SALFORD ROYAL HOSPITAL, STOTT LANE, SALFORD, UNITED KINGDOM, M6 8HD

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Licence Holder MS 33877

SALFORD ROYAL NHS FOUNDATION TRUST (NUCLEAR MEDICINE DEPARTMENT) SALFORD ROYAL HOSPITAL, STOTT LANE, SALFORD, UNITED KINGDOM, M6 8HD

SITE ID : 580759 SALFORD ROYAL NHS FOUNDATION TRUST RADIOPHARMACY, NUCLEAR MEDICINE DEPARTMENT, SALFORD ROYAL HOSPITAL, STOTT LANE, SALFORD, UNITED KINGDOM, M6 8HD

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Date of Publication 01 August 2015 Human Only Page 116 of 147 Licence Holder MS 21457

SANDWELL AND WEST BIRMINGHAM HOSPITALS NHS TRUST CITY HOSPITAL, DUDLEY ROAD, BIRMINGHAM, UNITED KINGDOM, B18 7QH

SITE ID : 90486 SANDWELL AND WEST BIRMINGHAM HOSPITALS NHS TRUST - DEPARTMENT OF PHYSICS AND NUCLEAR MEDICINE UNIVERSITY OF BIRMINGHAM, EDGBASTON, BIRMINGHAM, UNITED KINGDOM, B15 2TT

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NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS

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SHARP CLINICAL SERVICES (UK) LIMITED ASHFIELD HOUSE, RESOLUTION ROAD, ASHBY-DE-LA-ZOUCH, UNITED KINGDOM, LE65 1HW

SITE ID : 28707 SHARP CLINICAL SERVICES (UK) LIMITED ELVICTA BUSINESS PARK, CRICKHOWELL, UNITED KINGDOM, NP8 1DF

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PACKAGING ONLY PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS

Date of Publication 01 August 2015 Human Only Page 117 of 147 Licence Holder MS 27699

SHERWOOD FOREST HOSPITALS NHS FOUNDATION TRUST PHARMACY DEPARTMENT, KING'S MILL HOSPITAL, MANSFIELD ROAD, SUTTON-IN-ASHFIELD, UNITED KINGDOM, NG17 4JL

SITE ID : 90633 KING'S MILL HOSPITAL PHARMACY DEPARTMENT, KING'S MILL HOSPITAL, MANSFIELD ROAD, SUTTON-IN-ASHFIELD, UNITED KINGDOM, NG17 4JL

Licence Holder MS 18258

SHREWSBURY AND TELFORD HOSPITAL NHS TRUST APLEY CASTLE, TELFORD, UNITED KINGDOM, TF1 6TF

SITE ID : 89352 PRINCESS ROYAL HOSPITAL APLEY CASTLE, PHARMACY DEPARTMENT, THE PRINCESS ROYAL HOSPITAL, TELFORD, UNITED KINGDOM, TF1 6TF

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS ERYTHROMYCIN AMPHOTERICIN CYTOTOXIC DRUGS

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ANTIBIOTICS INCLUDING PENICILLINS, ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGCEPHALOSPORINS, DOSAGE FORMS) ERYTHROMYCIN, ANTIFUNGALS INCLUDING AMPHOTERICIN, CYTOSTATICS AND CYTOTOXICS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

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Date of Publication 01 August 2015 Human Only Page 118 of 147 Licence Holder MS 21750

SIEMENS PLC C/O PETNET SOLUTIONS, THE LESLEY HARRISON BUILDING, MOUNT VERNON HOSPITAL, RICKMANSWORTH ROAD, NORTHWOOD, UNITED KINGDOM, HA6 2RN

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LESLEY HARRISON BUILDING, MOUNT VERNON HOSPITAL, NORTHWOOD, UNITED KINGDOM, HA6 2RN

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Date of Publication 01 August 2015 Human Only Page 119 of 147 Licence Holder MS 29808

SIGMA-TAU PHARMA LIMITED ABBEY HOUSE, 1650 ARLINGTON BUSINESS PARK, THEALE, READING, UNITED KINGDOM, RG7 4SA

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PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES BIOLOGICAL ACTIVE STARTING MATERIALS OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 120 of 147 Licence Holder MS 42332

SMARTWAY PHARMACEUTICALS LIMITED 10 LYON ROAD, LONDON, UNITED KINGDOM, SW19 2RL

SITE ID : 9817342 SMARTWAY PHARMACEUTICALS LIMITED 10 LYON ROAD, LONDON, UNITED KINGDOM, SW19 2RL

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 13079

SOUTH DEVON HEALTHCARE NHS FOUNDATION TRUST WILKINS DRIVE, PAIGNTON, UNITED KINGDOM, TQ4 7FG

SITE ID : 3598 SOUTH DEVON HEALTHCARE NHS FOUNDATION TRUST PHARMACEUTICAL MANUFACTURING UNIT, KEMMINGS CLOSE, PAIGNTON, UNITED KINGDOM, TQ4 7TW

PACKAGING ONLY PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER TERMINALLY STERILISED PREPARED TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGPRODUCTS DOSAGE STERILISATION FORMS) OF EMPTY GLASS CONTAINERS/COMPONENTS. TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 121 of 147 Licence Holder MS 21467

SOUTHEND UNIVERSITY HOSPITAL NHS FOUNDATION TRUST PRITTLEWELL CHASE, TRUST HEADQUARTERS, SOUTHEND HOSPITAL, WESTCLIFF-ON-SEA, ESSEX, UNITED KINGDOM, SS0 0RY

SITE ID : 28098 SOUTHEND UNIVERSITY HOSPITAL NHS FOUNDATION TRUST

SOUTHEND HOSPITAL, PRITTLEWELL CHASE, WESTCLIFF-ON-SEA, UNITED KINGDOM, SS0 0RY

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS OVER-LABELLING OF COMMERCIAL,LICENCED OPD PACKS FOR ISSUE TO DISPENSARIES,WARDS AND DEPARTMENTS. PRIMARY PACKAGING BREAKING OF BULK PACKS OF INJECTION AMPOULES AND VIALS INTO SMALLER UNITS, THIS INVOLVES PACKING AND LABELLING OF THE FINAL CONTAINERS ONLY. PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING TABLETS

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS

ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ASEPTICALLY FORMS) PREPARED PRODUCTS RADIOPHARMACEUTICALS. ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 33400

SOUTHERN HEALTH AND SOCIAL CARE TRUST 68 LURGAN ROAD, PORTADOWN, CRAIGAVON, UNITED KINGDOM, BT63 5QQ

SITE ID : 3408 CRAIGAVON AREA HOSPITAL GROUP TRUST 68 LURGAN ROAD, PORTADOWN, CRAIGAVON, UNITED KINGDOM, BT63 5QQ

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING TABLETS

Date of Publication 01 August 2015 Human Only Page 122 of 147 Licence Holder MS 21464

SOUTH TEES HOSPITALS NHS FOUNDATION TRUST JAMES COOK UNIVERSITY HOSPITAL, MARTON ROAD, MIDDLESBROUGH, UNITED KINGDOM, TS4 3BW

SITE ID : 27827 MIDDLESBROUGH NM UNIT RMPD MARTON ROAD, MIDDLESBROUGH, UNITED KINGDOM, TS4 3BW

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 21465

SOUTH TYNESIDE NHS FOUNDATION TRUST SOUTH TYNESIDE DISTRICT HOSPITAL, HARTON LANE, SOUTH SHIELDS, UNITED KINGDOM, NE34 0PL

SITE ID : 91004 CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST - SOUTH TYNESIDE RADIOPHARMACY

HARTON LANE, SOUTH TYNESIDE DISTRICT HOSPITAL, SOUTH SHIELDS, UNITED KINGDOM, NE34 0PL

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) OTHER ASEPTICALLY PREPARED PRODUCTS RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 123 of 147 Licence Holder MS 20701

SOUTH WALES SPECIALS LIMITED 4 CASTELL CLOSE, SWANSEA ENTERPRISE PARK, SWANSEA, UNITED KINGDOM, SA7 9FH

SITE ID : 13818 SOUTH WALES SPECIALS LIMITED 4 CASTELL CLOSE, SWANSEA ENTERPRISE PARK, SWANSEA, UNITED KINGDOM, SA7 9FH

Licence Holder MS 19313

SPRINGFIELD PHARMACY 124 SHEEN ROAD, RICHMOND, UNITED KINGDOM, TW9 1UR

SITE ID : 12056 SPRINGFIELD PHARMACY 124 SHEEN ROAD, RICHMOND, UNITED KINGDOM, TW9 1UR

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 124 of 147 Licence Holder MS 32515

STERLING PHARMACEUTICALS LIMITED 288 UPPER BALSALL HEATH ROAD, BIRMINGHAM, UNITED KINGDOM, B12 9DR

SITE ID : 420743 STERLING PHARMACEUTICALS LIMITED 288 UPPER BALSALL HEATH ROAD, BIRMINGHAM, UNITED KINGDOM, B12 9DR

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, SOFT SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SACHETS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SUPPOSITORIES NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS CAPSULES, SOFT SHELL SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS SUPPOSITORIES SOLID NON-STERILE DOSAGE FORMS TABLETS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING SACHETS PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS OTHER SPECIFIC PROCESSES/ACTIVITIES AIRLINE KITS OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 125 of 147 Licence Holder MS 12853

ST GEORGE'S UNIVERSITY HOSPITALS NHS FOUNDATION TRUST GROUND FLOOR, LANESBOROUGH WING, ST GEORGE'S HOSPITAL, BLACKSHAW ROAD, LONDON, UNITED KINGDOM, SW17 0QT

SITE ID : 286009 ST GEORGE'S HEALTHCARE NHS TRUST GROUND FLOOR, LANESBOROUGH WING, ST GEORGE'S HOSPITAL, BLACKSHAW ROAD, LONDON, UNITED KINGDOM, SW17 0QT

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING OTHER NON-STERILE MEDICINAL PRODUCTS POWDERS PRIMARY PACKAGING TABLETS

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) RADOPHARMACEUTICAL DOSES ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 27718

ST HELEN'S & KNOWSLEY TEACHING HOSPITALS NHS TRUST THE ASEPTIC DISPENSING UNIT (ADU), PHARMACY DEPARTMENT, WHISTON HOSPITAL, WARRINGTON ROAD, PRESCOT, UNITED KINGDOM, L35 5DR

SITE ID : 118288 ST HELEN'S & KNOWSLEY TEACHING HOSPITALS NHS TRUST THE ASEPTIC DISPENSING UNIT (ADU), PHARMACY DEPARTMENT, WHISTON HOSPITAL, WARRINGTON ROAD, PRESCOT, UNITED KINGDOM, L35 5DR

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 126 of 147 Licence Holder MS 13523

STOCKPORT NHS FOUNDATION TRUST STEPPING HILL HOSPITAL, POPLAR GROVE, STOCKPORT, UNITED KINGDOM, SK2 7JE

SITE ID : 5566 STOCKPORT PHARMACEUTICALS PRODUCTION UNIT STEPPING HILL HOSPITAL, STOCKPORT, UNITED KINGDOM, SK2 7JE

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING INJECTIONS/VIALS MICRO ENEMAS PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING TABLETS

Licence Holder MS 33948

SUMMER HEALTHCARE LIMITED 4 PETRE ROAD, CLAYTON BUSINESS PARK, CLAYTON-LE-MOORS, ACCRINGTON, UNITED KINGDOM, BB5 5JB

SITE ID : 1905826 SUMMER HEALTHCARE LIMITED

4 PETRE ROAD, CLAYTON BUSINESS PARK, CLAYTON LE MOORS, ACCRINGTON, UNITED KINGDOM, BB5 5JB

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES AIRLINE KITS OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 127 of 147 Licence Holder MS 29985

SUPPLYVAX LIMITED 1 CHORLEY HALL LANE, ALDERLEY EDGE, UNITED KINGDOM, SK9 7EU

SITE ID : 8674153 SUPPLYVAX LIMITED 1 CHORLEY HALL LANE, ALDERLEY EDGE, UNITED KINGDOM, SK9 7EU

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 14704

SUREPHARM SERVICES LIMITED UNIT 2H BRETBY BUSINESS PARK, ASHBY ROAD EAST, BRETBY, BURTON ON TRENT, UNITED KINGDOM, DE15 0YZ

SITE ID : 5493 SUREPHARM SERVICES LIMITED UNIT 2H, BRETBY BUSINESS PARK, ASHBY ROAD EAST, BRETBY, BURTON-ON-TRENT, UNITED KINGDOM, DE15 0YZ

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES OTHER FOOD SUPPLEMENTS OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Licence Holder MS 3787

SWINGWARD LIMITED LYNSTOCK HOUSE, LYNSTOCK WAY, LOSTOCK, BOLTON, UNITED KINGDOM, BL6 4SA

SITE ID : 11532 MIDDLEBROOK LABORATORIES LYNSTOCK HOUSE, LYNSTOCK WAY, LOSTOCK, BOLTON, UNITED KINGDOM, BL6 4SA

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS

SITE ID : 36990 SWINGWARD LIMITED

LYNSTOCK HOUSE, LYNSTOCK WAY, LOSTOCK, BOLTON, UNITED KINGDOM, BL6 4SA

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS)

Date of Publication 01 August 2015 Human Only Page 128 of 147 Licence Holder MS 13928

SYNER-MED (PHARMACEUTICAL PRODUCTS) LIMITED SYNER-MED HOUSE, 120 HIGH STREET, PURLEY, UNITED KINGDOM, CR8 2AD

SITE ID : 10177065 SYNER-MED (PHARMACEUTICAL PRODUCTS) LIMITED SYNER-MED HOUSE, 120 HIGH STREET, PURLEY, UNITED KINGDOM, CR8 2AD

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 39307

SYRI LIMITED UNIT 4, BRADFIELD ROAD, RUISLIP, UNITED KINGDOM, HA4 0NU

SITE ID : 303632 SYRI LIMITED UNIT 4, BRADFIELD ROAD, RUISLIP, UNITED KINGDOM, HA4 0NU

Date of Publication 01 August 2015 Human Only Page 129 of 147 Licence Holder MS 11463

TAUNTON AND SOMERSET NHS FOUNDATION TRUST TAUNTON & SOMERSET HOSPITAL, MUSGROVE PARK, TAUNTON, UNITED KINGDOM, TA1 5DA

SITE ID : 305923 TAUNTON AND SOMERSET NHS FOUNDATION TRUST MEDICAL PHYSICS DEPARTMENT, RADIOPHARMACY UNIT, TAUNTON & SOMERSET HOSPITAL, MUSGROVE PARK, TAUNTON, UNITED KINGDOM, TA1 5DA

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS WE PERFORM OTHER CLINICAL PROCEDURES THAT INCLUDE THE SEPARATION AND BIOLOGICAL MEDICINAL PRODUCTS RE-ADMINISTRATION OF BLOOD PRODUCTS BUT NOT AS PART OF THE ACTIVITIES. THESE ARE DONE FOR NAMED PATIENTS WITHIN THE PREMISES.

OTHER NON-STERILE MEDICINAL PRODUCTS RADIOPHARMACEUTICAL SPECIALS, MOSTLY NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTC-99M DOSAGE BASED. FORMS) MANUFACTURE IN CLOSED PROCEDURES FOR PATIENTS AT TWO HOSPITALS.

PACKAGING ONLY PRIMARY PACKAGING TABLETS

Date of Publication 01 August 2015 Human Only Page 130 of 147 Licence Holder MS 14076

TAYSIDE HEALTH BOARD TAYSIDE PHARMACEUTICALS, TAYSIDE HEALTH BOARD, NINEWELLS HOSPITAL, DUNDEE, UNITED KINGDOM, DD1 9SY

SITE ID : 29642 TAYSIDE PHARMACEUTICALS

NINEWELLS HOSPITAL, DUNDEE, UNITED KINGDOM, DD1 9SY

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 35315

TEMAG PHARMA LIMITED BIO-PARK, BROADWATER ROAD, WELWYN GARDEN CITY, UNITED KINGDOM, AL7 3AX

SITE ID : 4486516 TEMAG PHARMA LIMITED BUILDING 34, BIO-PARK, BROADWATER ROAD, WELWYN GARDEN CITY, UNITED KINGDOM, AL7 3AX

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING TABLETS

Date of Publication 01 August 2015 Human Only Page 131 of 147 Licence Holder MS 21538

TERUMO BCT LIMITED OLD BELFAST ROAD, MILLBROOK, LARNE, UNITED KINGDOM, BT40 2SH

SITE ID : 21804 TERUMO BCT LIMITED OLD BELFAST ROAD, MILLBROOK, LARNE, UNITED KINGDOM, BT40 2SH

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS TERMINALLY STERILISED LARGE VOLUME LIQUIDS TERMINALLY STERILISED SMALL VOLUME LIQUIDS

Licence Holder MS 32390

THERMO ELECTRON LIMITED 3RD FLOOR, 1 ASHLEY ROAD, ALTRINCHAM, UNITED KINGDOM, WA14 2DT

SITE ID : 411870 THERMO FISHER SCIENTIFIC THERMO FISHER SCIENTIFIC, FISHER BIOSERVICES DIVISION, UNIT 1, WOODSIDE, DUNMOW ROAD, BIRCHANGER, BISHOP'S STORTFORD, UNITED KINGDOM, CM23 5RG

NON-STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS NON-STERILE PRODUCTS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS TERMINALLY STERILISED PRODUCTS

Licence Holder MS 15957

THE ROYAL WOLVERHAMPTON NHS TRUST NEW CROSS HOSPITAL, WEDNESFIELD ROAD, WOLVERHAMPTON, UNITED KINGDOM, WV10 0QP

SITE ID : 7348 THE ROYAL WOLVERHAMPTON NHS TRUST NEW CROSS HOSPITAL, WEDNESFIELD ROAD, WOLVERHAMPTON, UNITED KINGDOM, WV10 0QP

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGPREPARATION DOSAGE FORMS)AND DISPENSING OF RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Human Only Page 132 of 147 Licence Holder MS 17661

THE SPECIALS LABORATORY LIMITED UNITS 1, 2 AND 3 REGENTS DRIVE, LOW PRUDHOE INDUSTRIAL ESTATE, PRUDHOE, UNITED KINGDOM, NE42 6PX

SITE ID : 714421 THE SPECIALS LABORATORY LIMITED

UNITS 1, 2 AND 3 REGENTS DRIVE, LOW PRUDHOE INDUSTRIAL ESTATE, PRUDHOE, UNITED KINGDOM, NE42 6PX

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, HARD SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS OINTMENTS, CREAMS, EMULSIONS, EAR DROPS, LOTIONS, PAINTS, APPLICATIONS, MEDICINAL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SHAMPOOS, NASAL DROPS SUSPENSIONS, MOUTHWASHES/GARGLES, DISINFECTANS, REEFERS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SUPPOSITORIES SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS CAPSULES, HARD SHELL SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS SUPPOSITORIES UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS

OTHER MANUFACTURING/IMPORT ACTIVITIES OTHER PENICILLINS, CEPHALOSPORINS, CYTOSTATICS/CYTOTOXICS, OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 240

THORNTON & ROSS LIMITED LINTHWAITE, HUDDERSFIELD, UNITED KINGDOM, HD7 5QH

SITE ID : 14497 THORNTON & ROSS LIMITED LINTHWAITE, HUDDERSFIELD, UNITED KINGDOM, HD7 5QH

OTHER NON-STERILE MEDICINAL PRODUCTS PACKAGING ONLY PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING TABLETS

Date of Publication 01 August 2015 Human Only Page 133 of 147 Licence Holder MS 20848

THORPE LABORATORIES LIMITED GOLF ROAD INDUSTRIAL ESTATE, MABLETHORPE, UNITED KINGDOM, LN12 1NB

SITE ID : 13984 THORPE LABORATORIES LIMITED GOLF ROAD INDUSTRIAL ESTATE, MABLETHORPE, UNITED KINGDOM, LN12 1NB

PACKAGING ONLY PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Licence Holder MS 39

UCB PHARMA LIMITED 208 BATH ROAD, SLOUGH, UNITED KINGDOM, SL1 3WE

SITE ID : 25203 UCB PHARMA LIMITED 208 BATH ROAD, SLOUGH, UNITED KINGDOM, SL1 3WE

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 31610

U L MEDICINES LIMITED UNIT 3D, REGAL WAY, WATFORD, UNITED KINGDOM, WD24 4YJ

SITE ID : 1125963 U L MEDICINES LIMITED UNIT 3D, REGAL WAY, WATFORD, UNITED KINGDOM, WD24 4YJ

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 134 of 147 Licence Holder MS 18631

UNITED LINCOLNSHIRE HOSPITAL NHS TRUST DEPT OF MEDICAL PHYSICS, LINCOLN HOSPITAL, GREETWELL ROAD, LINCOLN, UNITED KINGDOM, LN2 5QY

SITE ID : 11126 UNITED LINCOLNSHIRE HOSPITAL NHS TRUST DEPT OF MEDICAL PHYSICS, LINCOLN HOSPITAL, GREETWELL ROAD, LINCOLN, UNITED KINGDOM, LN2 5QY

RADIOPHARMACEUTICALS/RADIONUCLIDE PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES GENERATORS

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 17022

UNIVERSITY COLLEGE LONDON HOSPITALS NHS FOUNDATION TRUST TRUST HEADQUARTERS, 2ND FLOOR CENTRAL, 250 EUSTON ROAD, LONDON, UNITED KINGDOM, NW1 2PQ

SITE ID : 4807458 UNIVERSITY COLLEGE LONDON HOSPITALS NHS FOUNDATION TRUST UNIT 14, BREWERY ROAD, LONDON, UNITED KINGDOM, N7 9NH

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING CHEWING GUMS PRIMARY PACKAGING IMPREGNATED MATRICES PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING ANY OTHER PRODUCTS REQUIRED FOR PACKING UNDER MIA(IMP) PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING PRESSURISED PREPARATIONS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS PRIMARY PACKAGING TRANSDERMAL PATCHES

Date of Publication 01 August 2015 Human Only Page 135 of 147 Licence Holder MS 12893

UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST THE PHARMACY, BRISTOL ROYAL INFIRMARY, MAUDLIN STREET, BRISTOL, UNITED KINGDOM, BS2 8HW

SITE ID : 27237 UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST - RADIOPHARMACY UNIT MARLBOROUGH STREET, BRISTOL, UNITED KINGDOM, BS2 8HW

SITE ID : 117868 UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST BRISTOL ROYAL INFIRMARY, MARLBOROUGH STREET, BRISTOL, UNITED KINGDOM, BS2 8HW

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE SOFT FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS)

Licence Holder MS 13268

UNIVERSITY HOSPITALS COVENTRY & WARWICKSHIRE NHS TRUST CLIFFORD BRIDGE ROAD, COVENTRY, UNITED KINGDOM, CV2 2DX

SITE ID : 27595 UNIVERSITY HOSPITALS COVENTRY & WARWICKSHIRE NHS TRUST - PHARMACY DEPARTMENT CLIFFORD BRIDGE ROAD, COVENTRY, UNITED KINGDOM, CV2 2DX

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

SITE ID : 90526 UNIVERSITY HOSPITALS COVENTRY & WARWICKSHIRE NHS TRUST - DEPARTMENT OF NUCLEAR MEDICINE CLIFFORD BRIDGE ROAD, WALSGRAVE HOSPITAL, COVENTRY, UNITED KINGDOM, CV2 2DX

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) OTHER ASEPTICALLY PREPARED PRODUCTS RADIOPHARMACEUTICALS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 136 of 147 Licence Holder MS 21275

UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST RADIOPHARMACY, DEPARTMENT OF MEDICAL PHYSICS, SANDRINGHAM BUILDING, LEICESTER ROYAL INFIRMARY, LEICESTER, UNITED KINGDOM, LE1 5WW

SITE ID : 372277 UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST RADIOPHARMACY, DEPARTMENT OF MEDICAL PHYSICS, SANDRINGHAM BUILDING, LEICESTER ROYAL INFIRMARY, LEICESTER, UNITED KINGDOM, LE1 5WW

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS IMMUNOLOGICAL PRODUCTS

BIOLOGICAL MEDICINAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS Y-90 LABELLED IBRITUMOMAB TIUXETAN (ZEVALIN)

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS RADIOACTIVE MATERIALS INCLUDING SOLID, NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUID DOSAGE AND SEMI-SOLID FORMS) MEALS FOR NUCLEAR MEDICINE INVESTIGATIONS/TREATMENT. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS)

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS, INCLUDING PARENTERALS AND EYE-DROPS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 16998

UNIVERSITY HOSPITALS OF MORECAMBE BAY NHS FOUNDATION TRUST NUCLEAR MEDICINE DEPARTMENT, FURNESS GENERAL HOSPITAL, DALTON LANE, BARROW-IN-FURNESS, UNITED KINGDOM, LA14 4LF

SITE ID : 21979 UNIVERSITY HOSPITALS OF MORECAMBE BAY NHS FOUNDATION TRUST X-RAY DEPARTMENT, FURNESS GENERAL HOSPITAL, DALTON LANE, BARROW-IN-FURNESS, UNITED KINGDOM, LA14 4LF

PACKAGING ONLY PRIMARY PACKAGING LIQUIDS FOR EXTERNAL USE PRIMARY PACKAGING LIQUIDS FOR INTERNAL USE

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 137 of 147 Licence Holder MS 33937

UNIVERSITY HOSPITALS OF MORECAMBE BAY NHS TRUST (PHARMACY DEPARTMENT RLI) PHARMACY DEPARTMENT, ROYAL LANCASTER INFIRMARY, ASHTON ROAD, LANCASTER, UNITED KINGDOM, LA1 4RP

SITE ID : 603432 ASEPTIC SERVICES UNIT - ROYAL LANCASTER INFIRMARY PHARMACY DEPARTMENT, ROYAL LANCASTER INFIRMARY, ASHTON ROAD, LANCASTER, UNITED KINGDOM, LA1 4RP

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS OTHER BIOLOGICAL MEDICINAL PRODUCTS MONOCLONAL ANTIBODY PREPARATIONS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

Licence Holder MS 13780

UNIVERSITY HOSPITALS OF NORTH MIDLANDS NHS TRUST ROYAL STOKE UNIVERSITY HOSPITAL, NEWCASTLE ROAD, STOKE-ON-TRENT, UNITED KINGDOM, ST4 6QG

SITE ID : 354459 UNIVERSITY HOSPITALS OF NORTH MIDLANDS NHS TRUST - DEPARTMENT OF NUCLEAR MEDICINE IMAGING DEPARTMENT, MAIN BUILDING, ROYAL STOKE UNIVERSITY HOSPITAL, NEWCASTLE ROAD, STOKE ON TRENT, UNITED KINGDOM, ST4 6QG

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGRADIO DOSAGE ACTIVE DIAGNOSTICFORMS) AGENTS FOR INJECTION AND INHALATION ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 6803879 UNIVERSITY HOSPITALS OF NORTH MIDLANDS NHS TRUST PHARMACY DIRECTORATE, MAIN BUILDING, ROYAL STOKE UNIVERSITY HOSPITAL, NEWCASTLE ROAD, STOKE-ON-TRENT, UNITED KINGDOM, ST4 6QG

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICS ARE HANDLED EG.MONOCLONAL ANTIBODIES. THESE ARE PRODUCTS HANDLED

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS ACUTE HOSPITAL MAY BE REQUIRED TO PREPARE UNUSUAL DOSAGE FORMS. WIDE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGRANGE DOSAGE OF DERMATOLOGICALS FORMS) PREPARED. ALSO INCLUDES PRIMARY PACKAGING OF SOFT SHELL CAPSULES AND TABLETS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS)

Date of Publication 01 August 2015 Human Only Page 138 of 147 Licence Holder MS 11709

UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST RADIOPHARMACY, NUCLEAR MEDICINE DEPT, TREMONA ROAD, SOUTHAMPTON, UNITED KINGDOM, SO16 6YD

SITE ID : 22528 UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST RADIOPHARMACY, NUCLEAR MEDICINE DEPT, TREMONA ROAD, SOUTHAMPTON, UNITED KINGDOM, SO16 6YD

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 21761

UNIVERSITY OF BIRMINGHAM CELL THERAPY FACILITY, ADVANCED THERAPIES FACILITY, WOLFSON DRIVE, EDGBASTON, BIRMINGHAM, UNITED KINGDOM, B15 2TT

SITE ID : 9098525 UNIVERSITY OF BIRMINGHAM CELL THERAPY FACILITY, ADVANCED THERAPIES FACILITY, WOLFSON DRIVE, EDGBASTON, BIRMINGHAM, UNITED KINGDOM, B15 2TT

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BLOOD PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS

OTHER STORAGE OF PRODUCT IN CRYOBAGS PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES AND CRYOVIALS

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE ASEPTICALLY FORMS) PREPARED PRODUCTS TISSUE ENGINEERED PRODUCTS

Licence Holder MS 3830

UNIVERSITY OF CAMBRIDGE BOX 65, ADDENBROOKE'S HOSPITAL, HILLS ROAD, CAMBRIDGE, UNITED KINGDOM, CB2 2QQ

SITE ID : 121190 WOLFSON BRAIN IMAGING CENTRE DEPARTMENT OF CLINICAL NEUROSCIENCES BOX 65, ADDENBROOKE'S HOSPITAL, HILLS ROAD, CAMBRIDGE, UNITED KINGDOM, CB2 2QQ

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) MEDICINAL GASES SOLID NON-STERILE DOSAGE FORMS MEDICINAL GASES

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 139 of 147 Licence Holder MS 1384

UNIVERSITY OF EDINBURGH THE UNIVERSITY COURT OF THE UNIVERSITY OF EDINBURGH, OLD COLLEGE, SOUTH BRIDGE, EDINBURGH, UNITED KINGDOM, EH8 9YL

SITE ID : 305937 UNIVERSITY OF EDINBURGH - PET RADIOCHEMISTRY QUEENS MEDICAL RESEARCH INSTITUTE, 47 LITTLE FRANCE CRESCENT, EDINBURGH, UNITED KINGDOM, EH16 4TJ

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES RADIOPHARMACEUTICALS/RADIONUCLIDE GENERATORS UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

SITE ID : 7203285 UNIVERSITY OF EDINBURGH - INVESTIGATIONAL SUPPLIES GROUP 1 GEORGE SQUARE, EDINBURGH, UNITED KINGDOM, EH8 9JZ

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL OTHER NON-STERILE MEDICINAL PRODUCTS PRIMARY PACKAGING POWDERS PRIMARY PACKAGING SUPPOSITORIES PRIMARY PACKAGING TABLETS

Date of Publication 01 August 2015 Human Only Page 140 of 147 Licence Holder MS 35030

UNIVERSITY OF MANCHESTER OXFORD ROAD, MANCHESTER, UNITED KINGDOM, M13 9PL

SITE ID : 107664 WOLFSON MOLECULAR IMAGING CENTRE WOLFSON MOLECULAR IMAGING CENTRE, 27 PALATINE ROAD, MANCHESTER, UNITED KINGDOM, M20 3LJ

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 2459992 UNIVERSITY OF MANCHESTER CLEANROOM FACILITY UNIT G27, GROUND FLOOR, CORE TECHNOLOGY FACILITY, 46 GRAFTON STREET, MANCHESTER, UNITED KINGDOM, M13 9NT

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CELL THERAPY PRODUCTS BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

OTHER ASEPTICALLY PREPARED PRODUCTS STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGDECELLULARISED DOSAGE FORMS) HUMAN TISSUE ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Licence Holder MS 18739

UNIVERSITY OF SHEFFIELD ACADEMIC UNIT OF RADIOLOGY, C FLOOR, DIVISION OF CLINICAL SCIENCES, ROYAL HALLAMSHIRE HOSPITAL, GLOSSOP ROAD, SHEFFIELD, UNITED KINGDOM, S10 2JF

SITE ID : 114966 UNIVERSITY OF SHEFFIELD ACADEMIC UNIT OF RADIOLOGY, C FLOOR, DIVISION OF CLINICAL SCIENCES, ROYAL HALLAMSHIRE HOSPITAL, GLOSSOP ROAD, SHEFFIELD, UNITED KINGDOM, S10 2JF

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGMEDICINAL DOSAGE GASES FORMS)

PACKAGING ONLY PRIMARY PACKAGING MEDICINAL GASES

Date of Publication 01 August 2015 Human Only Page 141 of 147 Licence Holder MS 32879

VERTICAL PHARMA RESOURCES LIMITED 41 CENTRAL AVENUE, WEST MOLESEY, UNITED KINGDOM, KT8 2QZ

SITE ID : 93706 VERTICAL PHARMA RESOURCES LIMITED 41 CENTRAL AVENUE, WEST MOLESEY, UNITED KINGDOM, KT8 2QZ

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS MANUFACTURE OF "SPECIALS" EXTEMPORANEOUS PREPARATIONS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWING(EXCLUDING DOSAGE STERILES) FORMS) IN ALL FORMS (INCLUDING POWDERS), STRENGTH AND QUALITY, PRIMARY PACKAGING. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 1411

WASDELL PACKAGING LIMITED UNITS 1, 2, 3, 5, 6, 7 & 8 EURO WAY INDUSTRIAL ESTATE, BLAGROVE, SWINDON, UNITED KINGDOM, SN5 8YW

SITE ID : 1767214 WASDELL PACKAGING LIMITED

UNITS 1, 2, 3, 5, 6, 7 & 8 EURO WAY INDUSTRIAL ESTATE, BLAGROVE, SWINDON, UNITED KINGDOM, SN5 8YW

Date of Publication 01 August 2015 Human Only Page 142 of 147 Licence Holder MS 6464

WAYMADE PLC REGENCY HOUSE, MILES GRAY ROAD, BASILDON, UNITED KINGDOM, SS14 3AF

SITE ID : 3189832 WAYMADE PLC SOVEREIGN SPECIALS, REGENCY HOUSE, MILES GRAY ROAD, BASILDON, UNITED KINGDOM, SS14 3RW

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE SOFT FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGPOWDERS, DOSAGE PESSARIES, FORMS) EAR-DROPS. NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGTABLETS DOSAGE FORMS)

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING TABLETS PRIMARY PACKAGING TRANSDERMAL PATCHES

Date of Publication 01 August 2015 Human Only Page 143 of 147 Licence Holder MS 298

WELEDA UK LIMITED HEANOR ROAD, ILKESTON, DERBY, UNITED KINGDOM, DE7 8DR

SITE ID : 14669 WELEDA (UK) LIMITED HEANOR ROAD, ILKESTON, DERBY, UNITED KINGDOM, DE7 8DR

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OINTMENTS, CREAMS, GELS, PASTES, PAINTS, OILS. NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) TABLETS SEMI-SOLID AND OTHER LIQUID NON-STERILE DOSAGE FORMS SEMI-SOLIDS SOLID NON-STERILE DOSAGE FORMS OTHER SOLID DOSAGE FORMS SOLID NON-STERILE DOSAGE FORMS TABLETS UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING SUPPOSITORIES

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS OTHER 1.COATING OF UNIT DOSE SOLIDS, 2.PRODUCTION OF UNIT DOSE AND MULTIPLE OTHER MANUFACTURING/IMPORT ACTIVITIES DOSE POWDERS, 3.PREPARATION OF HERBAL MIXTURES FOR INFUSION FOR ORAL USE & EXTERNAL USE AS A COMPRESS. UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 33876

WESTERN HEALTH AND SOCIAL CARE TRUST PHARMACY DEPARTMENT, ALTNAGELVIN AREA HOSPITAL, GLENSHANE ROAD, LONDONDERRY, UNITED KINGDOM, BT47 6SB

SITE ID : 817524 WESTERN HEALTH AND SOCIAL CARE TRUST PHARMACY DEPARTMENT, ALTNAGELVIN AREA HOSPITAL, GLENSHANE ROAD, LONDONDERRY, UNITED KINGDOM, BT47 6SB

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING TABLETS

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Human Only Page 144 of 147 Licence Holder MS 18300

WEST HERTFORDSHIRE HOSPITALS NHS TRUST PHARMACY DEPARTMENT, AAU LEVEL 2, VICARAGE ROAD, WATFORD, UNITED KINGDOM, WD18 0HB

SITE ID : 922136 WATFORD GENERAL HOSPITAL PHARMACY DEPARTMENT, TECHNICAL SERVICES, AAU LEVEL 2, VICARAGE ROAD, WATFORD, UNITED KINGDOM, WD18 0HB

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CYTOSTATICS/CYTOTOXICS.

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR EXTERNAL USE NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) LIQUIDS FOR INTERNAL USE

NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER NON-STERILE MEDICINAL PRODUCTS TOPICAL CREAMS AND OINTMENTS. UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR EXTERNAL USE UNIT AND MULTI-DOSE NON-STERILE LIQUIDS LIQUIDS FOR INTERNAL USE

PACKAGING ONLY PRIMARY PACKAGING CAPSULES, HARD SHELL PRIMARY PACKAGING CAPSULES, SOFT SHELL PRIMARY PACKAGING OTHER SOLID DOSAGE FORMS PRIMARY PACKAGING SEMI-SOLIDS PRIMARY PACKAGING TABLETS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MS 13556

WIRRAL UNIVERSITY TEACHING HOSPITAL NHS FOUNDATION TRUST ARROWE PARK ROAD, PHARMACY DEPARTMENT, ARROWE PARK HOSPITAL, UPTON, WIRRAL, UNITED KINGDOM, CH49 5PE

SITE ID : 90581 ASEPTIC MANUFACTURING UNIT WIRRAL UNIVERSITY TEACHING HOSPITAL NHS FOUNDATION TRUST ARROWE PARK ROAD, PHARMACY DEPARTMENT, ARROWE PARK HOSPITAL, WIRRAL, UNITED KINGDOM, CH49 5PE

Date of Publication 01 August 2015 Human Only Page 145 of 147 Licence Holder MS 20009

WYTHENSHAWE HOSPITAL PHARMACY ASEPTIC SERVICES, SOUTHMOOR ROAD, MANCHESTER, UNITED KINGDOM, M23 9LT

SITE ID : 12928 WYTHENSHAWE HOSPITAL PHARMACY ASEPTIC SERVICES, SOUTHMOOR ROAD, MANCHESTER, UNITED KINGDOM, M23 9LT

OTHER BIOLOGICAL MEDICINAL PRODUCTS TOTAL PARENTERAL NUTRITION POLYMIXES AMINOLYCOSIDES ANTI FUNGALS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS POTASSIUM CHLORIDE SOLUTIONS EPOPROSTENOL BETA-LACTARS E.G. AZTREONAM MACROLIDES VANCO

Licence Holder MS 42563

YOURWAY TRANSPORT LIMITED 8 STONEYFIELD, GERRARDS CROSS, UNITED KINGDOM, SL9 7LU

SITE ID : 8641729 YOURWAY TRANSPORT LIMITED 2 PULBOROUGH WAY, HOUNSLOW, UNITED KINGDOM, TW4 6DE

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MS 25595

ZOOBIOTIC LIMITED UNITS 2-4 DUNRAVEN BUSINESS PARK, COYCHURCH ROAD, BRIDGEND, UNITED KINGDOM, CF31 3BG

SITE ID : 120642 ZOOBIOTIC LIMITED UNITS 2-4 DUNRAVEN BUSINESS PARK, COYCHURCH ROAD, BRIDGEND, UNITED KINGDOM, CF31 3BG

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS LARVAE OF LUCILIA SERICATA (GREENBOTTLE FLY MAGGOTS)

OTHER NON-STERILE MEDICINAL PRODUCTS DISINFECTED LARVAE OF LUCILIA SERICATA AS NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGFREE RANGEDOSAGE "LARVAE", FORMS) BIOFOAM AND BIOFOAM MAINTENANCE DRESSINGS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Human Only Page 146 of 147 Licence Holder MS 3811

ZOOLOGICAL SOCIETY OF LONDON ZSL LONDON ZOO, REGENT'S PARK, LONDON, UNITED KINGDOM, NW1 4RY

SITE ID : 15073 ZOOLOGICAL SOCIETY OF LONDON ZSL LONDON ZOO, REGENT'S PARK, LONDON, UNITED KINGDOM, NW1 4RY

UNLICENSED MEDICINAL PRODUCTS ARE PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Date of Publication 01 August 2015 Human Only Page 147 of 147

SECTION 2 – VETERINARY

Date of Publication: 01 August 2015 Register of Licensed Manufacturing Sites (Veterinary)

Licence Holder MANSA 5977

AINSWORTHS (LONDON) LIMITED 40-44 HIGH STREET, CATERHAM, UNITED KINGDOM, CR3 5UB

SITE ID : 16822 AINSWORTHS (LONDON) LIMITED 40-44 HIGH STREET, CATERHAM, UNITED KINGDOM, CR3 5UB

Licence Holder MANSA 20377

ALMAC CLINICAL SERVICES LIMITED 9 CHARLESTOWN ROAD, SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, UNITED KINGDOM, BT63 5PW

SITE ID : 13423 ALMAC CLINICAL SERVICES LIMITED SEAGOE INDUSTRIAL ESTATE, 9 CHARLESTOWN ROAD, CRAIGAVON, UNITED KINGDOM, BT63 5PW

STERILE PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS ASEPTICALLY PREPARED PRODUCTS BATCH CERTIFICATION OF IMPORTED MEDICINAL PRODUCTS TERMINALLY STERILISED PRODUCTS

Date of Publication 01 August 2015 Veterinary Only Page 1 of 13 Licence Holder MANSA 11724

ANDERSONBRECON (UK) LIMITED PHAROS HOUSE, WYE VALLEY BUSINESS PARK, BRECON PARK, BRECON ROAD, HAY-ON-WYE, HEREFORD, UNITED KINGDOM, HR3 5PG

SITE ID : 114445 ANDERSONBRECON (UK) LIMITED

UNITS 2-7, WYE VALLEY BUSINESS PARK, BRECON ROAD, HAY-ON-WYE, HEREFORD, UNITED KINGDOM, HR3 5PG

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Veterinary Only Page 2 of 13 Licence Holder MANSA 116

BAXTER HEALTHCARE LIMITED CAXTON WAY, THETFORD, UNITED KINGDOM, IP24 3SE

SITE ID : 18507 BAXTER HEALTHCARE LIMITED CAXTON WAY, THETFORD, UNITED KINGDOM, IP24 3SE

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS ANTIVIRALS, NON-CYTOTOXIC AND CYTOTOXIC MONOCLONAL ANTIBODIES

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGCYTOTOXICS, DOSAGE PENICILLINS FORMS) AND CEPHALOSPORINS ASEPTICALLY PREPARED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

SITE ID : 28970 ASEPTIC COMPOUNDING UNIT, MOUNT VERNON HOSPITAL RICKMANSWORTH ROAD, NORTHWOOD, UNITED KINGDOM, HA6 2RN

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS NON-CYTOTOXIC AND CYTOTOXIC MONOCLONAL ANTIBODIES

SITE ID : 90119 BAXTER HEALTHCARE LIMITED HEATON CHAPEL, UNIT 1, BOUNDARY COURT, CROSSLEY ROAD, STOCKPORT, UNITED KINGDOM, SK4 5GA

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS NON-CYTOTOXIC AND CYTOTOXIC MONOCLONAL ANTIBODIES

SITE ID : 525104 BAXTER HEALTHCARE LIMITED

UNIT B, TAURUS BUILDING, PETERLEY ROAD, COWLEY, OXFORD, UNITED KINGDOM, OX4 2TZ

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS NON-CYTOTOXIC AND CYTOTOXIC MONOCLONAL ANTIBODIES

Date of Publication 01 August 2015 Veterinary Only Page 3 of 13 Licence Holder MANSA 34777

BCM SPECIALS LIMITED 1 THANE ROAD WEST, NOTTINGHAM, UNITED KINGDOM, NG2 3AA

SITE ID : 120399 BCM LIMITED THANE ROAD, BEESTON, NOTTINGHAM, UNITED KINGDOM, NG90 2PR

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS HUMAN OR ANIMAL EXTRACTED PRODUCTS

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGCAPSULES, DOSAGE HARD FORMS) SHELL NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR EXTERNAL FORMS) USE NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGLIQUIDS DOSAGE FOR INTERNAL FORMS) USE OTHER NON-STERILE MEDICINAL PRODUCTS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGPOWDERS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGOTHER DOSAGE SOLID DOSAGE FORMS) FORMS NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) NON-STERILE PRODUCTS (PROCESSING OPERATIONS FOR THE FOLLOWINGSUPPOSITORIES DOSAGE FORMS)

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING

Licence Holder MANSA 123

DALES PHARMACEUTICALS LIMITED SNAYGILL INDUSTRIAL ESTATE, KEIGHLEY ROAD, SKIPTON, UNITED KINGDOM, BD23 2RW

SITE ID : 2904 DALES PHARMACEUTICALS LIMITED SNAYGILL INDUSTRIAL ESTATE, KEIGHLEY ROAD, SKIPTON, UNITED KINGDOM, BD23 2RW

STERILE PRODUCTS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGLARGE DOSAGE VOLUME FORMS) LIQUIDS TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSEMI-SOLIDS DOSAGE FORMS) TERMINALLY STERILISED (PROCESSING OPERATIONS FOR THE FOLLOWINGSMALL DOSAGE VOLUME FORMS) LIQUIDS

Date of Publication 01 August 2015 Veterinary Only Page 4 of 13 Licence Holder MANSA 3537

DR S B KAYNE BUSBY PHARMACY, 20 MAIN STREET, CLARKSTON, GLASGOW, UNITED KINGDOM, G76 8DU

SITE ID : 92159 FREEMAN'S HOMEOPATHIC PHARMACY BUSBY PHARMACY, 20 MAIN STREET, CLARKSTON, GLASGOW, UNITED KINGDOM, G76 8DU

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS

Licence Holder MANSA 4321

DURBIN PLC 180 NORTHOLT ROAD, HARROW, UNITED KINGDOM, HA2 0LT

SITE ID : 31307 DURBIN PLC 180 NORTHOLT ROAD, HARROW, UNITED KINGDOM, HA2 0LT

SITE ID : 92333 DURBIN PLC 19 FAIRWAY DRIVE, GREENFORD, UNITED KINGDOM, UB6 8PW

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS

SITE ID : 936068 DURBIN PLC 12 FAIRWAY DRIVE, GREENFORD, UNITED KINGDOM, UB6 8PW

Date of Publication 01 August 2015 Veterinary Only Page 5 of 13 Licence Holder MANSA 4515

HOSPIRA UK LIMITED 732-735, TUDOR ESTATE, ABBEY ROAD, PARK ROYAL, LONDON, UNITED KINGDOM, NW10 7UN

SITE ID : 8832 HOSPIRA ASEPTIC SERVICES LIMITED 732-735, TUDOR ESTATE, ABBEY ROAD, PARK ROYAL, LONDON, UNITED KINGDOM, NW10 7UN

Licence Holder MANSA 33634

ITH PHARMA LIMITED UNIT 4, PREMIER PARK, PREMIER PARK ROAD, LONDON, UNITED KINGDOM, NW10 7NZ

SITE ID : 544699 ITH PHARMA LIMITED UNIT 4, PREMIER PARK, PREMIER PARK ROAD, LONDON, UNITED KINGDOM, NW10 7NZ

BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS BIOTECHNOLOGY PRODUCTS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Licence Holder MANSA 15184

LEXON (UK) LIMITED UNIT 18, OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, UNITED KINGDOM, B98 0RE

SITE ID : 6246 LEXON (UK) LIMITED UNIT 18, OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, UNITED KINGDOM, B98 0RE

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Veterinary Only Page 6 of 13 Licence Holder MANSA 156

MARTINDALE PHARMACEUTICALS LIMITED BAMPTON ROAD, HAROLD HILL, ROMFORD, UNITED KINGDOM, RM3 8UG

SITE ID : 6838 MARTINDALE PHARMACEUTICALS LIMITED HUBERT ROAD, BRENTWOOD, UNITED KINGDOM, CM14 4JY

Date of Publication 01 August 2015 Veterinary Only Page 7 of 13 Licence Holder MANSA 2000

NORBROOK LABORATORIES LIMITED STATION WORKS, CAMLOUGH ROAD, NEWRY, UNITED KINGDOM, BT35 6JP

SITE ID : 12918 STATION WORKS STATION WORKS, CAMLOUGH ROAD, NEWRY, UNITED KINGDOM, BT35 6JP

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CORTICOSTEROIDS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

SITE ID : 12919 ARMAGH ROAD SITE 105 ARMAGH ROAD, NEWRY, UNITED KINGDOM, BT35 6PU

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS CORTICOSTEROIDS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Veterinary Only Page 8 of 13 SITE ID : 89419 NORBROOK LABORATORIES LIMITED FACTORY NO 4, CARNBANE INDUSTRIAL ESTATE, NEWRY, UNITED KINGDOM, BT35 6QQ

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS PENICILLINS, CEPHALOSPORINS, CORTOCOSTEROIDS, HORMONES.

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SEMI-SOLIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS TERMINALLY STERILISED LARGE VOLUME LIQUIDS OTHER TERMINALLY STERILISED PREPARED TERMINALLY STERILISED PRODUCTS TERMINALLY STERILISED SEMI-SOLIDS TERMINALLY STERILISED SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Veterinary Only Page 9 of 13 Licence Holder MANSA 13581

NOVA LABORATORIES LIMITED MARTIN HOUSE, GLOUCESTER CRESCENT, WIGSTON, LEICESTER, UNITED KINGDOM, LE18 4YL

SITE ID : 4097 NOVA LABORATORIES LIMITED MARTIN HOUSE, GLOUCESTER CRESCENT, WIGSTON, LEICESTER, UNITED KINGDOM, LE18 4YL

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Licence Holder MANSA 13163

PACKPHARM LIMITED UNIT 14D, WENDOVER ROAD, RACKHEATH INDUSTRIAL ESTATE, RACKHEATH, NORWICH, UNITED KINGDOM, NR13 6LH

SITE ID : 8515 PACKPHARM LIMITED UNIT 14D, WENDOVER ROAD, RACKHEATH INDUSTRIAL ESTATE, RACKHEATH, NORWICH, UNITED KINGDOM, NR13 6LH

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) OTHER SOLID DOSAGE FORMS

PROCESSES/ACTIVITIES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY OF PARALLEL IMPORTED PRODUCTS OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT

Date of Publication 01 August 2015 Veterinary Only Page 10 of 13 Licence Holder MANSA 4351

PENN PHARMACEUTICAL SERVICES LIMITED UNITS 23-24, TAFARNAUBACH INDUSTRIAL ESTATE, TAFARNAUBACH, TREDEGAR, UNITED KINGDOM, NP22 3AA

SITE ID : 15302 PENN PHARMACEUTICAL SERVICES LIMITED

UNITS 23-24, TAFARNAUBACH INDUSTRIAL ESTATE, TAFARNAUBACH, TREDEGAR, UNITED KINGDOM, NP22 3AA

Licence Holder MANSA 11560

ROYAL SURREY COUNTY HOSPITAL NHS FOUNDATION TRUST EGERTON ROAD, GUILDFORD, UNITED KINGDOM, GU2 7XX

SITE ID : 23362 PHARMACY ASEPTIC SERVICES DEPT. PHARMACY DEPARTMENT, ROYAL SURREY COUNTY HOSPITAL, EGERTON ROAD, GUILDFORD, UNITED KINGDOM, GU2 7XX

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS MONOCLONAL ANTIBODIES USING CLOSED SYSTEMS

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) LARGE VOLUME LIQUIDS OTHER ASEPTICALLY PREPARED PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) PENICILLINS, CYTOTOXICS, CEPHALOSPORINS USING CLOSED SYSTEMS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Veterinary Only Page 11 of 13 Licence Holder MANSA 17661

THE SPECIALS LABORATORY LIMITED UNITS 1, 2 AND 3 REGENTS DRIVE, LOW PRUDHOE INDUSTRIAL ESTATE, PRUDHOE, UNITED KINGDOM, NE42 6PX

SITE ID : 714421 THE SPECIALS LABORATORY LIMITED

UNITS 1, 2 AND 3 REGENTS DRIVE, LOW PRUDHOE INDUSTRIAL ESTATE, PRUDHOE, UNITED KINGDOM, NE42 6PX

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS

OTHER MANUFACTURING/IMPORT ACTIVITIES OTHER PENICILLINS, CYTOSTATICS/CYTOTOXICS, HORMONES OTHER SPECIFIC PROCESSES/ACTIVITIES ASSEMBLY FOR EXPORT OTHER SPECIFIC PROCESSES/ACTIVITIES BULK OR PARTIAL MANUFACTURING OTHER SPECIFIC PROCESSES/ACTIVITIES MANUFACTURE AND ASSEMBLY FOR EXPORT UNLICENSED MEDICINAL PRODUCTS ARE OTHER SPECIFIC PROCESSES/ACTIVITIES IMPORTED FROM OUTSIDE THE EEA AT THIS SITE.

Licence Holder MANSA 11709

UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST RADIOPHARMACY, NUCLEAR MEDICINE DEPT, TREMONA ROAD, SOUTHAMPTON, UNITED KINGDOM, SO16 6YD

SITE ID : 22528 RADIOPHARMACY RADIOPHARMACY, NUCLEAR MEDICINE DEPT, TREMONA ROAD, SOUTHAMPTON, UNITED KINGDOM, SO16 6YD

OTHER BIOLOGICAL MEDICINAL PRODUCTS BIOLOGICAL/ACTIVES BIOLOGICAL MEDICINAL PRODUCTS ANTIBODIES

NON-STERILE PRODUCTS NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) CAPSULES, SOFT SHELL NON-STERILE PRODUCTS (LIST OF DOSAGE FORMS) SEMI-SOLIDS

STERILE PRODUCTS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SEMI-SOLIDS ASEPTICALLY PREPARED (LIST OF DOSAGE FORMS) SMALL VOLUME LIQUIDS TERMINALLY STERILISED SMALL VOLUME LIQUIDS

Date of Publication 01 August 2015 Veterinary Only Page 12 of 13 Licence Holder MANSA 298

WELEDA UK LIMITED HEANOR ROAD, ILKESTON, DERBY, UNITED KINGDOM, DE7 8DR

SITE ID : 14669 WELEDA (UK) LIMITED HEANOR ROAD, ILKESTON, DERBY, UNITED KINGDOM, DE7 8DR

PROCESSES/ACTIVITIES OTHER MANUFACTURING/IMPORT ACTIVITIES HERBAL PRODUCTS OTHER MANUFACTURING/IMPORT ACTIVITIES HOMEOPATHIC PRODUCTS OTHER COATING OF UNIT DOSE SOLIDS, PRODUCTION OF UNIT DOSE AND MULTIPLE OTHER MANUFACTURING/IMPORT ACTIVITIES DOSE POWDERS, PREPARATION OF HERBAL MIXTURES FOR INFUSION FOR ORAL USE & EXTERNAL USE AS A COMPRESS

Date of Publication 01 August 2015 Veterinary Only Page 13 of 13