National Health Service (Pharmaceutical Services) Regulations 2005 Regulation 1

Statutory Document No. 2005/0727 c National Health Service Act 2001

NATIONAL HEALTH SERVICE (PHARMACEUTICAL SERVICES) REGULATIONS 20051

Laid before Tynwald: 15 November 2005 Coming into Operation: 1 January 2006

In exercise of the powers conferred on the Department of Health and Social Security by section 8 of the National Health Service Act 20011 and of all other enabling powers, and after the consultations required by section 42(5) of that Act, the following Regulations are hereby made: -.

1 Citation, commencement and interpretation (1) These Regulations may be cited as the National Health Service (Pharmaceutical Services) Regulations 2005, and shall come into operation on the 1st January 2006. (2) In these Regulations — “the Act” means the National Health Service Act 2001; “appliance” means an appliance which is included in a list for the time being approved by the Department; “appropriate non-proprietary name” means a non-proprietary name other than a non-proprietary name mentioned in Schedule 3 (drugs, medicines and other substances not to be ordered under a general medical services contract) or Schedule 4 (drugs or medicines to be ordered only in certain circumstances), but a non-proprietary name mentioned in Schedule 4 may be an appropriate non-proprietary name if it is a drug, medicine or other substance specified in any entry in column 1 of that Schedule and— (a) if the patient is a person of a description mentioned in column 2 of that entry; (b) that drug, medicine or other substance is prescribed for that patient only for the purpose specified in column 3 of that entry; and (c) the medical practitioner endorses the form with the reference “SLS”;2

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National Health Service (Pharmaceutical Services) Regulations Regulation 1 2005

“associated batch issue” means, in relation to a repeatable prescription, one of the batch issues relating to that prescription and containing the same date as that prescription; “the Association” means the Isle of Man Pharmacy Contractor’s Association; “batch issue” means a form provided by the Department and issued by a prescriber at the same time as a repeatable prescription to enable a pharmacist to receive payment for the provision of repeat dispensing services, and which — (a) is generated by a computer and not signed by a prescriber; (b) relates to a particular repeatable prescription and contains the same date as that prescription; (c) is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs or appliances ordered on the repeatable prescription may be provided; and (d) specifies a number denoting its place in the sequence referred to in sub-paragraph (c); “British Approved Name” or “BAN” means the official generic and non- proprietary name for an active pharmaceutical drug or active ingredient for use in the United Kingdom;3 “British Approved Modified Name” or “BANM” means a modified BAN which represents the active molecules needed to be expanded for various reasons such as formulation purposes, bioavailability or absorption rate;4 “Charges Regulations” means the National Health Service (Charges for Drugs and Appliances) Regulations 20042; “child” means a person who has not attained the age of 16 years; “dentist” means a dental practitioner (within the meaning of the Dental Act 1985)3; “director” means — (a) a director of a body corporate; or (b) a member of the body of persons controlling a body corporate; “doctor” means a medical practitioner who is registered with the General Medical Council;5 “drugs” includes medicines; “Drug Tariff” has the meaning given to it by regulation 14; “employment” means any employment whether paid or unpaid and whether under a contract for services or a contract of service, and “employed” and “employer” shall be construed accordingly;

2 SD 22/04 as amended by SD 728/05, SD 511/10 and SD 118/13 3 1985 c.29

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National Health Service (Pharmaceutical Services) Regulations 2005 Regulation 1

“essential services” has the meaning given in paragraph 3 of Schedule1; “ETP service” means the 2-dimensional barcoded prescription service which forms part of the information technology systems in prescribing and dispensing systems and used by the Department to transfer and hold prescription information relating to patients;6 “EU marketing authorisation” means a marketing authorisation granted or renewed by the European Commission under Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as last amended on 7 January 2019;7 “General Medical Council” means the Council established under the Medical Act 19834 (an Act of Parliament);8 “General Pharmaceutical Council register” means the register maintained under article 19 of the Pharmacy Order 20105;9 “GMS contract” means a general medical services contract6; “GMS contractor” means a party to a GMS contract other than the Department; “health care professional” means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Healthcare Professions Act 20027 (an Act of Parliament); “independent nurse prescriber” means a person — (a) who is registered in the Nursing and Midwifery Register, and (b) in respect of whom an annotation signifying that he is qualified to order drugs and appliances from — (i) the Nurse Prescribers’ Formulary for District Nurses and Health Visitors in Part XVIIB(i) of the Drug Tariff, or (ii) the Nurse Prescribers’ Extended Formulary in Part XVIIB(ii) of the Drug Tariff, is also recorded in that register; “International Nonproprietary Name” or “INN” means an official generic and non-proprietary name given to a pharmaceutical drug or an active ingredient, which is a unique name that is globally recognised and is public property;10 “International Nonproprietary Name Modified” or “INNM” means a name created by the British Pharmacopoeia Commission based on an existing

4 1983 c.54 5 SI 2010/231 6 Made under s.31 of the Act. 7 2000 c.17 c SD No. 2005/0727 Page 3

National Health Service (Pharmaceutical Services) Regulations Regulation 1 2005

INN in line with the World Health Organization’s INN Working Document 05.167/3;11 “licensing or regulatory body” means a body that licenses or regulates any profession of which the person is or has been a member, and includes any body which licenses or regulates any such profession in a country other than the United Kingdom; “medicinal product” means any substance or combination of substances that— (a) are presented as having properties of preventing or treating disease in human beings; or (b) may be used by or administered to human beings with a view to— (i) restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action; or (ii) making a medical diagnosis;12

“Misuse of Drugs Regulations” means the Misuse of Drugs Regulations 20018;13 “NHS services” means services provided as part of the health service continued under section 1(1) of the Act; “non-proprietary name” means a name which is, or which is a permitted variation of— (a) an International Nonproprietary Name (INN); (b) an International Nonproprietary Name Modified(INNM); (c) a British Approved Name (BAN); (d) a British Approved Modified Name (BANM); or (e) an approved name, and for this purpose these names (and their permitted variations) have the same meanings as in a list of names which has been prepared and caused to be published by the British Pharmacopoeia Commission and which has not been superseded9;14 “notice” means a notice in writing (including electronic) and “notify” shall be construed accordingly; “Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 200110 (as that Order has effect in the United Kingdom);15

8 SI 2001/3998 as applied to the Island by the Misuse of Drugs (Miscellaneous Enactments)(Application) Order 2013 (SD 0310/13), as amended by SD 2016/0254. 9 The British Pharmacopoeia 2019 is the leading collection of standards for UK medicinal products and pharmaceutical substances and is available at www.pharmacopoeia.com 10 SI 2002/253

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National Health Service (Pharmaceutical Services) Regulations 2005 Regulation 1

“patient” means a person for whom a pharmacist agreed to provide pharmaceutical services; “patient list” means a list of patients kept by the Department; “pharmaceutical list” shall be construed in accordance with regulation 3; “pharmaceutical services” means pharmaceutical services other than directed services; “pharmacist” means, except where the context otherwise requires — (a) a registered pharmacist; or (b) a person lawfully conducting a retail pharmacy business in accordance with section 35 of the Medicines Act 200311 “pharmacy” means any premises registered under section 40 of the Medicines Act 2003; “preliminary consent” has the meaning given to it in regulation 11; “prescriber” means a doctor, dentist, independent nurse prescriber or a supplementary prescriber; “prescription form” means a form provided by the Department, and issued by a doctor, dentist, supplementary prescriber or independent nurse prescriber to enable a person to obtain pharmaceutical services under the Act; “prescription only medicine” means any of the following— (a) a medicinal product that is covered by a UK marketing authorisation or an authorisation issued under Part 8 of the Human Medicines Regulations 2012 (of Parliament)3 of which it is a term that the product is to be available only on prescription; (b) a medicinal product that— (i) is covered by an EU marketing authorisation; and (ii) is classified in the authorisation as a prescription only medicine; (c) a medicinal product that is a prescription only medicine by virtue of Part 1 of Schedule 1 to the Human Medicines Regulations 2012 (of Parliament); or (d) a medicinal product that is the result of— (i) the assembly; or (ii) the reformulation (including the combining with other substances), of a medicinal product that is a prescription only product referred to in sub-paragraph (a) or (b);16

“the Prescription of Drugs Regulations” [Revoked]17

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National Health Service (Pharmaceutical Services) Regulations Regulation 1 2005

“primary carer” means, in relation to an adult, the adult or organisation primarily caring for him; “professional conduct” includes matters relating both to professional conduct and professional performance; “professional registration number” [Revoked]18

“relevant register” [Revoked]19 “repeat dispensing services” means pharmaceutical services which involve the provision of drugs or appliances by a pharmacist in accordance with a repeatable prescription; “repeatable prescriber” means a person (a) who is a GMS contractor who provides repeatable prescribing services under the terms of its contract; (b) employed or engaged by a GMS contractor who provides repeatable prescribing services under the terms of a contract; “repeatable prescription” means a prescription which (a) is contained in a form provided by the Department and issued by a repeatable prescriber and which is generated by a computer and signed by a repeatable prescriber; or (b) is issued or created to enable a person to obtain pharmaceutical services; and (c) indicates that the drugs or appliances ordered on that prescription may be provided more than once, and specifies the number of occasions on which they may be provided; “restricted availability appliance” means an appliance which is approved for particular categories of persons or particular purposes only; “Scheduled drug” means a drug or other substance specified in Schedule 3 (drugs, medicines and other substances not to be ordered under a general medical services contract) or Schedule 4 (drugs or medicines to be ordered only in certain circumstances);20 “serious shortage protocol” means a written protocol that— (a) is issued by the Department if the Island is, in the opinion of the Department, experiencing or may experience a serious shortage of— (i) a prescription only medicine; or (ii) any other specified drug or appliance; (b) provides for the supply by a pharmacist of a different quantity, strength or pharmaceutical form of product to that which is ordered on a prescription form or repeatable prescription, subject to any conditions which may be specified in the protocol; and (c) specifies the period for which the protocol is to have effect;21

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National Health Service (Pharmaceutical Services) Regulations 2005 Regulation 2

“SSP” means a serious shortage protocol;22 “superintendent” has the same meaning as it has in section 37 of the Medicines Act 2003; “supplementary prescriber” means a person- — (a) whose name is registered in — (i) the Nursing and Midwifery Register, (ii) the Register of Pharmaceutical Chemists maintained in pursuance of section 2(1) (the registers and registration) of the Pharmacy Act 1954, or (iii) the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 200212 relating to-- — (aa) chiropodists and podiatrists, (bb) physiotherapists, (iv) radiographers: diagnostic or therapeutic; and (b) against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs and appliances as a supplementary prescriber; “terms of service” shall be construed in accordance with regulation 2; “UK marketing authorisation” means a marketing authorisation granted by the licensing authority under— (a) Part 5 of the Human Medicines Regulations 2012 (of Parliament); or (b) Chapter 4 of Title III (mutual recognition and decentralised procedure to Directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating to medicinal products for human use.23

2 Terms of service The arrangements for the provision of general pharmaceutical services which it is the duty of the Department under section 8 of the Act to make shall incorporate the terms of service specified in Schedule 1.24

3 Pharmaceutical list (1) The pharmaceutical list shall contain the following details of those pharmacists whose applications to be included in the list have been granted — (a) the addresses of premises from which those services are provided;

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National Health Service (Pharmaceutical Services) Regulations Regulation 4 2005

(b) the days on which and times at which pharmaceutical services are provided at that address (including times at which those services are provided when the person is not obliged to do so); (2) The pharmaceutical list shall be available for public inspection.

4 Application for inclusion in list (1) A pharmacist who wishes to be included in the pharmaceutical list shall send to the Department an application providing the information set out in Schedule 2. (2) The application shall be determined by an officer nominated by the Department for the purpose, who shall inform the applicant of their decision and, where the application is refused, the reasons for refusal in accordance with regulation 5 and of the right to appeal under regulation 10. (3) A pharmacist shall within 14 days of any change or addition affecting the entries which the pharmaceutical list is required to contain in relation to him notify the Department accordingly.

5 Grounds for refusal (1) The grounds on which the Department may refuse an application under regulation 4 are — (a) that, having regard to the .information provided in Schedule 2 and any other information in its possession, it considers that the applicant is unsuitable to be included on the pharmaceutical list; (b) that it is not satisfied with the references given, or that no or insufficient references have been given, by the referees named by the applicant under paragraph 7 of Schedule 2 (Part 2); (c) that admitting the applicant to the list would be prejudicial to the efficiency of the service which he would undertake; (d) that the proposed practice premises are unsatisfactory; and (e) the applicant does not offer to provide all of the essential services.

6 Necessary or desirable test (1) An application, shall be granted by the Department only if it is satisfied that it is necessary or desirable to grant the application in order to secure, in the neighbourhood in which the premises from which the applicant intends to provide the services are located, the adequate provision, by persons included in a pharmaceutical list, of the services, or some of the services, specified in the application ("the necessary or desirable test"). (2) In considering whether the necessary or desirable test is satisfied, the Department shall have regard in particular to —

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(a) whether or not any pharmaceutical services specified in the application provided by persons included in a pharmaceutical list are already provided by persons in the neighbourhood in which the premises named in the application are located; (b) whether the recipients of pharmaceutical services already have a reasonable choice with regard to — (i) the pharmaceutical services provided in the neighbourhood in which the premises named in the application are located, by persons included in a pharmaceutical list; and (ii) the persons included in a pharmaceutical list from whom such recipients may obtain pharmaceutical services in the neighbourhood in which the premises named in the application are located; (c) any other information available to the Department which, in its opinion, is relevant to the consideration of the application.

7 Notification of applications The Department shall, as soon as is practicable, give notice in writing of an application to — (a) the Association; (b) any person who is included in a pharmaceutical list and whose interests might, in the opinion of the Department, be significantly affected if the application were granted; and any person so notified may, within 45 days from the date on which the notification was sent, make representations in writing to the Department.

8 Determination of applications (1) The Department may determine an application in such manner as it thinks fit and may, if it considers that oral representations are unnecessary, determine the application without hearing any oral representations. (2) In considering any application from an applicant who is not already included in the pharmaceutical list the Department shall — (a) check as far as reasonably practicable the information provided by the applicant; and (b) take up and check the references provided under paragraph 7 of Schedule 2 (Part 2); (3) In any case where the Department decides to hear oral representations, it shall give the applicant and any person from whom it has received representations under regulation 7 not less than 14 days notice of the time and place at which the oral representations are to be heard.

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National Health Service (Pharmaceutical Services) Regulations Regulation 9 2005

(4) The applicant and any person mentioned in regulation 7 may be assisted at any such hearing in the presentation of his representations by some other person, but no person shall be entitled to be heard in the capacity of advocate. (5) The procedure by which representations are heard shall be such as the Department may determine. (6) No person — (a) who provides or assists in providing pharmaceutical services under Part 2 of the Act; (b) who holds a GMS contract, or is a legal and beneficial shareholder in, or director or company secretary of a company which holds a GMS contract, or is employed or engaged by a person who holds such a contract; shall take part in any decision under this regulation. (7) The Department may, where it thinks fit, consider two or more applications together in relation to each other: and, where it proposes to do so, it shall give notice in writing to the applicants and any persons to whom copies of the application were sent under regulation 7.

9 Notification of decision The Department shall, as soon as practicable and in any event within the period of four months beginning with the date of receipt of the application give notice in writing of its decision on an application under regulation 4, to — (a) the applicant; (b) any person who is included in a pharmaceutical list and whose interests might, in the opinion of the Department, be significantly affected by the decision; and (c) the Association.

10 Appeal (1) Where an application to be included in the pharmaceutical list has been refused, the applicant may appeal to the Department by giving notice in writing to the Department, stating the grow1ds of appeal, within 21 days after refusal is notified to him, or within such further time as the Department may allow. (2) The Department shall appoint a person (being a member or officer of the Department) to determine the appeal, who, if he considers that it can properly be determined without an oral hearing, shall determine the appeal summarily and notify the applicant of his decision. (3) If the appointed person does not determine the appeal summarily under paragraph (2), he shall, not less than 7 days before the date fixed for the

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hearing, notify the appellant and the nominated officer of the time and place at which the appeal will be heard. (4) The applicant and the nominated officer may attend the hearing and be heard either in person or by an advocate or other representative. The procedure at the hearing shall be such as the appointed person may determine. (5) The appointed person shall as soon as may be thereafter notify the applicant and the nominated person in writing of his decision on the appeal, with the grounds therefor, and if he allows the appeal shall direct the nominated officer to grant the application.

11 Preliminary consent to be included in a pharmaceutical list (1) A person to whom regulation 4(1) applies may apply to the Department for consent (in these Regulations referred to as "preliminary consent"). (2) An application for preliminary consent shall be in writing and shall — (a) specify the premises or the location of the premises from which the applicant intends to provide pharmaceutical services if his application is granted; (b) specify the pharmaceutical services which it is proposed to provide; and (c) provide the information set out in Part 1 of Schedule 2. (3) An application for preliminary consent shall be determined as if it were an application made under regulation 4. (4) A preliminary consent shall have effect for a period of 6 months from its final grant. (5) In this regulation and in regulation 12, an application for preliminary consent shall not be treated as finally granted until the end of the period for bringing an appeal relating to that application under any provision of these Regulations or until the determination of any such appeal, whichever is the later, and "final grant" shall be construed accordingly.

12 Effect of preliminary consent (1) Subject to paragraph (2), where the applicant has been finally granted preliminary consent, the Department shall grant an application made under regulation 4 provided that — (a) the date of the application under regulation 4, being the date on which the application was received by the Department, falls within the period referred to in regulation 11(4); (b) the pharmaceutical services which it is proposed to provide are the same as those specified in the application for preliminary consent; and

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National Health Service (Pharmaceutical Services) Regulations Regulation 13 2005

(c) the premises specified in the application are within the location in respect of which the preliminary consent was granted. (2) Where sub-paragraphs (a) and (b) of paragraph (1) are satisfied, but the premises specified in the application are in different location from that in respect of which preliminary consent was granted, the Department shall treat the application as though it were a new application under regulation 4.

13 Removal from pharmaceutical list (1) Where the Department has determined that a pharmacist has ceased to be a pharmacist, it shall remove his name from the pharmaceutical list. (2) If it appears to the Department that a pharmacist whose name has been included for the preceding 6 months in the pharmaceutical list has not during that period provided general pharmaceutical services for persons on the Island, it shall refer the matter to an officer nominated by it, who shall — (a) give to the pharmacist 28 days notice of the proposal to remove his name from the list; (b) afford the pharmacist an opportunity to make representations to him in writing or, if he so wishes, orally; and (c) consult the Association. (3) Nothing in these regulations prejudices the right of a pharmacist to have his name included again in the pharmaceutical list.

14 Drug Tariff (1) For the purpose of enabling arrangements to be made for the provision of general pharmaceutical services, the Parts of the Drug Tariff published by the Welsh Ministers under regulation 41 of the Welsh Regulations that are specified in paragraphs (2) and (3) apply in the Island in respect of those services provided by the Department. (2) The following Parts of the Drug Tariff referred to in paragraph (1) as they are published from time to time are specified for the purposes of that paragraph— (a) IIIA Professional fees (Pharmacy Contractors); (b) IV Consumables and containers; (c) V Deduction scale (Pharmacy Contractors); (d) VID Advanced services (Pharmacy and Appliance Contractors) - Care Home Service, Medicine Review Service, Minor Ailment Scheme, Needle and Syringe Exchange Scheme, On Demand Availability of Specialist Drugs Service, Out of Hours Service,

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Schools Service, Screening Service, Stop Smoking Service and Supervised Administration Service; (e) VIE Enhanced services (Pharmacy Contractors); (f) VIIIA Basic prices of drugs; (g) VIIIB Arrangements for payment for specials and imported unlicensed medicines; (h) IX Appliances (approved list of appliances – notes); (i) IXB Incontinence appliances; (j) IXC Stoma appliances; (k) XIIB Essential Small Pharmacies Scheme (ESPS); (l) Borderline substances; (m) XVI Notes on charges; (n) XVIIA Dental prescribing; (o) XVIIC National out-of-hours formulary; (p) XVIIIA Drugs ordered in accordance with a general medical services contract; (q) XVIIIB Drugs that may only be ordered in certain circumstances; and (r) XVIIIC Criteria notified under the transparency Directive. (3) The following parts of the Drug Tariff referred to in paragraph (1) as published in March 2018 are specified for the purpose of that paragraph— (a) VIA Payment for essential services (pharmacy contractors); (b) VIIB Collaborative Working Scheme; and (c) VIIC Quality and Safety Scheme. (4) A reference in these Regulations to the “Drug Tariff” is to be construed in accordance with this regulation. (5) In this regulation “the Welsh Regulations” means the National Health Service (Pharmaceutical Services) (Wales) Regulations 201313.25

15 Payment for services (1) The Department shall make payments to contractors in accordance with provisions of the Drug Tariff. (2) Where the Department considers that it has made a payment to a contractor owing to an error or in circumstances where it was not due, it shall, draw the overpayment to the attention of the contractor and — (a) where he admits overpayment; or

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(b) where he does not admit the overpayment but, the matter having been referred for investigation, the Department decides there has been an overpayment, the amount overpaid shall be recoverable either by deduction from the contractor’s remuneration or in some other manner. (3) (3) Recovery of an overpayment under this regulation shall be without prejudice to the investigation of an alleged breach of the terms of service.

15A Schedules 3 and 4 Schedules 3 and 4 have effect.26

16 Revocations The National Health Service (General Pharmaceutical Services) Regulations 200414 are revoked.

MADE 29 SEPTEMBER 2005

14 SD 20/04

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National Health Service (Pharmaceutical Services) Regulations 2005 SCHEDULE 1

SCHEDULE 1

TERMS OF SERVICE OF PHARMACISTS

[Regulation 2]27

PART 1

Incorporation of provisions

1. Any provisions of the following affecting the rights and obligations of pharmacists form the terms of service for pharmacists— (a) these Regulations; and (b) the Drug Tariff.28

Division of responsibilities between individuals and corporate bodies

2. (1) To the extent that this Schedule imposes a requirement on a pharmacist in respect of an activity which could only, or would normally, be undertaken by a natural person — (a) if the pharmacist is a registered pharmacist — (i) that registered pharmacist must comply with that requirement, or (ii) if he employs or engages a registered pharmacist in connection with the provision of pharmaceutical services, that registered pharmacist must either comply with that requirement or secure compliance with that requirement by a registered pharmacist whom he employs or engages; and (b) if the pharmacist is not a natural person, that pharmacist must secure compliance with that requirement by the registered pharmacists whom he employs or engages. and references in this Schedule to a pharmacist shall be construed accordingly. (2) Where this Schedule imposes a requirement on the director or superintendent of a body corporate that is a pharmacist, breach of that requirement shall be deemed to be a breach by the pharmacist of his terms of service.

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PART 2

ESSENTIAL SERVICES

Essential services

3. For the purposes of these Regulations, "essential services" means- — (a) the services described in this Part; and (b) the activities described in this Part to be carried out in connection with those services.

Dispensing services

4. A pharmacist shall, to the extent that paragraphs 5 to 9 require and in the manner described in those paragraphs, provide proper and sufficient drugs and appliances to persons presenting a prescription form for that drug or appliance by a prescriber in pursuance of his functions in the health service.29

Dispensing of drugs and appliances

5. (1) Subject to the following provisions of this Part, where any person presents a prescription form which contains- — (i) an order for drugs, not being Scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber; (ii) an order for a drug specified in Schedule 4 (drugs or medicines to be ordered only in certain circumstances), signed by a prescriber and including the reference "SLS"; or30 (iii) an order for a restricted availability appliance, signed by a prescriber and including the reference "SLS", a pharmacist shall, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as he supplies in the normal course of his business. (2) Subject to the following provisions of this Part, where — (a) any person presents a repeatable prescription which contains- — (i) an order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 197615, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations, signed by a repeatable prescriber;

15 1976 c.21

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(ii) an order for a drug specified in Schedule 4 (drugs or medicines to be ordered only in certain circumstances), not being a controlled drug within the meaning of the Misuse of Drugs Act 1976, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations, signed by a repeatable prescriber and including the reference "SLS";31 (iii) an order for appliances, not being restricted availability appliances, signed by a repeatable prescriber; or (iv) an order for a restricted availability appliance, signed by a repeatable prescriber, and including the reference "SLS", and also presents an associated batch issue; or (b) the pharmacist receives a repeatable prescription which contains an order of a kind specified in paragraph (a)(i) to (iv) and — (i) any person requests the provision of drugs or appliances in accordance with that repeatable prescription; or (ii) the pharmacist has previously arranged with the patient that he will dispense that repeatable prescription on receipt, a pharmacist shall, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as he supplies in the normal course of his business. (3) For the purposes of this paragraph, a repeatable prescription for drugs or appliances shall be taken to be presented even if the person who wishes to obtain the drugs or appliances does not present that prescription, where — (a) the pharmacist has that prescription in his possession; and (b) that person presents, or the pharmacist has in his possession, an associated batch issue.

Supply in accordance with a SSP32

5A. (1) This sub-paragraph applies if— (a) any person requests a drug or appliance from a pharmacist (P) in accordance with a prescription form or repeatable prescription; and (b) a SSP has effect in respect of— (i) the requested drug or appliance; or (ii) a drug or appliance of a specified description, and the requested drug or appliance is of that description. (2) If sub-paragraph (1) applies, P must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.

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(3) If sub-paragraph (1) applies, P may provide a different quantity, strength or pharmaceutical form of product to that ordered on the prescription form or repeatable prescription, if— (a) P is able to do so with reasonable promptness; (b) to do so is in accordance with the SSP; and (c) the supply of a different quantity, strength or pharmaceutical form to that ordered by the prescriber is by or under the direct supervision of a registered pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different quantity, strength or pharmaceutical form of product to that ordered by the prescriber is reasonable and appropriate. (4) If P, in accordance with sub-paragraph (3), provides a different quantity, strength or pharmaceutical form of product to that ordered by the prescriber— (a) the registered pharmacist mentioned in sub-paragraph (3)(c) must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff then in the manner provided for in the Drug Tariff), and the prescription or associated batch issue as endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription); and (b) if— (i) the patient to or for whom the product is provided is on a patient list; and (ii) the Department, after consulting with the body and professions mentioned in section 42(5) of the National Health Service Act 2001 in respect of pharmaceutical remuneration of pharmacists, has issued and publicised a recommendation to the effect that for clinical reasons, in the case of supplies of that type, providers of primary health services should be notified of a supply to a patient on its patient list that is in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription, P must notify the provider of primary health services on whose patient list the patient is of the supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription. (5) If— (a) sub-paragraph (1) applies;

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(b) a registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different quantity, strength or pharmaceutical form of product to that ordered by the prescriber is unreasonable or inappropriate; and (c) P is able to supply the quantity, strength and pharmaceutical form of product ordered by the prescriber within a reasonable timescale but not with reasonable promptness, the requirement to act with reasonable promptness in paragraph 5.(2) is to be read as a requirement to act within a reasonable timescale.33

Urgent supply without a prescription

6. Where, in a case of urgency, a prescriber personally known to a pharmacist requests him to provide a drug, the pharmacist may provide that drug before receiving a prescription form or repeatable prescription, provided that — (a) that drug is not a Scheduled drug; (b) that drug is not a controlled drug within the meaning of the Misuse of Drugs Act 1976, other than a drug which is for the time being specified in Schedules 4 or 5 to the Misuse of Drugs Regulations; and (c) the prescriber undertakes to give the pharmacist a prescription form or repeatable prescription in respect of the drug within 72 hours.

Preliminary matters before providing ordered drugs or appliances

7. (1) If a person specified in paragraph (2) asks the pharmacist to do so — (a) the pharmacist shall give an estimate of the time when the drugs or appliances will be ready; and (b) if they are not ready by then, the pharmacist shall give a revised estimate of the time when they will be ready (and so on). (2) The persons referred to in paragraph (1) are a person — (a) presenting a prescription form or repeatable prescription; or (b) requesting the provision of drugs or appliances in accordance with a repeatable prescription. (3) Before providing any drugs or appliances in accordance with a prescription form or a repeatable prescription the pharmacist shall ask any person who makes a declaration that the person named on the prescription form or the repeatable prescription does not have to pay the charges specified in regulation 4 of the Charges Regulations to produce satisfactory evidence of such entitlement. unless the declaration is in respect of entitlement to exemption by virtue of sub-paragraph (a), (c), (f), (g) or (h) of regulation 4(1) of the Charges Regulations, and at the time of the declaration the pharmacist already bas such evidence available to him.

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(4) If, in the case of a prescription form or repeatable prescription, no satisfactory evidence, as required by sub-paragraph (3), is produced to the pharmacist, the pharmacist shall endorse the form on which the declaration is made to that effect.

Providing ordered drugs or appliances

8. (1) Where a pharmacist is presented with, or receives from the ETP service, a prescription form or a repeatable prescription, the pharmacist shall only provide the drugs or appliances so ordered- — (a) if the prescription form or repeatable prescription is duly signed and completed as described in paragraph 5; and (b) in accordance with the order on the prescription form or repeatable prescription, subject to any regulations in force under the Weights and Measures Act 198916 and the following provisions of this Part. (2) Drugs or appliances so ordered shall be provided either by or under the direct supervision of a pharmacist. (3) If the order is for, or a product to be provided in accordance with a SSP is, an appliance of a type requiring measuring and fitting by the pharmacist (for example a truss), the pharmacist shall make all necessary arrangements for — (a) measuring the person named on the prescription form or repeatable prescription for the appliance; and (b) fitting the appliance.34 (4) If the order is for or a product to be provided in accordance with a SSP is, a drug or appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner’s Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the drug or appliance provided shall comply with the standard or formula specified therein.35 (5) If the order — (a) is an order for a drug; but (b) is not an order for a controlled drug within the meaning of the Misuse of Drugs Regulations other than a drug which is for the time being specified in Schedules 4 or 5 to those Regulations, and does not prescribe its quantity, strength or dosage, a pharmacist may provide the drug in such strength and dosage as in the exercise of his professional skill, knowledge and care he considers to be· appropriate and, subject to sub-paragraph (6) in such quantity as he considers to be appropriate for a course of treatment for a period not exceeding five days. (6) Where an order to which sub-paragraph (5) applies is for• ( (a) an oral contraceptive substance;

16 1989 c.1

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(b) a drug, which is available for supply as part of pharmaceutical services only together with one or more other drugs; or (c) an antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require its provision in an unopened package, which is not available for provision as part of pharmaceutical services except in such packages that the minimum size available contains a quantity appropriate to a course of treatment for a period of more than 5 days, the pharmacist may provide the minimum size available package. (7) Where any drug, not being one to which the Misuse of Drugs Regulations apply, ordered by a prescriber on a prescription form or repeatable prescription. is available for provision by a pharmacist in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is — (a) sterile; (b) effervescent or hygroscopic; (c) a liquid preparation for addition to bath water; (d) a coal tar preparation; (e) a viscous preparation; or (f) packed at the time of its manufacture in a calendar pack or special container; the pharmacist shall, subject to sub-paragraph (8), provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered (8) A pharmacist shall not provide, pursuant to sub-paragraph (7), a drug in a calendar pack where, in his opinion. it was the intention of the prescriber who ordered the drug that it should be provided only in the exact quantity ordered. (9) In this paragraph — (a) "calendar pack" means a blister or strip pack showing the days of the week or month against each of the several units in the pack; and (b) "special container" means any container with an integral means of application or from which it is not practicable to dispense an exact quantity. (10) Except as provided in sub-paragraph (11), a pharmacist shall not provide a Scheduled drug in response to an order by name, formula or other description on a prescription form or repeatable prescription. (11) Where a drug has an appropriate non-proprietary name and it is ordered on a prescription form or repeatable prescription either by that name or by its formula, a pharmacist may provide a drug which has the same specification notwithstanding that it is a Scheduled drug, provided that where a Scheduled drug is a pack which consists of a drug in more than one strength, such provision does not involve the supply of part only of the pack (12) Where a drug which is ordered as specified in sub-paragraph (11) combines more than one drug, that sub-paragraph shall apply only if the combination

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National Health Service (Pharmaceutical Services) Regulations SCHEDULE 1 2005 has an appropriate non-proprietary name, whether the individual drugs which it combines do so or not. (13) A pharmacist shall provide any drug which he is required to provide under this paragraph in a suitable container. (14) If P provides a drug or appliance under paragraph 5A, P must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.36

Refusal to provide drugs or appliances ordered

9. (1) A pharmacist may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where- — (a) the pharmacist reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because he reasonably believes it has been stolen or forged); (b) it appears to the pharmacist that there is an error on the prescription form or on the repeatable prescription or, in the case of a repeatable prescription, its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the drugs or appliances would be contrary to the pharmacist’s clinical judgement; (c) the pharmacist or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with a repeatable prescription, or by any person accompanying that person; or (d) the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with a repeatable prescription, or any other person accompanying that person, commits or threatens to commit a criminal offence. (2) A pharmacist shall refuse to provide a drug ordered on a prescription form or repeatable prescription where the order is for a prescription only medicine which the prescriber was not entitled to prescribe. (2A) P must refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription if— (a) a SSP has effect in respect of— (i) the requested drug or appliance; or (ii) a drug or appliance of a specified description, and the requested drug or appliance is of that description; and (b) alternative provision has already taken place in accordance with the SSP.37

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(2B) P may refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription if— (a) a SSP has effect in respect of— (i) the requested drug or appliance; or (ii) a drug or appliance of a specified description, and the requested drug or appliance is of that description; (b) a registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different quantity, strength or pharmaceutical form to that ordered by the prescriber is unreasonable or inappropriate; and (c) P is unable to provide the drug or appliance within a reasonable timescale, but if P does refuse to do so, P must provide the patient or the person requesting the drug or appliance on behalf of a patient with appropriate advice, as necessary, about reverting to the prescriber for the prescriber to review the patient’s treatment.38 (3) A pharmacist shall refuse to provide drugs or appliances ordered on a repeatable prescription where — (a) he has no record of that prescription; (b) he does not have any associated batch issue and it is not presented to him; (c) it is not signed by a repeatable prescriber; (d) to do so would not be in accordance with any intervals specified in the prescription; (e) it would be the first time a drug or appliance had been provided p t to the prescription and the prescription was signed more than six months previously; (f) if the repeatable prescription was signed more than one year previously; or (g) the expiry date on the repeatable prescription has passed. (4) If presented with a repeatable prescription, a pharmacist shall only provide the drugs or appliances order if he is satisfied — (a) that the patient to whom the prescription relates — (i) is taking or using, and is likely to continue to take or use, the drug or appliance appropriately, and (ii) is not suffering from any of the treatment which indicates the need or desirability of reviewing the patient’s treatment; (b) that the medication regimen of the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient’s treatment;

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(c) there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient’s treatment.

Further activities to be carried out in connection with the provision of dispensing services

10. In connection with the services provided under paragraph 4, a pharmacist shall — (a) ensure that appropriate advice is given to patients about any drugs or appliances provided to them — (i) to enable them to utilise the drugs or appliances appropriately, and (ii) to meet the patient’s reasonable needs for general information about the drugs or appliances; (b) provide appropriate advice to patients to whom they provide drugs or appliances on- — (i) the safe keeping of the drugs or appliances, and (ii) returning unwanted drugs or appliances to the pharmacy for safe destruction; (c) provide appropriate advice to patients to whom they provide drugs or appliances in accordance with a repeatable prescription in particular on the importance of only requesting those items which they actually need; (d) provide a patient with a written note of any drug or appliance which is owed, and inform the patient when the drug or appliance will become available; (e) keep and maintain records — (i) of drugs and appliances provided, where it is necessary or desirable to do so in order to facilitate the continued care of the patient; (ii) in appropriate cases, of advice given and any interventions or referrals made (in particular of clinically significant interventions in cases involving repeatable prescriptions), and (iii) of notes provided under sub-paragraph (d); (f) undertake appropriate training in respect of repeat prescribing, having regard to any recommendations in respect of such training set out in the Drug Tariff; (g) if he takes possession of a repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;

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(h) maintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied); (i) ensure that where a person is refused drugs or appliances pursuant to paragraphs 9(l)(b), (3) or (4), the patient is referred back to the prescriber for further advice; and (j) where a patient is provided with drugs or appliances under a repeatable prescription, notify the person responsible for the prescription of any clinically significant issues arising in connection with the prescription and keep a record of that notification, and in particular of any refusal to provide drugs or appliances pursuant to paragraph 9(4).

Disposal service in respect of unwanted drugs

11. A pharmacist shall, to the extent paragraph 12 requires and in the manner described in that paragraph, accept and dispose of unwanted drugs presented to him for disposal.

Basic procedure in respect of unwanted drugs

12. (1) Subject to sub-paragraph (2), where a person presents to a pharmacist or any of his staff any drugs provided for a patient in, and which have been kept in — (a) a private household; or (b) a residential care home, the pharmacist shall accept the drugs and dispose of them in accordance with sub- paragraph (3). (2) A pharmacist shall not be required to accept any drugs for disposal unless the Department with which he is listed has made arrangements with the pharmacist for the collection and disposal of drugs of that description. (3) On receipt of the drugs, the pharmacist shall — (a) separate solid drugs or ampoules, liquids and aerosols from each other; (b) store the drugs in containers provided by the Department, or by a waste disposal contractor retained by the Department for the purpose of storing drugs of that description; and (c) comply with any other statutory requirements in respect of storing or the disposal of drugs of that description (meeting those requirements are therefore an essential service for the purposes of these Regulations), and shall co-operate with any suitable arrangements that the Department has in place for regular collection of the drugs from his premises by or on behalf of the Department

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Further activities to be carried out in connection with the disposal of unwanted drugs

13. In connection with the services provided under paragraph 11, a pharmacist shall — (a) ensure that he and any staff he has, are aware of the risks associated with the handling of waste drugs and the correct procedures to be used to minimise those risks; and (b) ensure that he and any staff he has have readily available and close to any place where waste drugs are stored appropriate protective equipment, including gloves, overalls and materials to deal with spillages.

Promotion of healthy lifestyles

14. A pharmacist shall, to the extent paragraphs 15 and 16 require, and in the manner set out in those paragraphs, promote public health messages to members of the public.

Prescription linked intervention

15. Where a person using a pharmacy- — (a) presents a prescription form or repeatable prescription to a pharmacist; and it appears to the pharmacist that the person — (i) has diabetes, (ii) is at risk of coronary heart disease or high blood pressure, or (iii) smokes or is overweight, the pharmacist shall, as appropriate, provide advice to that person with the aim of increasing that person’s knowledge and understanding of the health issues which are relevant to that person’s personal circumstances. (2) Advice given under sub-paragraph (1) may be backed up, as appropriate — (a) by the provision of written material (for example leaflets); and (b) by referring the person to other sources of information or advice. (3) A pharmacist shall, in appropriate cases, keep and maintain a record of advice given pursuant to this paragraph, and that record shall be in a form that facilitates- — (a) auditing of the provision of pharmaceutical services by the pharmacist; and (b) follow-up care for the person who has been given the advice.

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Public health campaigns

16. A pharmacist shall, at the request of the Department ensure that he and any staff he has participate, in the manner reasonably requested by the Department in up to six campaigns in each calendar year to promote public health messages to users of his pharmacy.

Signposting

17. A pharmacist shall, to the extent paragraph 18 requires and in the manner set out in that paragraph, provide information to users of its pharmacy about other health and social care providers and support organisations.

Service outline in respect of signposting

18 (1) Where it appears to a pharmacist or his staff, having regard to the need to minimise inappropriate use of health and social care services and of support services, that a person using his pharmacy — (a) requires advice, treatment or support that the pharmacist cannot provide; but (b) another provider, of which the pharmacist is aware, of health or social care services or of support services is likely to be able to provide that advice, treatment or support, the pharmacist shall provide contact details of that provider to that person and shall, in appropriate cases, refer that person to that provider. (2) Where appropriate, a referral under paragraph (1) may be made by means of a written referral note. (3) The pharmacist shall, in appropriate cases, keep and maintain a record of any information given or referral made under paragraph (1) and that record shall be in a form that facilitates- — (a) auditing of the provision of pharmaceutical services by the pharmacist; and (b) follow-up care for the person who has been given the information or in respect of whom the referral has been made.

Support for self-care

19. A pharmacist shall, to the extent paragraph 20 requires and in the manner set out in that paragraph, provide advice and support to people caring for themselves or their families.

Service outline in respect of support for self-care

20 (1) Where it appears to a pharmacist or his staff, having regard to the need to minimise the inappropriate use of health and social care services, that a person using his

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National Health Service (Pharmaceutical Services) Regulations SCHEDULE 1 2005 pharmacy would benefit from advice from the pharmacist to help him manage a medical condition (including, in the case of a carer, to help the carer in assisting in the management of another person’s medical condition), the pharmacist shall provide advice to the person using the pharmacy as regards managing the medical condition, including as appropriate advice- — (a) on treatment options, including advice on the selection and use of appropriate drugs which are not prescription only medicines; and (b) on changes to the patient’s lifestyle. (2) The pharmacist shall, in appropriate cases, keep and maintain a record of any advice given under sub-paragraph (1) and that record shall be in a form that facilitates- — (a) auditing of the provision of pharmaceutical services by the pharmacist; and (b) follow-up care for the person to whom or in respect of whom the advice has been given.

PART 3

HOURS OF OPENING

Pharmacy opening hours: general

21 (1) A pharmacist shall ensure that pharmaceutical services are provided at each of the premises from which he has undertaken to provide pharmaceutical services — (a) for not less than 40 hours each week; (b) if the Department has directed that — (i) he may provide pharmaceutical services at the premises for fewer than 40 hours per week, provided that he provides those services at set times and on set days, or (ii) he must provide pharmaceutical services at the premises for more than 40 hours per week, and at set times and on set days, at the times and on the days so set. (2) Subject to sub-paragraph (3), at each of the premises from which a pharmacist has undertaken to provide pharmaceutical services, he shall exhibit — (a) a notice specifying the days on which and times at which the premises are open for the provision of drugs and appliances; and (b) at times when the premises are not open, a notice based on information provided by the Department, legible from outside the premises, specifying the addresses of other pharmacists included

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in the pharmaceutical list and the days on which and times at which drugs and appliances may be obtained from those addresses. (3) A pharmacist shall, on request, submit a return to the Department setting out — (a) provided at each of the premises from which he has undertaken to provide pharmaceutical services (including times at which he is providing pharmaceutical services when he is not obliged to do so); and (b) the pharmaceutical services which he ordinarily provides at each of those premises, but all pharmacists, if they are on a pharmaceutical list on 1st November 2005, shall supply such a return to the Department by 1st January 2006 and shall state in that return if the days and times submitted represent a change to the days on which and times at which they provided pharmaceutical services at those premises prior to 1st November 2005. (4) Where a pharmacist, who has submitted a return under sub-paragraph (3) in respect of any premises, changes — (a) the days on which or times at which pharmaceutical services are to be provided at those premises; or (b) the pharmaceutical services which he is ordinarily to provide at those premises, be shall supply the Department with a return informing it of the change. (5) Where a pharmacist who is on a pharmaceutical list on 1st April 2005 has submitted a return under sub-paragraph (3) in respect of any premises, he shall not change — (a) the days on which or the times at which pharmaceutical services are to be provided at those premises; or (b) the pharmaceutical services which he is ordinarily to provide those premises, for a period of at least three months after the return that was submitted under that paragraph was received by the Department. (6) Subject to sub-paragraph (7), where a pharmacist is prevented by illness or other reasonable cause from complying with his obligations under sub-paragraph (1), he shall, where practicable, make arrangements with one or more pharmacists whose premises are situated in the neighbourhood for the provision of pharmaceutical services or local pharmaceutical services during that time. (7) Where there is a temporary suspension in the provision of pharmaceutical services by a pharmacist for a reason beyond the control of the pharmacist, the pharmacist shall not be in breach of sub-paragraphs (1) and (2), provided that — (a) he notifies the Department of that suspension as soon as practical; and (b) he uses all reasonable endeavours to resume provision of pharmaceutical services as soon as is practicable.

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(8) Planned refurbishment of a pharmacy is neither a "reasonable cause" for the purposes of sub-paragraph (6) nor a "reason beyond the control of the pharmacist" for the purposes of sub• paragraph (7). (9) For the purposes of calculating the number of hours that a pharmacy is open during a week that includes Christmas Day, Good Friday or a bank holiday, it shall be deemed that the pharmacy was open on that day at the times at which it would ordinarily have been open on that day of the week.

Matters to be considered when issuing directions in respect of pharmacy opening hours

22 (1) Where the Department issues a direction setting any days or times under this Part, it shall in doing so seek to ensure that the hours at which premises are open for the provision of pharmaceutical services are such as to ensure that pharmaceutical services are provided on such days and at such times as are necessary to meet the needs of people in the neighbourhood, or other likely users of the pharmacy, for pharmaceutical services. (2) In considering the matters mentioned in sub-paragraph (1), the Department shall• ( (a) neighbourhood at the days and times in question as if they were pharmaceutical services being so provided; and (b) have regard to any pharmaceutical services that are being provided in that neighbourhood in circumstances where the pharmacist is not obliged to provide those services. (3) The Department may only direct that a pharmacist may provide pharmaceutical services at premises for less than 40 hours in any week if it is satisfied that the provision of pharmaceutical services in the neighbourhood is likely to be adequate to meet the need for such services at times when the pharmacist is not providing pharmaceutical services. (4) The Department may only direct that a pharmacist must provide pharmaceutical services at premises for more than 40 hours in any week where it is satisfied that he will receive reasonable remuneration in respect of the additional hours for which he is required to provide pharmaceutical services (and any additional remuneration payable under the Drug Tariff in respect of those hours is "reasonable remuneration" for these purposes).

Determination of pharmacy opening hours instigated by the Department

23 (1) Where it appears to the Department that the days on which or times at which a pharmacy is or will be open for the provision of pharmaceutical services will not, or no longer meet, the needs of — (a) people in the neighbourhood; or (b) other likely users of his pharmacy, for pharmaceutical services, it shall carry out an assessment as to whether to issue a direction requiring the pharmacist whose pharmacy it is to provide pharmaceutical

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National Health Service (Pharmaceutical Services) Regulations 2005 SCHEDULE 1 services at the pharmacy at set times and on set days (which may include Christmas Day, Good Friday and bank holidays). (2) Before concluding the assessment under sub-paragraph (1) the Department shall — (a) give notice to the pharmacist of any proposed changes to the days on which or times at which the pharmacy is to be open; and (b) allow him 30 days within which to make written representations to the Department about the proposed changes. (3) After considering any representations made in accordance with sub- paragraph (2)(b), the Department shall — (a) issue a direction (which will replace any existing direction) setting the days on which and the times at which the pharmacist must provide pharmaceutical services at the pharmacy; (b) confirm any existing direction setting the days on which and the times at which the pharmacist must provide pharmaceutical services at the pharmacy, whether issued under this Part ; (c) either — (i) revoke (without replacing it) any existing direction setting the days on which or times at which the pharmacist must provide pharmaceutical services at the pharmacy, whether issued under this Part, or (ii) in a case where there is no existing direction, issue no direction, in which case, by virtue of paragraph 21(1)(a), the pharmacy will need to be open for not less than 40 hours each week (4) The Department shall notify the pharmacist in writing of any direction issued or any other action taken under sub-paragraph (3), and where it sets new days on which or times at which the pharmacist is to provide pharmaceutical services at the pharmacy, it shall include with the notification a statement in writing of — (a) the reasons for the change; and (b) the pharmacist’s right of appeal under sub-paragraph (5). (5) A pharmacist may, within 30 days of receiving notification under sub- paragraph (4) appeal in writing to the Department against any direction issued or any other action taken under sub• paragraph (3) which sets new days on which or times at which the pharmacist is to provide pharmaceutical services. (6) The Department shall determine the appeal in accordance with regulation 10. (7) If the days on which or times at which a pharmacist is to provide pharmaceutical services at a pharmacy have been changed in accordance with this paragraph, the pharmacist shall introduce the changes- — (a) if he has not appealed under sub-paragraph (5), not later than 8 weeks after the date on which he receives his notification under sub-paragraph (4); or c SD No. 2005/0727 Page 31

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(b) if he has appealed under sub-paragraph (5), not later than 8 weeks after the date on which he receives his notification under regulation 10.

Determination of pharmacy opening hours instigated by the pharmacist

24 (1) A pharmacist may apply to the Department for it to change the days on which or times at which he is obliged to provide pharmaceutical services at his pharmacy in a way that — (a) reduces the total number of hours for which the pharmacist is obliged to provide pharmaceutical services each week; or (b) keeps that total number of hours the same. (2) Where a pharmacist makes an application under sub-paragraph (1), as part of that application he shall provide the Department with such information as may reasonably request in respect of any changes to the needs of the people in the neighbourhood, or other likely users of the pharmacy, for pharmaceutical services that are material to the application. (3) The Department shall determine an application under sub-paragraph (1) within 60 days of receiving it (including any information required of the applicant in accordance with paragraph (2)). (4) In determining the application, the Department shall — (a) issue a direction (which will replace any existing direction) — (i) setting the days on which and the times at which the pharmacist must provide pharmaceutical services at the pharmacy, and (ii) which has the effect of either granting the application under this paragraph or granting it only in part; (b) confirm any existing direction setting the days on which and the times at which the pharmacist must provide pharmaceutical services at the pharmacy, whether issued under this Part; (c) either — (i) revoke (without replacing it) any existing direction setting the days on which or times at which the pharmacist must provide pharmaceutical services at the pharmacy, whether issued under this Part, where this has the effect of granting the application under this paragraph or granting it only in part, or (ii) in a case where there is no existing direction, issue no direction, in which case, by virtue of paragraph 21(1)(a), the pharmacy will need to be open for not less than 40 hours each week.. (5) Where the Department is considering taking action under sub-paragraph (4)(a) or (c)(i), it shall consult the Association before determining the application.

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(6) The Department shall notify the pharmacist in writing of any direction issued or any other action taken under sub-paragraph (4), and where this has the effect of refusing an application under this paragraph or granting it in part, it shall send the pharmacist a statement in writing setting out — (a) the reasons for the refusal or, as the case may be, for granting the application only in part; and (b) the pharmacist’s right of appeal under sub-paragraph (7). (7) A pharmacist may, within 30 days of receiving a notification pursuant to sub- paragraph (6), appeal in writing to the Department against any action under sub- paragraph (4) which bas the effect of refusing an application under this paragraph. (8) The Department shall determine the appeal in accordance with regulation 10. (9) If the days on which or times at which a pharmacist is to provide pharmaceutical services at a pharmacy have been changed in accordance with this paragraph, the pharmacist shall introduce the changes — (a) if he has not appealed under sub-paragraph (7), not earlier than 30 days after the date on which he receives his notification under sub- paragraph (6); or (b) if he has appealed under sub-paragraph (7), not earlier than 30 days after the date on which he receives his notification under regulation 10.

PART 4

CLINICAL GOVERNANCE, FITNESS TO PRACTISE AND COMPLAINTS

Clinical governance

25 (1) A pharmacist shall, in connection with all the pharmaceutical services provided by him, participate, in the manner reasonably required by the Department, in an acceptable system of clinical governance. (2) For these purposes a system of clinical governance is "acceptable" if it is considered acceptable by the Department and comprises the following components — (a) a patient and public involvement programme, which includes — (i) a requirement that the pharmacist should produce in an approved manner, and make available in an appropriate manner, a practice leaflet in respect of his pharmacy; (ii) a requirement that the pharmacist publicises the NHS services that are available at or from his pharmacy; (iii) a requirement that the pharmacist should undertake an approved patient satisfaction survey annually, in an approved manner;

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(iv) monitoring arrangements for drugs or appliances owed to patients but which are out of stock; (v) an approved complaints system (which meets the requirements of this Part); and (vi) a requirement that the pharmacist co-operates appropriately with any reasonable inspection or review that the Department or any relevant statutory authority wishes to undertake; (b) a clinical audit programme (normally of five days), which includes at least one pharmacy-based audit and one multi-disciplinary audit agreed by the Department in each financial year; (c) a risk management programme, which includes — (i) arrangements for ensuring that all stock are handled in an appropriate way; (ii) arrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately; (iii) an approved incident reporting system, together with arrangements for analysing and responding to critical incidents; (iv) appropriate standard operating procedures, including standard operating procedures in respect of repeatable prescriptions and providing advice and support to people caring for themselves or their families; (v) appropriate waste disposal arrangements (in addition to those required under Part 2) for clinical and confidential waste; (vi) a clinical governance lead person in respect of each pharmacy; appropriate child protection procedures; and (vii) monitoring arrangements for compliance with the Health and Safety Etc. Act 197717; (d) a clinical effectiveness programme, which includes arrangements for monitoring the effectiveness of the advice given by a pharmacist in respect of repeatable prescriptions or to people caring for themselves or their families; (e) a staffing and staff management programme, which includes-- — (i) arrangement for appropriate induction training for staff and locums; (ii) appropriate training for all staff in respect of any role they are asked to perform;

17 1977 c.1

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(iii) arrangements for the checking of qualifications and references of all staff engaged in the provision of NHS services; (iv) arrangements for identifying and supporting the development needs of all staff engaged in the provision of services as part of the health service (apart from pharmacists, whose development needs are covered under paragraph (f)); (v) arrangements for addressing poor performance (in conjunction with the Department as appropriate); (f) an education, training, continuing professional and personal development of pharmacists programme, which includes appropriate arrangements in respect of continuing professional development and any necessary accreditation in respect of the provision of directed services; and (g) a use of information programme, which includes appropriate arrangements (having regard to issues both of rights of access to information and of confidentiality) to support both health care delivery and clinical governance, and for the purposes of this sub-paragraph, "approved" means approved by the Department.

Professional Standards

26. A pharmacist shall provide pharmaceutical services and exercise any professional judgement in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession.

Inducements etc.

27 (1) A pharmacist or his staff shall not give, promise or offer to any person any gift or reward {whether by way of a share of or dividend on the profits of the business or by way of discount or rebate or otherwise) as an inducement to or in consideration of his presenting an order for drugs or appliances on a prescription form or repeatable prescription. (2) Promising, offering or providing a compliance aid or a home delivery service is not a gift or reward for the purposes of sub-paragraph (1).

Duty to provide information about fitness to practice matters: pharmacists on pharmaceutical lists on 1st April 2005

28 (1) In the case of a pharmacist who is on a pharmaceutical list on 1st April 2005, the pharmacist and where the pharmacist is a body corporate every director and superintendent of the pharmacist shall, by 3rd October 2005, supply in writing information to the Department as to whether he- —

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(a) has any criminal convictions; (b) has been bound over following a criminal conviction; (c) has accepted a police caution; (d) has been convicted elsewhere of an offence, or what would constitute a criminal offence if committed in the Isle of Man; (e) is currently the subject of any proceedings which might lead to such a conviction, which have not yet been notified to the Department;. (f) has been subject to any investigation into his professional conduct by any licensing, regulatory or other body, where the outcome was adverse; (g) is currently subject to any investigation into his professional conduct by any licensing, regulatory or other body; or (h) is, or bas been where the outcome was adverse, subject to an investigation into his professional conduct in respect of any current or previous employment, and if so, he shall give details of any investigation or proceedings which were or are to be brought, including the nature of that investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome. (2) If a person to whom sub-paragraph (1) applies is, or was at the time of the originating events, a director or superintendent of a body corporate, he shall in addition and at the same time supply in writing information to the Department as to whether the body corporate-- — (a) has any criminal convictions; (b) has been convicted elsewhere of an offence, or what would constitute a criminal offence if committed in the Isle of Man; (c) is currently the subject of any proceedings which might lead to such a conviction, which have not yet been notified to the Department; (d) has been subject to any investigation into its provision of professional services by any licensing, regulatory or other body, where the outcome was adverse; (e) is currently subject to any investigation into its provision of professional services by any licensing, regulatory or other body; and if so, he shall give the name and registered office of the body corporate, and details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome. (3) A person to whom sub-paragraph (1) or (2) applies shall consent to a request being made by the Department to any employer or former employer or licensing

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National Health Service (Pharmaceutical Services) Regulations 2005 SCHEDULE 1 or regulatory body in the United Kingdom or elsewhere, for information relating to a current investigation, or an investigation where the outcome was adverse.

Duty to provide information about fitness to practise matters as they arise

29 (1) A pharmacist and where the pharmacist is a body corporate, every director and superintendent of the pharmacist shall, within 7 days of its occurrence, inform the Department in writing if he — (a) is convicted of any criminal offence; (b) is bound over following a criminal conviction; (c) accepts a police caution; (d) is convicted elsewhere of an offence, or what would constitute a criminal offence if committed in the Isle of Man; (e) is charged in the Isle of Man with a criminal offence, or is charged elsewhere with an offence which, if committed in the Isle of Man, would constitute a criminal offence; (f) is notified by any licensing, regulatory or other body of the outcome of any investigation into his professional conduct, and there is a finding against him; (g) becomes the subject of any investigation into his professional conduct by any licensing, regulatory or other body; (h) becomes subject to an investigation into his professional conduct in respect of any current or previous employment, or is notified of the outcome of any such investigation and any finding against him; and if so, he shall give details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome. (2) If a person to whom sub-paragraph (1) applies is, or was at the time of the originating events, a director or superintendent of a body corporate, he shall in addition inform the Department within 7 days if any such body corporate — (a) is convicted of any criminal offence; (b) is convicted elsewhere of an offence, or what would constitute a criminal offence if committed in the Isle of Man; (c) is charged in the Isle of Man with a criminal offence, or is charged elsewhere with an offence which, if committed in the Isle of Man, would constitute a criminal offence; (d) is notified by any licensing, regulatory or other body of the outcome of any investigation into its provision of professional services, and there is a finding against the body corporate; (e) becomes the subject of any investigation into its provision of professional services by any licensing, regulatory or other body;

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and if so, he shall give the name and registered office of the body corporate and details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome. (3) A person to whom sub-paragraph (1) or (2) applies shall consent to a request being made by the Department to any employer or former employer or licensing or regulatory body in the United Kingdom or elsewhere, for information relating to a current investigation, or an investigation where the outcome was adverse.

Complaints

30. A pharmacist shall have in place arrangements for the handling and consideration of complaints about any matter connected with his provision of pharmaceutical services as if the National Health Service (Complaints) Regulations 200418 applied to him.

PART 5

OTHER TERMS OF SERVICE

Information to be supplied

31 (1) A pharmacist shall give notice to the Department within 28 days (or if this is impracticable, as soon as practicable thereafter) of any occurrence requiring a change in the information recorded about him in the pharmaceutical list and of any change of his private address. (2) A pharmacist shall give the Department, if it so requests, the name of any pharmacist employed by him for the provision of drugs for persons from whom he has accepted a prescription form or a repeatable prescription. (3) A pharmacist that is a body corporate shall (if he is on a pharmaceutical list on 1st April 2005, by 3rd October 2005) supply to the Department in writing the name and address of each of his directors and superintendent, and any changes to the names and addresses of each of its directors and superintendent.

Withdrawal from pharmaceutical lists

32. Where a pharmacist intends to withdraw from the pharmaceutical list, he shall notify the Department of this at least three months in advance of that date unless it is impracticable for him to do so in which case he shall notify the Department as soon as it is practicable for him to do so.

18 SD 216/04

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Charges for drugs and refunds

33 (1) Subject to regulations made under section 32 of the Act, all drugs, containers and appliances provided under these terms of service shall be provided free of charge. (2) Where a pharmacist supplies a container in response to an order for drugs signed by a prescriber, or supplies an oxygen container or oxygen equipment, other than equipment specified in the Drug Tariff as not returnable to the pharmacist, the container and equipment shall remain the property of the pharmacist.

Inspections and access to information

34 (1) A pharmacist shall allow persons authorised in writing by the Department to enter and inspect his pharmacy at any reasonable time, for the purposes of — (a) ascertaining whether or not the pharmacist is complying with the requirements of this Schedule; (b) auditing, monitoring and analysing — (i) the provision made by the pharmacist, in the course of providing pharmaceutical services, for patient care and treatment, and (ii) the management by the pharmacist of the pharmaceutical services he provides, where the conditions in sub-paragraph (2) are satisfied. (2) The conditions are that — (a) reasonable notice of the intended entry has been given; (b) the person authorised in writing carries written evidence of his authorisation, which he produces on request; and (c) he does not enter any part of the premises used solely as residential accommodation without the consent of the resident. (3) A pharmacist shall, at the request of the Department or of the person authorised in writing mentioned in sub-paragraph (1), allow it or him access to any information which it or he reasonably requires- — (a) for the purposes mentioned in sub-paragraph (1); or (b) in the case of the Department, in connection with its functions that relate to pharmaceutical services.

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National Health Service (Pharmaceutical Services) Regulations SCHEDULE 2 2005

SCHEDULE 2

[Regulation 4]

PART 1

INFORMATION TO BE INCLUDED IN AN APPLICATION FOR INCLUSION IN A PHARMACEUTICAL LIST

2 APPLICATION

The type of consent applied for (preliminary or full)

The type of application

A declaration that the pharmaceutical services will be provided at the premises during the hours specified in the application

3 DETAILS OF APPLICANT

Name and address of applicant

Name and address of premises if different

Proposed opening hours

Proposed contractual hours

Name and registration number in the General Pharmaceutical Council register of the applicant’s superintendent (Where the applicant is a corporate body)39

Whether the applicant is currently in possession of the premises

The applicant’s registration number in the General Pharmaceutical Council register40

(Where the applicant is a corporate body) The applicant’s company registration number

4 PHARMACEUTICAL SERVICES TO BE PROVIDED

Confirmation that all essential services will be provided

5 SUPPORTING INFORMATION

Reasons why the applicant considers the granting of the application is necessary or desirable in order to secure the adequate provision of pharmaceutical services in that neighbourhood

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6 RELOCATIONS

Reasons for the relocation

Where the application is in relation to a minor relocation, information as to why the relocation is minor and the distance of the new premises from the old premises by the nearest practicable route where this is less than 500 metres

Whether the provision of services will be continuous or interrupted, together with the reasons for any interruption

7 CHANGE OF OWNERSHIP

Name of previous owner

Whether the provision of services will be continuous or interrupted, together with the reasons for any interruption

8 REMOVAL FROM EXISTING PREMISES OR REMOVAL OF SERVICES

Details of the premises from which the services are being withdrawn

The services to be withdrawn

A declaration that the applicant is withdrawing from existing premises or removing services

PART 2

INFORMATION AND UNDERTAKINGS TO BE GIVEN BY AN APPLICANT IN CONNECTION WITH AN APPLICATION FOR INCLUSION IN THE PHARMACEUTICAL LIST

1. An applicant (other than an applicant which is a body corporate) shall provide the following information — (a) his full name; (b) his sex; (c) his date of birth; (d) his private address and telephone number; (e) a declaration that he is a registered pharmacist; (f) his registration number in the General Pharmaceutical Council register and date of first registration in the register.41

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National Health Service (Pharmaceutical Services) Regulations SCHEDULE 2 2005

2. An applicant which is a body corporate shall provide the following information — (a) its full name; (b) its company registration number; (c) its registered office and telephone number relating to that office; (d) a declaration that it is a person who is or who will be lawfully conducting a retail pharmacy business in accordance with section 35 of the Medicines Act 2003.

3. An applicant shall provide an undertaking to notify the Department within 7 days of any material changes to the information provided in the application until the application is finally determined.

4. An applicant shall supply in writing information as to whether he, or where the applicant is a body corporate, any of its directors or its superintendent — (a) has any criminal convictions; (b) has been bound over following a criminal conviction; (c) has accepted a police caution in the Isle of Man or elsewhere; (d) has been convicted elsewhere of an offence, or what would constitute a criminal offence if committed in the Isle of Man; (e) is currently the subject of any proceedings which might lead to such a conviction, which have not yet been notified to the Department; (f) has been subject to any investigation into his professional conduct by any licensing, regulatory or other body, where the outcome was adverse; (g) is currently subject to any investigation into his professional conduct by any licensing, regulatory or other body; (h) is, or has been where the outcome was adverse, the subject of any investigation into his professional conduct in respect of any current or previous employment.

5. If the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) is, has in the preceding six months been, or was at the time of the originating events, a director or superintendent of a body corporate, he shall in addition supply information in writing to the Department as to whether the body corporate — (a) has any criminal convictions; (b) has been convicted elsewhere of an offence, or what would constitute a criminal offence if committed in the Isle of Man; (c) is currently the subject of any proceedings which might lead to such a conviction, which have not yet been notified to the Department;

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(d) has been subject to any investigation into its provision of professional services by any licensing, regulatory or other body, where the outcome was adverse; (e) is currently subject to any investigation into its provision of professional services by any licensing, regulatory or other body.

6. Where the applicant (or where the applicant is a body corporate, any director or superintendent of the applicant) is a pharmacist, the applicant shall supply details of his pharmaceutical qualifications (including where obtained) and chronological details of his professional experience (including starting and finishing dates of each appointment), with an explanation of any gaps between appointments and of why he was dismissed from any post.

7. Where the applicant (or where the applicant is a body corporate, any director or superintendent of the applicant) is a pharmacist, the applicant shall supply names and addresses of two referees who are willing to provide references in respect of two recent posts (which may include any current post) as a pharmacist which lasted at least three months without a significant break, or where this is not possible, a full explanation and alternative referees.

8. Where the applicant is a body corporate, the name and address of each director and superintendent of the body corporate shall be supplied.

9. If, in the case of any application, the Department finds that the information, references or documentation supplied by the applicant are not sufficient for it to decide his application, it shall seek from him such further information, references or documentation as it may reasonably require in order to make a decision and he shall supply the material so sought to the Department.

10. The applicant shall give a written undertaking to notify the Department within 7 days of any material changes to the information provided in his application until such time as — (a) his name is entered on the pharmaceutical list; (b) in respect of which the application was made has expired and he has not done so; (c) he withdraws the application; (d) in the case of an applicant who has been granted preliminary consent the period during which the preliminary consent has effect has expired; or (e) the period for appealing against a Department’s decision to refuse an application has expired and no appeal has been lodged, or an application has been refused on appeal.

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National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

SCHEDULE 342

[Regulation 15A]

DRUGS, MEDICINES AND OTHER SUBSTANCES NOT TO BE ORDERED UNDER A GENERAL MEDICAL SERVICES CONTRACT

10.10 Cleaning and Disinfecting Solution 10.10 Rinsing and Neutralising Solution 10 Day Slimmer Tablets 10 Hour Capsules 4711 Cologne Abidec Capsules Acarosan Foam Acarosan Moist Powder Acclaim Flea Control Aerosol Plus Acnaveen Bar Acne Aid Bar Actal Suspension Actal Tablets Actifed Compound Linctus Actifed Cough Relief Actifed Expectorant Actifed Linctus with Codeine Actifed Syrup Actifed Tablets Actomite Actonorm Gel Actonorm Powder Actonorm Tablets Actron Tablets Adpack Europe Gamolenic Acid (GLA) Capsules Adreno-Lyph Plus Tablets Adult Cough Balsam (Cupal) Adult Meltus Cough and Catarrh Linctus Adult Tonic Mixture (Thornton and Ross) Advanced Nutrition Bee Pollen Granules Advanced Nutrition Bee Propolis Tablets Advanced Nutrition Chromium Compound Liquid Advanced Nutrition Ener-B NSL Gel Advanced Nutrition Herbal Aloe Juice Advanced Nutrition L-Arginine Capsules Advanced Nutrition Linseed Oil Advanced Nutrition Silica-Organic Capsules Advanced Nutrition Sulphur Capsules Advanced Nutrition Vitamin E Capsules Aerocide 2 Spray 400 ml Afrazine Nasal Drops Afrazine Nasal Spray Afrazine Paediatric Nasal Drops Agarol Emulsion

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National Health Service (Pharmaceutical Services) Regulations 2005 SCHEDULE 3

Agiolax Granules Airbal Breathe Easy Vapour Inhaler AL Tablets Alagbin Tablets Allbee with C Capsules Allbee with C Elixir Alcin Tablets Alcon Salette Aerosol Saline Solution Aletres Cordial (Potters) Alexitol Sodium Suspension 360 mg/5 ml Alexitol Sodium Tablets Algipan Rub Algipan Tablets Alka-Donna P Mixture Alka-Donna P Tablets Alka-Donna Suspension Alka-Donna Tablets Alka-Seltzer Tablets Alka Mints Alket Powders Aller-eze Plus Tablets Aller-eze Tablets All Clear Shampoo All Fours Cough Mixture (Harwood) All Fours Mixture (Glynwed Wholesale Chemists) All Fours Mixture (Roberts Laboratories) Allinson’s Wholemeal Flour Almasilate Tablets 500 mg Almazine Tablets 1 mg Almazine Tablets 2.5 mg Almay Aftersun Soother Almay Face Powder Almay Sun Protection Cream SPF 12 Almay Ultra Protection Lotion SPF 12 Aloin Tablets 40 mg Alophen Pills Alpine Tea Alprazolam Tablets 0.25 mg Alprazolam Tablets 0.5 mg Alprazolam Tablets 1 mg Altacaps Altacite Plus Tablets Altacite Suspension Altacite Tablets Altelave Liquid Aludrox Gel Aludrox Liquid Aludrox M H Suspension Aludrox S A Suspension Aludrox Tablets Aluhyde Tablets c SD No. 2005/0727 Page 45

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Aluminium Hydroxide & Silicone Suspension Aluminium Phosphate Gel Aluminium Phosphate Tablets 400 mg Alupent Expectorant Mixture Alupent Expectorant Tablets Aluphos Gel Aluphos Tablets Alupram Tablets 2 mg Alupram Tablets 5 mg Alupram Tablets 10 mg Aluzyme Tablets Alzed Tablets Ambre Solaire Cream Factor 8 Ambre Solaire Cream Factor 10 Ambre Solaire High Protection Cream SPF10 Ambre Solaire High Protection Milk SPF 12 American Nutrition Strezz B-Vite Tablets Ami-10 Rinsing and Storage Solution Amiclear Contact Lens Cleanser Tablets Amidose Saline Solution 30 ml Amin-Aid Amisyn Tablets Ammonium Chloride and Morphine Mixture BP Amplex Mouthwash Amplex Mint Capsules Amplex Original Capsules Anadin Analgesic Capsules Maximum Strength Anadin Analgesic Tablets Anadin Extra Analgesic Tablets Anadin Extra Soluble Tablets Anadin Ibuprofen Tablets Anadin Paracetamol Tablets Anadin Tablets Soluble Anaflex Cream Andrews Answer Andrews Antacid Tablets Andrews Liver Salts Effervescent Powder Andrews Liver Salts (Diabetic Formula) Effervescent Powder Andursil Liquid Andursil Tablets Anestan Bronchial Tablets Anethaine Cream Aneurone Mixture Angiers Junior Aspirin Tablets Angiers Junior Paracetamol Tablets Anorvit Tablets Antasil Liquid Antasil Tablets Anthisan Cream Antistin-Privine Nasal Drops Antistin-Privine Nasal Spray

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National Health Service (Pharmaceutical Services) Regulations 2005 SCHEDULE 3

Antitussive Linctus (Cox) Antoin Tablets Antussin Liquid (Sterling Winthrop) Anxon Capsules 15 mg Anxon Capsules 30 mg Anxon Capsules 45 mg Aperient Tablets (Brome and Schimmer) Aperient Tablets (Kerbina) Apodorm Tablets 2.5 mg Apodorm Tablets 5 mg APP Stomach Powder APP Stomach Tablets Appleford’s Gluten-Free Rice Cakes Arnica Lotion Arocin Capsules Arret Capsules Ascorbef Tablets Ascorbic Acid and Hesperidin Capsules (Regent Laboratories) Asilone Antacid Liquid Asilone Antacid Tablets Asilone Orange Tablets Askit Capsules Askit Powders Askit Tablets Aspergum Chewing Gum Tablets 227 mg Aspirin Chewing-Gum Tablets 227 mg Aspirin Tablets, Effervescent Soluble 300 mg Aspirin Tablets, Effervescent Soluble 500 mg Aspirin Tablets, Slow (Micro-Encapsulated) 648 mg Aspro Clear Extra Tablets Aspro Clear Tablets Aspro Extra Strength Tablets 500 mg Aspro Junior Tablets Aspro Microfined Tablets Aspro Paraclear Tablets Aspro Paraclear Junior Tablets Asthma Tablets (Cathay) Astral Moisturising Cream Astroplast Analgesic Capsules Atensine Tablets 2 mg Atensine Tablets 5 mg Atensine Tablets 10 mg Ativan Tablets 1 mg Ativan Tablets 2.5 mg Atrixo Audax Ear Drops Autan Insect Repellent Aveeno Baby Aveeno Bar Aveeno Bar Oilated Aveeno Emulave Bar c SD No. 2005/0727 Page 47

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Aveenobar Ayrtons Analgesic Balm Ayrtons Macleans Formula Tablets B Complex Capsules (Rodale) B Complex Super Capsules (Rodale) B Extra Tablets (British Chemotherapeutic Products) Babezone Syrup Baby Chest Rub Ointment (Cupal) Babylix Syrup Babysafe Tablets Badedas Bath Gelee Balm of Gilead (Robinsons) Balm of Gilead Cough Mixture (Wicker Herbal Stores) Balm of Gilead Liquid (Culpeper) Balm of Gilead Mixture (Potters) Balneum Bath Treatment 150ml pack Balneum Plus Bath Treatment 150ml pack Banfi Hungarian Hair Tonic Banimax Tablets Barker’s Liquid of Life Solution Barker’s Liquid of Life Tablets Barkoff Cough Syrup Barnes-Hind Cleaning and Soaking Solution Barnes-Hind Intensive Cleaner Barnes-Hind No 4 Cleaner Barnes-Hind Wetting and Soaking Solution Bausch and Lomb Cleaning Tablets Bausch & Lomb Concentrated Cleaner (for Hard Lenses) BC500 Vitamin Sachets effervescent Becosym Forte Tablets Becosym Syrup Becosym Tablets Becotab Tablets Bee Health Propolis Capsules Beecham Analgesic Cream Beechams Catarrh Capsules Beechams Day Nurse Capsules Beechams Day Nurse Syrup Beechams Night Nurse Capsules Beechams Night Nurse Cold Remedy Beechams Pills Beechams Powders Beechams Powders Capsule Form Beechams Powders Mentholated Beechams Powders Tablet Form Beehive Balsam Bekovit Tablets Belladonna and Ephedrine Mixture, Paediatric, BPC Bellocarb Tablets Bemax Natural Wheatgerm Benadon Tablets 20 mg

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Benadon Tablets 50 mg Benafed Linctus Benerva Compound Tablets Benerva Injection 25 mg/ ml Benerva Injection 100 mg/ ml Benerva Tablets 3 mg Benerva Tablets 10 mg Benerva Tablets 25 mg Benerva Tablets 50 mg Benerva Tablets 100 mg Benerva Tablets 300 mg Bengers Food Bengue’s Balsam Benylin Chesty Coughs Original Benylin Children’s Cough Linctus Benylin Children’s Coughs Benylin Cough & Congestion Benylin Day & Night Cold Treatment Benylin Day & Night Tablets Benylin Dry Coughs Original Benylin Expectorant Benylin Fortified Linctus Benylin Mentholated Cough & Decongestant Linctus Benylin Non-Drowsy Cough Linctus Benylin Paediatric Benylin with Codeine Benzedrex Inhaler Benzoin Inhalation BP Bepro Cough Syrup Beres Drops Plus Bergasol After Sun Soother Bergasol Ultra Protection Tanning Lotion Best Royal Jelly Capsules Beta Carotene Capsules (Nutri Imports & Exports) Biactol Anti-Bacterial Face Wash Bile Beans Formula 1 Pill Bio-Antioxidant Tablets Biocare Acidophilus Powder Biocare AD206 (Adreno-Zyme) Capsules Biocare Allicin Compound Capsules Biocare Amino-Plex Capsules Biocare Artemisia Compound Capsules Biocare ATP Factor Capsules Biocare Beta-Carotene Capsules Biocare Betaine HCL/Pepsin Capsules 200/100 mg Biocare BGF Bifidophilus Growth Factor Powder Biocare Bio Acidophilus Milk Free Capsules Biocare Bio-A Emulsifying Liquid Biocare Bio-Cysteine Capsules Biocare Biogard Capsules Biocare Bio-Magnesium Capsules 100 mg c SD No. 2005/0727 Page 49

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Biocare Bio-Manganese Capsules Biocare Bio-Plex Powder Biocare Butyric Acid Compound Capsules Biocare Calcidophilus Capsules Biocare Calcium EAP2 Capsules Biocare Candistatin Capsules Biocare Catalase Compound Liquid Biocare Cervagyn Vaginal Cream Biocare Cellguard Forte Capsules Biocare CG233 Capsules Biocare Children’s Multi Vitamin/Mineral Capsules Biocare Cholesteraze Capsules Biocare Chromium Polynicotinate Liquid Biocare Colleginase Capsules Biocare Colon Care Capsules Biocare Cystoplex Powder Biocare Dermasorb Skin Cream Biocare Digestaid Capsules Biocare DMSA Capsules Biocare Efaplex Linseed/GLA Blend Capsules Biocare Enteroplex Powder Biocare Eradicin Forte Capsules Biocare Femforte Capsules Biocare Garlicin Capsules Biocare GLA Complex Tablets Biocare GLA/Co Q10 Catalase Capsules Biocare Glutenzyme Capsules Biocare HCL Pepsin Capsules Biocare Hep 194 (Hepaguard) Capsules Biocare Histazyme Capsules Biocare IMU Power Pack Biocare Int B2 Bifidophilus Bacterium Powder Biocare Iron EAP2 Capsules Biocare Kalmar Capsules Biocare Lactase Enzyme Liquid Biocare Ligazyme Capsules Biocare Linseed Oil Emulsifying Capsules Biocare Lipazyme Capsules Biocare Lipo-Plex Capsules Biocare Lipo-Plex Co-Q10 EPA/DHA Capsules Biocare Magnesium Calcium 2:1 Capsules Biocare Magnesium EAP2 Capsules Biocare Mega GLA Complex Capsules 163 mg Biocare Molybdenum Liquid Biocare Multi-Mineral Complex Capsules Biocare Multivitamin Mineral Capsules Biocare Mycopryl 250 Junior Strength Capsules Biocare Mycopryl 400 Capsules Biocare Mycopryl 680 Capsules Biocare N-Acetyl Glucosamine Capsules Biocare NT 188 (Neurotone) Capsules

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National Health Service (Pharmaceutical Services) Regulations 2005 SCHEDULE 3

Biocare Organic Selenium Capsules 100mcg Biocare Oxy-B15 Complex Capsules Biocare Oxyplex Tablets Biocare Oxy Pro Liquid Biocare Pancrogest Capsules Biocare Paracidin (Citricidal) Oral Drops Biocare Permatrol Capsules Biocare Pit-Enzyme Capsules Biocare Polyzyme Capsules Biocare Polyzyme Forte & Acidophilus Capsules Biocare Polyzyme Forte Capsules Biocare Potassium Ascorbate Capsules Biocare Prolactazyme Capsules Biocare Prolactazyme Tablets Biocare Reduced Glutathione Capsules Biocare Replete Sachets Biocare Sea Plasma Capsules 500 mg Biocare Selenium Complex Tablets 50mcg Biocare Selenium Liquid Biocare Shiitake Mushroom Extract Capsules Biocare Spectrumzyme Capsules Biocare TH207 (Thyro-Zyme) Capsules Biocare Thioproline Capsules Biocare Uritol Capsules Biocare Vegi-Dophilus Capsules Biocare Vitamin B6 Capsules Biocare Vitamin B Compound Capsules Biocare Vitamin B12 Timed Release Capsules Biocare Vitamin C Capsules Biocare Vitamin C Magnesium Ascorbate Powder Biocare Vitamin E Emulsifying Capsules Biocare Vyta Mins Capsules Biocare Zinc Tablets Bio-Carotene Softgel Capsules Bioflav Complex Tablets Bioflav Complex + C Tablets Bioflavonoid C Capsules Bio-Glandin 25 Capsules Bio Harmony Sachets Bio-Health Buffered C500 Capsules Bio-Health Extra Calcium Capsules Bio-Health Zinc Gluconate Capsules Bio-Light Slimming Food Supplement Bio-Quinone Q10 Softgel Capsules Bio-Quinone Q10 Super Softgel Capsules Bioscal Hair Formula Bio Science Basic Health AM Capsules Bio Science Basic Health PM Capsules Bio Science Bio-C Powder Bio Science Cal-Mag Alkaline Capsules Bio Science Chelated Cal-Mag Compound Capsules c SD No. 2005/0727 Page 51

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Bio Science Chelated Zinc Capsules Bio Science Full Spectrum Aminos Powder Bio Science Lipid Enzyme Capsules Bio Science Lo-pH Complete Spectrum Digestive Enzyme Capsules Bio Science Lo-pH Digestive Enzyme Capsules Bio Science MSM Organic Sulphur Capsules Bio Science Non-Acidic Sustained Release Vitamin C Tablets Bio Science Organic Iron Capsules Bio Science Pro Enzyme Capsules Bio Science Pyroxidal 5 Phosphate Capsules Bio Science Selenium Plus Capsules Bio Science Timed Release Vitamin C Tablets Bio Science Vitamin B1 Capsules Bio Science Vitamin B3 Nicotinamide Capsules Bio Science Vitamin B5 Calcium Pantothenate Capsules Bio Science Vitamin B6 Capsules Bio Science Vitamin E Capsules Bio-Selenium + Zinc Tablets Bio-Strath Drops Bio-Strath Elixir Biovital Tablets Biovital Vitamin Tonic Birley’s Antacid Powder Bis-Mag Lozenges Bis-Peps Tablets Bisma-Calna Cream Bisma-Rex Powder Bisma-Rex Tablets Bismag Antacid Powder Bismag Tablets Bismuth Compound Lozenges BPC Bismuth Dyspepsia Lozenges Bismuth Pepsin and Pancreatin Tablets Bismuth, Soda and Pepsin Mixture Bisodol Antacid Powder Bisodol Extra Tablets Bisodol Tablets Bisolvomycin Capsules Bisolvon Elixir Bisolvon Tablets Blackcurrant Cough Elixir (Thornton and Ross) Blackcurrant Seed Oil Capsules Blackcurrant Syrup Compound (Beben) Blackmore’s Acidophilus & Pectin Tablets Blackmore’s Bio C Tablets Blackmore’s Celloid CS36 Calcium Sulphate Tablets Blackmore’s Celloid IP82 Iron pH Tablets Blackmore’s Celloid SS69 Sodium Sulphate Tablets Blackmore’s Citrus C & Acerola Tablets Blackmore’s Duocelloid PP/MP Tablets Blackmore’s Duocelloid PS/MP Tablets

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Blackmore’s Duocelloid S/CF Tablets Blackmore’s Duocelloid SP/S Tablets Blackmore’s Echinacea ACE + Zinc Tablets Blackmore’s Hypericum Tablets Blackmore’s Sodical Plus Tablets Blandax Suspension Blavig Tablets Blood Tonic Mixture (Thompsons) Boldolaxine Tablets Bonemeal Calfos, Vit A Ester, Vit D Tablets Bonomint Chewing Gum Bonomint Tablets Booth’s Cough and Catarrh Elixir Boots Aromatherapy Massage Oil Boots Baby Oil Boots Cold Relief Powder for Solution Boots Compound Laxative Syrup of Figs Boots Cough Relief for Adults Boots Glucosamine Sulphate Capsules Boots Glycerin and Blackcurrant Soothing Cough Relief Boots Hard Lens Soaking Solution Boots Hard Lens Wetting Solution Boots Health Salts Boots Indigestion Plus Mixture Boots Indigestion Powder Boots Lip Salve Boots Menthol & Wintergreen Embrocation Boots Nasal Spray Boots No 7 Vitamin E Skin Cream Boots Orange Drink Boots Soft Lens Cleaning Solution Boots Soft Lens Comfort Solution Boots Soft Lens Soaking Solution Boots Soya Milk Boots Vapour Rub Ointment Boston Lens Cleaning Solution Boston Lens Wetting and Soaking Solution Box’s Balm of Gilead Cough Mixture Bravit Capsules Bravit Tablets Breoprin Tablets 648 mg Brewers Yeast Tablets (3M Health Care) Brewers Yeast-Super B Tablets (Rodale) Brewers Yeast Tablets (Phillips Yeast Products) Bricanyl Compound Tablets Bricanyl Expectorant Brogans Cough Mixture Brogans Cough Syrup Bromazepam Tablets 1.5 mg Bromazepam Tablets 3 mg Bromazepam Tablets 6 mg c SD No. 2005/0727 Page 53

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Bromhexine Hydrochloride Elixir 4 mg/5 ml Bromhexine Hydrochloride Tablets 8 mg Bronalin Decongestant Bronalin Dry Cough Linctus Bronalin Expectorant Bronalin Paediatric Cough Syrup Bronchial & Cough Mixture (Worthington Walter) Bronchial Balsam (Cox) Bronchial Catarrh Syrup (Rusco) Bronchial Cough Mixture (Evans Medical) Bronchial Emulsion (Three Flasks) (Thornton & Ross) Bronchial Emulsion AS Extra Strong (Ayrton Saunders) Bronchial Mixture (Rusco) Bronchial Mixture Extra Strong (Cox) Bronchial Mixture Sure Shield Brand Bronchial Tablets (Leoren) Bronchialis Mist Liquid (Industrial Pharmaceutical Services) Bronchialis Mist Nig Double Strength (Phillip Harris Medical) Bronchisan Childrens Cough Syrup Bronchisan Cough Syrup Broncholia Mixture Bronchotone Solution Bronkure Cough & Bronchitis Mixture (Jacksons) Brontus Syrup Brontus Syrup for Children Brontussin Cough Suppressant Mixture Brooklax Tablets Brotizolam Tablets 0.125 mg Brotizolam Tablets 0.25 mg Bufferin Tablets Build-Up (Nestle Health Care) Buttercup Baby Cough Linctus Buttercup Syrup Buttercup Syrup Honey and Lemon Cabdrivers Adult Linctus Cabdrivers Diabetic Linctus Cabdrivers Junior Linctus Cabdrivers Nasal Decongestant Tablets Cadbury’s Coffee Compliment Cafadol Tablets Caffeine & Dextrose Tablets Cal-A-Cool Aftersun Moisturising Cream Caladryl Cream Caladryl Lotion Calamage Calcia Calcium Supplement Tablets Calcimax Syrup Calcinate Tablets Calcium Syrup (Berk Pharmaceuticals) Calendolon Ointment California Syrup of Figs

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Calpol Extra Tablets Calpol Infant Suspension Calpol Six Plus Suspension Calpol Tablets Calsalettes Sugar Coated Tablets Calsalettes Uncoated Tablets Camfortix Linctus P1 Camphor Spirit Candacurb Capsules Candacurb-E Capsules Canderel Intense Sweetner Spoonful Candermyl Liposome Cream Cantaflour Cantamac Tablets Cantamega 1000 Tablets Cantamega 2000 Divided Dose Tablets 3 Size Cantamega 2000 Naturtab Tablets Cantassium Amino M.S. Tablets Cantassium Discs Cantassium Fructose Cantassium Multivitamin Tablets Capramin Tablets Caprystatin Capsules Carbellon Tablets Carbo-Cort Cream Carisoma Compound Tablets Carnation Coffeemate Carnation Slender Meal Replacement (All Flavours) Carrzone Powder Carters Little Pills Carylderm Shampoo Cascara Evacuant Liquid Mixture Cascara Tablets BP Castellan No 10 Cough Mixture Catarrh & Bronchial Syrup (Thornton & Ross) Catarrh Cough Syrup (Boots) Catarrh-Ex Tablets Catarrh Mixture (Herbal Lab Laboratories) Catarrh Syrup for Children (Boots) Catarrh Tablets (Cathay) Ce-Cobalin Syrup Ceeyees Tablets Celaton Rejuvenation Tablets Celaton CH3 Strong & Calm Tablets Celaton CH3 Triplus Tablets Celaton CH3 + Ease and Vitality Tablets Celaton Whole Wheat Germ Capsules Celavit 1 Powder Celavit 2 Powder Celavit 3 Powder Celevac Granules c SD No. 2005/0727 Page 55

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Centrax Tablets 10 mg Cephos Powders Cephos Tablets Cetaphil Lotion Charabs Tablets Charvita Tablets Cheroline Cough Linctus Cherry Bark Cough Syrup Children’s (Loveridge) Cherry Bark Linctus Adults (Loveridge) Cherry Cough Balsam (Herbal Laboratories) Cherry Cough Linctus (Savory & Moore) Cherry Cough Mixture (Rusco) Cherry Flavoured Extract of Malt (Distillers) Chest & Cough Tablets (Brome & Schimmer) Chest & Cough Tablets (Kerbina) Chest & Throat Tablets No 8,000 (English Grains) Chest Pills (Brome & Schimmer) Chest Tablets (Kerbina) Chesty Cough Syrup (Scott & Bowne) Chickweed Ointment Chilblain Tablets (Boots) Child’s Cherry Flavoured Linctus (Cupal) Children’s Blackcurrant Cough Syrup (Rusco) Children’s Cherry Cough Syrup (Thornton and Ross) Children’s Cough Linctus (Ransoms) Children’s Cough Mixture (Beecham) Children’s Cough Mixture (Loveridge) Children’s Cough Syrup (Ayrton Saunders) Children’s Cough Syrup (Cox) Children’s Cough Syrup (Evans Medical) Children’s Cough Syrup (Thornbers) Children’s Medicine Liquid (Hall’s) Children’s Phensic Tablets Children’s Wild Cherry Cough Linctus (Evans Medical) Chilvax Tablets Chlorasol Sachets Chocolate Laxative Tablets (Isola) Chocovite Tablets Christy’s Rich Lanolin Christy’s Skin Emulsion Cidal Cidex Longlife Cidex Sterilising Solution Cinnamon Essence Medicinal Mixture (Langdale) Cinnamon Tablets Medicinal (Langdale) Cinota Drops Citrosan Powder Clara’s Kitchen Gluten-Free Porridge Claradin Effervescent Tablets Clarityn Allergy Clarkes Blood Mixture

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Clean and Soak Cleansing Herb Dried (Potters) Cleansing Herbs (Brome & Schimmer) Cleansing Herbs Powder (Dorwest) Clen-Zym Tablets Clerz Lubricating and Rewetting Eye Drops Clerz Lubricating, Cleaning and Comfort Sachets Clinique Clarifying Lotion Clinique Continuous Coverage Clinique Crystal Clear Cleaning Oil Clinique Dramatically Different Moisturising Lotion Clinique Facial Mild Soap Clinisan Skin Cleansing Foam Clinisan Skin Cleansing Foam Aerosol 500 ml Clorazepate Dipotassium Capsules 7.5mg Clorazepate Dipotassium Capsules 15mg Clorazepate Dipotassium Tablets 15mg Co-op Aspirin Tablets BP 300mg Co-op Bronchial Mixture Co-op Halibut Liver Oil Capsules BP Co-op Paracetamol Tablets BP 500mg Co-op Soluble Aspirin Tablets BP 300mg Cobalin H Injection 250mcg/m Cobalin H Injection 1000mcg/ml Cobalin Injection 100mcg/ml Cobalin Injection 250mcg/ml Cobalin Injection 500mcg/ml Cobalin Injection 1000mcg/ml Coda-Med Tablets Cod Liver Oil & Creosote Capsules (5 Oval) (R P Scherer) Cod Liver Oil & Creosote Capsules (10 Oval) (R P Scherer) Cod Liver Oil Caps 10 Minims (Woodward) Cod Liver Oil High Potency Capsules (R P Scherer) Cod Liver Oil with Malt Extract and Hypophosphite Syrup (Distillers) Cod Liver Oil 0.3 ml Capsules (R P Scherer) Cod Liver Oil 0.6 ml Capsules (R P Scherer) Codalax Codalax Forte Codanin Analgesic Tablets Codis Soluble Tablets Codural Tablets Cojene Tablets Cold & Influenza Capsules (Regent Laboratories) Cold & Influenza Mixture (Boots) Cold & Influenza Mixture (Davidson) Cold & Influenza Mixture (Rusco) Cold & Influenza Mixture (Thornton & Ross) Cold Relief (Blackcurrant Flavour) Granular Powder (Boots) Cold Relief Capsules (Scott & Bowne) Cold Relief Tablets (Boots) Cold Tablets (Roberts) c SD No. 2005/0727 Page 57

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Coldrex Powder Coldrex Tablets Colgard Emergency Essence (Lane Health Products) Colgate Dental Cream with MFP Fluoride Colgate Disclosing Tablets Collins Elixir Colocynth & Jalap Tablets Compound BPC 1963 Colocynth Compound Pills BPC 1963 Cologel Liquid Communion Wafers Complan Comploment Continus Tablets Compound Fig Elixir BP Compound Rhubarb Oral Powder BP Compound Rhubarb Tincture BP Compound Syrup of Glycerophosphates BPC 1963 Compound Syrup of Hypophosphites BPC 1963 Comtrex Capsules Comtrex Liquid Comtrex Tablets Concavit Capsules Concavit Drops Concavit Injection Concavit Syrup Confiance Dietary Supplement Tablets Congreves Balsamic Elixir Constipation Herb Dried (Potters) Constipation Herbs (Hall’s) Constipation Herbs (Mixed Herbs) (Brome & Schimmer) Constipation Mixture No 105 (Potters) Contac 400 Capsules Contac Coughcaps Contactaclean Cleaning Solution Contactasoak Disinfecting and Soaking Solution Contactasol 02 Care Solution Contactasol Complete Care All-In-One Solution Contactasol Solar Saline Spray Contactasol Wetting Solution Copholco Cough Syrup Copholcoids Coppertone Apres Plage Aftersun Milk Coppertone Children’s Cream SPF25 Coppertone Children’s Lotion SPF15 Coppertone Dark Tanning Lotion SPF4 Coppertone Sun Tanning Lotion SPF6 Coppertone Water Resistant Tanning Cream SPF8 Co-Q10 Tablets Core Level Adrenal Tablets Core Level Auto Sym Tablets Core Level C Timed Release Tablets Core Level Health Reserve Tablets

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Core Level Ilioduodenal Tablets Core Level Magnesium Tablets Core Level Zinc Tablets Corrective Tablets (Ayrton Saunders) Correctol Tablets Cosalgesic Tablets Cosylan Syrup Coterpin Syrup Cough & Bronchitis Mixture (Davidson) Cough & Cold Mixture (Beecham) Cough Balsam (Abernethy’s) Cough Balsam (Thornbers) Cough Expectorant Elixir (Regent Laboratories) Cough Linctus (Sanderson’s) Cough Linctus Alcoholic (Thomas Guest) Cough Linctus for Children (Boots) Cough Medicine for Infants & Children Solution (Boots) Cough Mixture (Tingles) Cough Mixture Adults (Thornton & Ross) Cough Mixture Adults (Wicker Herbal Stores) Cough Syrup Best (Diopharm) Cough Tablets (Kerbina) Country Basket Rice Cakes Covermark Removing Cream Covonia Bronchial Balsam Linctus Cow & Gate Babymeals Stage One Cow & Gate Baby Milk Plus Cow & Gate Follow-On Babymilk Step Up Cow & Gate Junior Meal Cow & Gate Olvarit Stage Two Main Course Cow & Gate Premium Baby Food Cox Pain Tablets Crampex Tablets Cranberry Juice Cream of Magnesia Tablets 300 mg Cremaffin Emulsion Cremalgin Balm Creosote Bronchial Mixture (Loveridge) Crookes One-a-Day Multivitamins with Iron Crookes One-a-Day Multivitamins without Iron Crookes Wheat Germ Oil Capsules Croupline Cough Syrup (Roberts) Crusha Milk Shake Syrup Cullen’s Headache Powders Culpepper Healing Ointment Culpepper Rheumatic Cream Cupal Health Salts Cupal Nail Bite Lotion Cuprofen Soluble Tablets Cuprofen Tablets Cuticura Medicated Foam Bath c SD No. 2005/0727 Page 59

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Cuticura Talcum Powder Cyanocobalamin Solution (any strength) Cytacon Liquid Cytacon Tablets Cytamen 250 Injection Cytamen 1000 Injection Cytoplan Acidophilus Capsules (Milk Free) Cytoplan Acidophilus/Bifidophilus 50%/50% Capsules Cytoplan Aloe Vera Concentrate Cytoplan Betaine & Pepsin Capsules 345 mg/10mg Cytoplan Bifidophilus Extra Tablets Cytoplan Biotin Capsules 100mcg Cytoplan Children’s Chewable Mineral/Vitamin Tablets Cytoplan Choline/Inositol Capsules 250 mg/250mg Cytoplan Co-Factor Compound Plus Capsules Cytoplan Cytocleanse Formula Capsules Cytoplan Cytomin Mineral/Vitamin Tablets Cytoplan Cytophilus Milk Free Capsules Cytoplan Cytoplex Tablets Cytoplan De-Toxifying Compound Capsules Cytoplan Dolomite Magnesium Carbon Calcium Carbon Tablets Cytoplan EPA Capsules Cytoplan Iron Extra Tablets Cytoplan Lecithin Capsules Cytoplan Magnesium Ascorbic Capsules Cytoplan Magnesium/Calcium Capsules 250mg/250 mg Cytoplan Magnesium Citric Capsules Cytoplan Magnesium Complex Capsules Cytoplan Manganese Complex Capsules Cytoplan Multex Multivitamin and Mineral Formulation Cytoplan Pantothenic Acid Tablets Cytoplan Potassium Pantothenate Capsules Cytoplan Pryoxidal-5-pH Complex Capsules Cytoplan Selenium Capsules Cytoplan Supermag-Plus Capsules Cytoplan Vitamin A Capsules Cytoplan Vitamin C 1000 mg + Bioflavour 50mg Capsules Cytoplan Vitamin C Powder Cytoplan Vitamin E Capsules Cytoplan Zinc Lozenge Wafers Dakin’s Golden Vitamin Malt Syrup Daktarin Cream 15g Daktarin Powder Daktarin Twin Pack Dalivit Capsules Dalivit Syrup Dalmane Capsules 15 mg Dalmane Capsules 30 mg Dansac Skin Lotion Davenol Linctus Daxaids Tablets

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Day-Vits Multivitamin & Mineral Tablets Dayovite De Witt’s Analgesic Pills De Witt’s Antacid Powder De Witt’s Antacid Tablets De Witt’s Baby Cough Syrup De Witt’s Cough Syrup De Witt’s PL Pills Dead Sea Natural Mineral Soap Deakin and Hughes Cough and Cold Healer Mixture Deakin’s Fever and Inflammation Remedy Mixture Delax Emulsion Delial Lotion SPF 2 Delial Lotion SPF 6 Water Resistant Delimon Deltasoralen Bath Lotion Dencyl Spansules Derbac C Shampoo Derl Dermatological Soap Dermablend Chromatone Fade Creme Plus Dermablend Cleanser/Remover Dermablend Maximum Moisturiser Dermablend Quick Fix Concealment Stick Dermacort Cream Dentakit Toothache First Aid Kit Dentu-Hold Liquid Derbac Soap Dermacolor Body Cover Dermacolor Cleansing Cream Dermacolor Cleansing Lotion Dermacolor Cleansing Milk Dermacolor 6 Colour Palette Dermacolor Creme Effective No 2 Dermacolor Fixier Spray Dermacolor Skin Plastic Dermacort Cream Dermalex Skin Lotion Dermidex Dermatological Cream Dermo-Care Soapless Soap Desiccated Liver Tablets Desiccated Liver USNF Tablets Detox Tablets (Hursdrex) Dettox Antibacterial Cleanser Dextro Energy Glucose Tablets Dextrogesic Tablets Dextromethorphan Hydrobromide Solution 3.75mg/5 ml Dextromethorphan Hydrobromide Solution 7.5 mg/5 ml Dextromethorphan Hydrobromide Syrup 6.6 mg/5 ml Dextromethorphan Hydrobromide Syrup 13.5 mg/5 ml Dextropropoxyphene & Paracetamol Dispersible Tablets Dextropropoxyphene & Paracetamol Soluble Tablets c SD No. 2005/0727 Page 61

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

DF 118 Elixir DF 118 Tablets DGL 1 Suspension DGL 2 Suspension DGT 1 Tablets DGT 2 Tablets DHL Rheumatic Massage Cream Diabetic Bronal Syrup Dialar Forte Syrup 5 mg/5 ml Dialar Syrup 2 mg/5 ml Dialume Capsules 500 mg Diazepam Capsules, Slow 10 mg Diazepam Elixir 5 mg/5 ml Diazepam Oral Solution 5mg/5ml Diazepam Oral Suspension 5mg/5ml Dietade Diabetic Jam Dietade Diabetic Marmalade Dietade Diabetic Squash Dietade Dietary Foods Fruit Sugar Dietade Fruit Sugar Dietade Jelly Crystals Digesprin Antacid Tablets Digestells Lozenges Dihydroxyaluminium Sodium Carbonate Tablets Dijex Liquid Dijex Tablets Dimotane Expectorant Dimotane Expectorant DC Dimotane with Codeine Elixir Dimotane with Codeine Paediatric Elixir Dimotapp Elixir Dimotapp Elixir Paediatric Dimotapp LA Tablets Dimotapp P Tablets Dimyril Linctus Dinnefords Gripe Mixture Diocalm Ultra Capsules Dioctyl Ear Drops Disprin Direct Tablets Disprin Extra Tablets Disprin Solmin Tablets Disprin Tablets Disprinex Tablets Disprol Infant Suspension Disprol Junior Tablets Soluble Distalgesic Soluble Tablets Distalgesic Tablets Ditemic Spansules Do-Do Linctus Do-Do Tablets Dolasan Tablets Doloxene Capsules

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Doloxene Compound Pulvules Dolvan Tablets Dorbanex Capsules Dorbanex Liquid Dorbanex Liquid Forte Dormonoct Tablets 1 mg Dove Cleansing Bar Dr Brandreth’s Pills Dr D E Jongh’s Cod Liver Oil with Malt Extract & Vitamins Fortified Syrup Dr William’s Pink Pills Dragon Balm Drastin Tablets Dristan Decongestant Tablets with Antihistamine Dristan Nasal Spray Droxalin Tablets Dry Cough Linctus (Scott & Bowne) Dual-Lax Extra Strong Tablets Dual-Lax Tablets Dubam Cream Dubam Spray Relief Dulca Tablets Dulcodos Tablets Dulco-Lax Suppositories Dulco-Lax Tablets Duo-Gastritis Mixture (Baldwin’s) Duphalac Syrup Duralin Capsules Extra Strength Duralin Tablets Dusk Insect Repellent Cream Duttons Cough Mixture Dynese Aqueous Suspension Dynese Tablets D001 Capsules D002 Capsules D004 Capsules D006 Capsules D007 Capsules D009 Capsules D010 Capsules D011 Capsules D012 Capsules D013 Capsules D014 Capsules D017 Capsules D018 Capsules D019 Capsules D020 Capsules D021 Capsules D024 Capsules D029 Capsules c SD No. 2005/0727 Page 63

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

D030 Capsules D031 Capsules D032 Capsules D033 Capsules D034 Capsules D036 Capsules Earex Ear Drops Earthdust Aged Garlic Tablets Earthdust Capricin Forte Capsules Earthdust Formula 1 Capsules Earthdust Pro-Biotic New Complex Powder Earthdust Super-Pro-Bifidus Powder Earthdust Super-Pro-Dophilus Powder Earthlore Vitamin B Compound Tablets Ecdilyn Syrup Ecologic 315 Granules Educol Tablets Efamol Efamol Capsules Efamol Marine Capsules Efamol Oil Efamol PMP Efamol Plus Capsules Efamol Plus Evening Primrose Oil & Coenzyme Q10 Capsules Efamolia Enriched Moisture Cream Efamolia Moisture Cream Efamolia Night Cream Efavite Tablets Efavite Vitamin & Zinc Supplement Tablets Effer-C Tablets Effico Syrup Elagen Eldermint Cough Mixture (Herbal Laboratories) Elgydium Toothpaste Elizabeth Arden Flawless Finish Elizabeth Arden Sunblock Cream Factor 15 Elizabeth Arden Sunscience Superblock Cream spf 34 Elkamol Tablets Ellimans Universal Embrocation Elsan Blue Liquid Emuwash Endet Powders Ener-G Gluten-free and Soya-free Macaroon Cookies Ener-G Gluten-free Rice Peanut-Butter Cookies Ener-G Gluten-free Rice Walnut Cookies Energen Starch Reduced Crispbread Enfamil Human Milk Fortifier English Grains Mixed Gland Compound Tablets English Grains Red Kooga Multivitamins & Minerals Engran HP Tablets Engran Tablets

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Eno Fruit Salts Enzyme Process Achol Tablets Enzyme Process Enzastatin Tablets Enzyme Process Liver Tablets Enzyme Process Pancreas 523 Tablets Enzyme Process Pro-T-Compound Tablets Enzyme Process Vitamin B12 + Liver Tablets EP Tablets EPOC Capsules Equagesic Tablets Equisorb High Fibre Guar Bread Rolls Eskamel Cream Eskornade Spansule Capsules Eskornade Syrup Eso-Col Cold Treatment Tablets Esoterica Fortified Cream Essentia Special E Cream Ester-C Powder Ester-C Tablets Euhypnos Capsules 10 mg Euhypnos Elixir 10 mg/5 ml Euhypnos Forte Capsules 20 mg Evacalm Tablets 2 mg Evacalm Tablets 5 mg Evans Cough Balsam Evening Primrose Oil Evening Primrose Oil Capsules Evian Mineral Water Evident Disclosing Cream Ex-Lax Chocolate Laxative Tablets Ex-Lax Pills Expectorant Cough Mixtures (Beecham) Expulin Cough Linctus Expulin Decongestant Linctus for Babies & Children Expulin Paediatric Cough Linctus Extil Compound Linctus Extravite Tablets Extren Tablets Exyphen Elixir E001 Capsules E015 Capsules E018 Capsules E021 Capsules E031 Capsules E032 Capsules Fade Out Skin Lightening Cream Fairy Household Liquid Falcodyl Linctus Falkamin Fam Lax Tablets Famel Expectorant c SD No. 2005/0727 Page 65

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Famel Linctus Famel Original Linctus Family Cherry Flavoured Linctus (Cupal) Family Health Multivitamin Tablets Family Herbal Pills Fanalgic Syrup Fanalgic Tablets Farex Fingers Farley’s Farex Weaning Food Farley’s First Milk Farley’s Follow-On Milk Farley’s Premcare Ready-to-Feed Farleys Rusks Farley’s Tea Timer Father Pierre’s Monastery Herbs Fe-Cap C Capsules Feac Tablets Feen-a-Mint Tablets Fefol Spansule Capsules Fefol-Vit Spansules Fefol Z Spansule Capsules Femafen Capsules Femerital Tablets Femeron Cream Feminax Tablets Fendamin Tablets Fennings Adult Cooling Powders Fennings Children’s Cooling Powders Fennings Little Healers Pills Fennings Mixture Fennings Soluble Junior Aspirin Tablets Fenox Nasal Drops Fenox Nasal Spray Feospan Spansule Capsules Ferfolic SV Tablets Ferfolic Tablets Fergluvite Tablets Fergon Tablets Ferraplex B Tablets Ferrlecit Tablets/Dragees Ferrocap Capsules Ferrocap F-350 Capsules Ferroglobin B12 Vitamin/Mineral Compound Ferrograd C Tablets Ferrol Ferrol Compound Mixture Ferromyn B Elixir Ferromyn B Tablets Ferrous Gluconate Compound Tablets Ferrous Sulphate Compound Tablets BP Fesovit Spansules

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Fesovit Z Spansules Fibre Biscuits Fibrosine Analgesic Balm Fiery Jack Cream Fiery Jack Ointment Filetti Sensitive Skin Soap Powder Finasteride 1mg Tablets Fine Fare Aspirin Tablets 300 mg Fine Fare Hot Lemon Powders Fink Linusit Gold Pure Golden Linseeds Flar Capsules Flavelix Syrup Flexcare Soft Lens Solution Flexsol Solution Flora Margarine Floradix Formula Liquid Floradix Tablets Floral Arbour Tablets (Cathay) Flucaps Flunitrazepam Tablets 1 mg Fluralar Capsules 15 mg Fluralar Capsules 30 mg Flurazepam Capsules 15 mg Flurazepam Capsules 30 mg Flurazepam Hydrochloride Capsules 15 mg Flurazepam Hydrochloride Capsules 30 mg Flu-Rex Tablets Flurex Bedtime Cold Remedy Flurex Capsules Flurex Decongestant Inhalant Capsules Flurex Hot Lemon Concentrate Flurex Tablets Folex-350 Tablets Folicin Tablets Folped Foresight Tablets Mineral Formula Foresight Tablets Vitamin (Multivitamins) Formula M.E. (Multiple Elevator) No 1 Capsules Formula M.E. (Multiple Elevator) No 2 Capsules Formula M.E. (Multiple Elevator) No 3 Capsules Formule B Spot Treatment Roll On Formulix Forprin Tablets Fortagesic Tablets Fortespan Spansules Fort-E-Vite Capsules Fort-E-Vite 1000 Capsules Fort-E-Vite Cream Fort-E-Vite Plus Capsules Fort-E-Vite Super Plus Capsules Fortison Low Sodium c SD No. 2005/0727 Page 67

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Fortral Capsules 50 mg Fortral Injection Fortral Suppositories Fortral Tablets 25 mg Fortral Tablets 50 mg Fortris Solution Fosfor Syrup Franol Expectorant Franolyn Sed Liquid Frisium Capsules 5 mg Frisium Capsules 10 mg Frisium Capsules 20 mg FSC Betaine HCL Capsules FSC Beta Plus Capsules FSC Evening Primrose Oil + Vitamin E Cream FSC Lactobacillus Acidophilus Capsules FSC Multivitamin Addlife For Over 50s Capsules FSC Natural Vitamin E Capsules FSC Organic Linseed Oil Capsules FSC Super B-Supreme High-Potency Tablets FSC Super Calcium 200 mg + Vitamin A & D Tablets FSC Vitamin B6 Tablets FSC Vitamin D 400u Fybranta Tablets Fynnon Calcium Aspirin Tablets Fynnon Salt G Brand Linctus Galake Tablets Gale’s Honey Galfer-Vit Capsules Galloway’s Baby Cough Linctus Galloway’s Bronchial Cough Care Galloway’s Bronchial Expectorant Galloway’s Cough Syrup Gammolin Capsules Gamophase Gamolenic Acid Capsules Gamophen Gastalar Tablets Gastric Ulcer Tablets No 1001 Gastrils Pastilles Gastritabs Gastrovite Tablets Gatinar Syrup Gaviscon Granules Gaviscon 250 Tablets Gelusil Lac Powder Gelusil Tablets Genasprin Tablets Genatosan Gentian Acid Mixture with Nux Vomica Gentian Alkaline Mixture with Nux Vomica

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Gentian & Rhubarb Mixture BPC Georges Vapour Rub Ointment Gericaps Capsules Gericare Multivitamin & Mineral Capsules Gerimax Original Korean Panax Ginseng with Vitamins, Minerals and Amino Acid Geriplex Capsules Germolene Ointment Gevral Capsules Gevral Tablets Ginkgo Biloba Extract Capsules 40 mg Ginkgo Biloba Liquid Givitol Capsules Gladlax Tablets Glemony Balsam (Baldwin’s) Glenco Elixir Gluca-Seltzer Effervescent Powder Glucodin Glutafin Gluten-Free Chocolate Chip Cookies Glutafin Gluten-Free Custard Cream Biscuits Glutafin Gluten-Free Gingernut Cookies Glutafin Gluten-Free Milk Chocolate Biscuits Glutafin Gluten-Free Milk Chocolate Digestive Biscuits Glutafin Gluten-Free Shortcake Biscuits Glutano Gluten-Free Chocolate Hazelnut Wafer Bar Glutano Gluten-Free Muesli Glutano Gluten-Free Pretzel Glutano Gluten-Free Wafer Glutano Gluten-Free Wafer, Cream Filled Glycerin Honey & Lemon Cough Mixture (Isola) Glycerin Honey & Lemon Linctus (Boots) Glycerin Honey & Lemon Linctus with Ipecacuanha (Boots) Glycerin Lemon & Honey and Ipecacuanha (Thomas Guest) Glycerin Lemon & Honey Linctus (Rusco) Glycerin Lemon & Honey Syrup (Cupal) Glycerin Lemon & Honey Syrup (Thomas Guest) Glycerin Lemon & Honey Syrup (Waterhouse) Glycerin Lemon & Ipecacuanha Cough Mixture (Isola) Glykola Infants Elixir Glykola Tonic Glymiel Hand Care Goat’s Milk Spray Dried Powder Goddards White Oils Embrocation Golden Age Vitamin and Mineral Capsules Golden Health Feverfew Tablets Golden Health Super Sea Kelp Tablets Golden Health Tablets (Kerbina) Golden Health Tablets (Brome & Schimmer) Gon Tablets Gonfalcon Tablets Grangewood Insomnia Tablets c SD No. 2005/0727 Page 69

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Granogen Granose Liquid Soya Milk Granose Soya Yogert Granoton Emulsion Gratis Gluten-Free Tricolour Pasta Gregovite C Tablets GS Tablets Guaiphenesin Syrup (any strength) Guanor Expec torant Gynovite Plus Nutritional Supplement Tablets H-Pantoten Tablets Hactos Chest & Cough Mixture (Thomas Hubert) Halaurant Syrup Halcion Tablets 0.125 mg Halcion Tablets 0.25 mg Haliborange Syrup Haliborange Tablets Halibut Liver Oil A & D Capsules (Rodale) Halibut Oil A & D Capsules (GR Lane Health Products) Halin Tablets Halocaps Inhalant Capsules Halycitrol Emulsion Harvestime Malt Extract with Cod Liver Oil and Butterscotch Hayphryn Nasal Spray HC45 Cream Head and Shoulders Shampoo Health Aid Children’s Multivitamin + Mineral Tablets Health Aid DL-Phenylalanine Tablets 500 mg Health Aid Dolomite Tablets Health Aid Eczema Oil Health Aid EPO Forte Capsules 1000 mg Health Aid Halibut Liver Oil Capsules Health Aid Magnesium & Calcium Tablets Health Aid Multivitamins & Minerals Tablets Health Aid Super Cod Liver Oil Capsules Health Aid Super Lecithin Capsules Health Aid Vitamin A Capsules Health Aid Vitamin A + D Capsules Health Aid Vitamin B6 Tablets Prolonged Release Health Aid Vitamin B Complex Supreme Tablets Health Aid Vitamin C Tablets Health Aid Vitamin E Capsules Health Aid Vitamin E Cream Health Aid Vitamin E Hand and Body Lotion Health Aid Vitamin E Natural Capsules Health Aid Vitamin E Oil Health Aid Zinc Sulphate Tablets 200 mg Health Aid Zinc Tablets 10 mg Health+Plus Absorb Plus Capsules Health+Plus Absorb Plus Tablets

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Health+Plus Chromium GTF & B3 Tablets Health + Plus Complex B Tablets Health+Plus Co-Q Plus Tablets Health+Plus Dolomite + D Tablets Health+Plus E500 Tablets Health+Plus Immunade Tablets Health+Plus Multiminerals Tablets Health+Plus Multivite Tablets Health+Plus Nutrient Pack, Metabolic Pack Health+Plus Pregnancy Pack Health+Plus Selenium Tablets 50mcg Health+Plus Super B6 + Zinc Tablets Health+Plus Super C1000 Tablets + Bioflavour Health+Plus Supercholine Tablets Health+Plus Vitamin E Capsules High-Potency Health+Plus VV Pack Health+Plus Ziman Plus (Manganese & Zinc) Tablets Health Salts (Wicker Herbal Stores) Health Tonic Mixture (Hall’s) Healthaid Glucosamine Sulphate Tablets Healthcrafts Aminochel Calcium Tablets Healthcrafts Aminochel Chelated Magnesium Tablets Healthcrafts Aminochel Zinc Tablets 1.3 mg Healthcrafts Aminochel Zinc Tablets 5 mg Healthcrafts Arteroil Tablets Healthcrafts Betacarotene Capsules Healthcrafts Brewers Yeast Tablets Healthcrafts Calcium + Vitamin D Chewable Tablets Healthcrafts Calcium Chewable Tablets Healthcrafts Calcium Pantothenate Super Tablets Healthcrafts Cod Liver Oil Capsules Healthcrafts Cod Liver Oil Compleat Tablets Healthcrafts Dolomite Tablets 500 mg Healthcrafts EPA Forte Capsules Healthcrafts High Strength Starflower Oil Healthcrafts Kelp Tablets Healthcrafts Lecithin Capsules Healthcrafts Multivitamin Chewable Tablets Healthcrafts Multivitamin + Iron & Calcium Tablets Healthcrafts Natural Vitamin C 1g Tablets (High Potency) Healthcrafts Prolonged Release Nutrition Mega-B6 Tablets Healthcrafts Prolonged Release Nutrition Mega B-Complex Tablets Healthcrafts Prolonged Release Nutrition Mega C 1500 Tablets Healthcrafts Prolonged Release Nutrition Mega Multis Tablets Healthcrafts Vitamin E Capsules Healthcrafts Vitamin E Capsules High-Potency Healthcrafts Vitamin E Capsules Mega Healthcrafts Vitamin E Capsules Super Healthcrafts Vitamin E Natural Oil Healthcrafts Vitamin E One-A-Day Capsules Healthcrafts Zinc One-A-Day Capsules c SD No. 2005/0727 Page 71

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Healtheries Rice Crispbread Healthilife Dolomite Tablets 60 mg Healthilife Halibut Oil Capsules Healthilife Rutin Tablets 60 mg Healthilife Sunflower Seed Oil Capsules 500 mg Healthilife Vitamin A Capsules Healthilife Wild Sea Kelp Tablets 300 mg Healthlink High Zinc + Manganese Formula 1 Capsules Healthlink Loosemore Herbal Capsules Healthlink Magnesium Acetate Capsules Healthlink Psyllium Husks Healthwise Halibut Oil Capsules Healthwise Vitamin E Capsules Healthilife Vitamin E Soya Free Capsules Health Perception Glucosamine Tablets Heart Shape Indigestion Tablets Heath & Heather Feverfew Tablets Heath & Heather Garlic Perles (Odourless) Hedamol Capsules Hedex Extra Caplets Hedex Plus Capsules Hedex Seltzer Granules Hedex Soluble Granules Hedex Tablets Heinz Weight Watcher Baked Beans Hemingways Catarrh Syrup Hemoplex Injection Hepacon B12 Injection Hepacon Liver Extract Injection Hepacon B-Forte Injection Hepacon-Plex Hepanorm Tablets Herbal Aperient Tablets (Cathay) Herbal Aperient Tablets (Kerbina) Herbal Bronchial Cough Tablets (English Grains) Herbal Laboratories Feverfew Tablets Herbal Laxative Naturtabs Herbal Pile Tablets Herbal Quiet Nite Sleep Naturtabs Herbal Syrup (Baldwin’s) Herbalene Herbs Hermesetas (blue) Hermesetas Gold Hermesetas Light Hermesetas Liquid Sweetener Hermesetas Sprinkle Sweet Hexidin Solution Hi-g-ah Tea Higher Nature Paraclear Capsules Hi-pro Liver Tablets Hill’s Adult Balsam

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Hill’s Balsam Children’s Mixture for Chesty Coughs Hip C Rose Hip Syrup Hismanal Tablets 10-tablet pack Histalix Expectorant Hofels Cardiomax Garlic Pearles Hofels Garlic Pearles Hofels One-A-Day Garlic Pearles Hofels One-A-Day Neo Garlic Pearles Honey & Molasses Cough Mixture (Lane Health Products) Hot Blackcurrant Cold Remedy (Beechams) Hot Lemon Cold Remedy (Beechams) Hot Lemon Cold Treatment (Scott & Bowne) Hot Measure Solution (Reckitt & Colman) Hydrex Hand Rub Hydrocare Boiling/Rinsing Solution Hydrocare Cleaning and Soaking Solution Hydrocare Preserved Saline Solution Hydrocare Protein Remover Tablets Hydroclean Solution Hydron Europe Cleaning Solution Hydron Europe Comfort Soaking Solution Hydron Europe Solusal Hydron Europe Solution Comfort Hydrosoak Disinfecting and Soaking Solution Hydrosol Comfort Solution Hymosa Vitamin E Cream Hypomultiple Capsules Hypon Tablets Iberet 500 Tablets Iberol Tablets Ibrufhalal Tablets ICC Analgesic Tablets Idoloba Tablets Iliadin Mini Nasal Drops Iliadin Mini Paediatric Nasal Drops Imarale Agba Suspension Imarale Omode Suspension Imedeen Skin Regenerating Tablets Imedeen Tablets Imodium Capsules Pharmacy Packs 8 and 12 capsules Importal Imuderm Body Wash Imuderm Hand & Face Wash Imuderm Shower Gel Inabrin Tablets 200 mg Indian Brandy Solution Indigestion Mixture (Boots) Indigestion Mixture (Thornton & Ross) Indigestion Mixture (William Ransom) Indigo Indigestion Lozenges Infaderm Baby Bath c SD No. 2005/0727 Page 73

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Infaderm Baby Cream Infaderm Baby Hair Wash Infaderm Baby Lotion Infa-Care Baby Bath Influenza and Cold Mixture 2315 (Wright Layman & Umney) Inhalit Liquid Inhalation Innoxa Concealing Cream Innoxa Creme Satin Foundation Innoxa Finishing Touch Loose Powder Innoxa Foundation Innoxa Moisturised Liquid Make-Up Innoxa Sensitive/Dry Range: Enriched Moisture Cream Innoxa Sensitive/Normal Range: Creamy Moisturiser Innoxa Young Solution Spot Gel Inoven Caplets Iodinated Glycerol Elixir 60 mg/5 ml Iodised Vitamin Capsules Iodo-Ephedrine Mixture Ionax Scrub Ipecacuanha Pills 20 mg Ipecacuanha & Morphine Mixture BP Ipecacuanha & Squill Linctus Paediatric BPC Ipsel Hygienic Babysalve Irofol C Iron & Brewers Yeast Tablets (3M Health Care) Iron and Vitamin Tablets (Davidson) Iron Formula Tablets (Rodale) Iron Jelloids Tablets Iron Tonic Tablets (Boots) Ironorm Capsules Ironorm Tonic Ironplan Capsules Isoaminile Linctus Isocal Ivy Tablets (Ayrton Saunders) Jaap’s Health Salts Jacksons All Fours Cough Mixture Jacksons Febrifuge Jambomins Tablets Jenners Suspension Jenners Tablets Jochem Hormone Hair Preparation Johnson & Johnson Baby Bath Johnson & Johnson Baby Cream Johnson & Johnson Baby Lotion Johnson & Johnson Baby Oil Johnson & Johnson Baby Powder Johnson & Johnson Baby Shampoo Johnson & Johnson Baby Sunblock Stick Johnson & Johnson Prickly Heat Powder Jolen Creme Bleach

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Jordans Crunchy Bar Junamac Jung Junipah Tablets Jungle Formula Insect Repellent Gel Jungle Formula Insect Repellant Pump Spray Junior Cabdrivers Linctus Junior Disprin Tablets Junior Disprol Tablets Junior Ex-Lax Chocolate Tablets Junior Lemsip Powder Junior Meltus Cough & Catarrh Linctus Junior Mucron Liquid Junior Paraclear Tablets Junior Tablets (Rodale) Juno-Junipah Mineral Salts Juvel Elixir Juvel Tablets Juvela Gluten-Free Mince Pies Jevela Gluten-Free Sage & Onion Stuffing Mix Juvela Low-Protein Savoury Snack Kamillosan Baby Cleansing Bar K’An Herbal Preparations Kaodene Suspension Kaopectate Karvol Capsules Kelsoak 2 Solution Kelvinol 2 Wetting Solution Kenco Instant Decaffeinated Coffee Kendales Adult Cough Syrup Kendales Cherry Linctus Kentogam Gamolenic Acid Capsules Kest Tablets Ketazolam Capsules 15 mg Ketazolam Capsules 30 mg Ketazolam Capsules 45 mg Keybells Linctus of Glycerine, Lemon & Ipecacuanha Kingo Cough Syrup Koladex Tablets Kolanticon Tablets Kolanticon Wafers Kolantyl Gel Kolorex Capsules Kolynos Denture Fixative Krauses Cough Linctus Kruschen Salts Kuralax Herbs Kwai Garlic Tablets Kylie Skin Guard Labiton Kola Tonic Laboprin Tablets Lac Bismuth Mixture c SD No. 2005/0727 Page 75

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Lactaid Lactase enzyme for milk drops Lactaid Lactase enzyme tablets Lactaid Lactose reduced skimmed and whole milk UHT Lacto Calamine Ladycare No 2 (Menopausal) Tablets Laevoral Lamberts Acidophilus Extra Capsules Lamberts Bee Propolis Tablets Lamberts Beta Carotene Capsules Lamberts Betaine HCL/Pepsin Tablets Lamberts Betasec Tablets Lamberts Betasec Timed Release Antioxidant Tablets Lamberts Calcium Extra Tablets Lamberts Calcium/Magnesium Balance Capsules Lamberts Calcium & Magnesium Chelates Tablets Lamberts Calcium 500/Magnesium 250 Amino Acid Chelated Tablets Lamberts Calcium/Magnesium/Zinc Orotates Capsules Lamberts Caprylic Acid Tablets Lamberts Chelating Mega Mineral Complex Tablets Lamberts Co-Enzyme Q10 Capsules Lamberts DLPA Complex + Vitamin B & C Capsules Lamberts Dolomite Tablets Lamberts Enzygest Capsules Lamberts EPA Marine Lipid Concentrate Capsules Lamberts Evening Primrose Oil 250 mg Capsules Lamberts Evening Primrose Oil 500 mg Capsules Lamberts Evening Primrose Oil 1000 mg Capsules Lamberts Gentle Vitamin C Tablets Lamberts Ginkgo Biloba Extract Tablets Lamberts Glucosamine Sulphate Tablets Lamberts GTF Chromium Capsules Lamberts Health Insurance Plus Tablets Lamberts High Potency EPA Capsules Lamberts L-Carnitine Capsules Lamberts L-Carnitine Tablets Lamberts L-Glutamic Acid Powder Lamberts L-Glutamine Capsules Lamberts L-Glutathione Complex Capsules Lamberts L-Histidine HCL Capsules Lamberts L-Isoleucine Capsules Lamberts L-Leucine Capsules Lamberts L-Threonine 500 mg Capsules Lamberts Magnesium Amino Acid Chelated Tablets Lamberts Magnesium Orotate Capsules Lamberts Magnesium Sustained Release Tablets Lamberts Magnesium Sustained Release Timed Release Tablets Lamberts Mega Mineral Compound Tablets Lamberts Mega 3 Vitamins/Minerals Tablets Lamberts Multi-Max Tablets Lamberts Natural Vitamin E Capsules Lamberts One Daily Vitamin/Mineral Tablets

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Lamberts Playfair Tablets Lamberts PMT Supplement Optivite Tablets Lamberts Protein Deficiency Formula Capsules Lamberts Protein Deficiency Formula Powder Lamberts Pycnogenol Capsules Lamberts Pyridoxal-5-Phosphate Capsules Lamberts Pyridoxal-5-Phosphate Plus Capsules Lamberts Selenium Capsules Lamberts Selenium Tablets Lamberts Senior Capsules Lamberts Super Acidophilus Plus Capsules Lamberts Taurine Capsules Lamberts Ultra Detoxifying Capsules Lamberts Vitamin B-50 Complex Capsules Lamberts Vitamin B-50 Complex Tablets Lamberts Vitamin B-100 Complex Tablets Lamberts Vitamin C Ascorbic Acid & Calcium Ascorbate Crystals Lamberts Vitamin C Ascorbic Acid Powder Lamberts Vitamin C & Bioflav Tablets Lamberts Vitamin C Calcium Ascorbate Crystals Lamberts Vitamin C-Time Bioflav Timed-Release Tablets Lamberts Vitamin E 200 D-Alpha Tablets Lamberts Vitamin E 200 D-Alpha/Selenium Tablets Lamberts Vitamin E 400 D-Alpha/Selenium Tablets Lamberts Vitamin/Mineral Compound Tablets Lamberts Zinc Citrus Capsules Lamberts Zinc Gluconate Tablets Lamberts Zinc Tablets Lanacane Cream Lanacort Cream Lanacort Ointment Lance B & C Tablets Lane’s Cut-a-Cough Lane’s Laxative Herb Tablets Lane’s Sage and Garlic Catarrh Remedy Lanes Glanolin Capsules 250/500 Lanes Lecigran Granules Lantigen B Larkhall Acidophilus 500 Tablets Larkhall B13 Zinc Tablets Larkhall Beta Carotene Capsules Larkhall Calcimega 500 Tablets Larkhall DLPA 375 Tablets Larkhall Dolomite Tablets Larkhall Folic Acid Tablets 100mcg Larkhall Folic Acid Tablets 500mcg Larkhall L-Carnitine Capsules Larkhall Magnesium Orotate B13 Tablets Larkhall Selenium Supplement Tablets Larkhall Vitamin C Naturtabs 1000mg Buffered Lavender Bath c SD No. 2005/0727 Page 77

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Laxaliver Pills Laxatabs Leoren Laxipurg Tablets Laxoberal Elixir LC 65 Cleaning Solution Lecithin Capsules Ledercort Cream Lederplex Capsules Lederplex Liquid Lejfibre Biscuit Lemeze Cough Syrup Lemon Eno Powder Lemon Flu-Cold Concentrated Syrup Lemon Glycerine & Honey Cough Syrup Compound (Carter Bond) Lemon Glycerine & Honey Lung Mixture (Whitehall Laboratories) Lemon Glycerine & Ipecac Cough Syrup Compound (Carter Bond) Lemon Juice, Glycerine & Honey A S Syrup (Ayrton Saunders) Lemon Linctus 1-472 Lem-Plus Capsules Lem-Plus Hot Lemon Drink Lemsip Expectorant Lemsip Flu Strength Lemsip Flu Strength Night Time Formula Lemsip Lemcaps Cold Relief Capsules Lemsip Linctus Lemsip Powder Lendormin Tablets 0.125 mg Lendormin Tablets 0.25 mg Lensept Solution Lensine 5 All in One Solution Lensplus Sterile Saline Spray Lensrins Solution Leoren Tonic Tablets Lexotan Tablets 1.5 mg Lexotan Tablets 3 mg Lexotan Tablets 6 mg Libraxin Tablets Librium Capsules 5 mg Librium Capsules 10 mg Librium Tablets 5 mg Librium Tablets 10 mg Librium Tablets 25 mg Librofem Tablets Lifeplan Acidophilus Capsules Lifeplan Boron 3 Tablets Lifeplan Cod Liver Oil One-A-Day Capsules Lifeplan DL-Phenylalanine (DLPA) Tablets 500 Lifeplan Dolomite Tablets 500 mg Lifeplan Dolomite Tablets 800 mg Lifeplan Dolomite (Natural) Tablets Lifeplan Super Galanol Starflower Capsules

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Lifeplan Vitamin B6 Tablets Lightning Cough Remedy Solution (Potters) Limbitrol Capsules “5” Limbitrol Capsules “10” Linctifed Expectorant Linctifed Expectorant Paediatric Linctoid C Linituss Linoleic Acid Linus Vitamin C Powder Lipoflavonoid Capsules Lipotriad Capsules Lipotriad Liquid Liqufruta Blackcurrant Cough Medicine Liqufruta Honey & Lemon Cough Medicine Liqufruta Medica Liqufruta Medica Garlic Flavoured Cough Medicine Liquid Formula (Food Concentrate) (Rodale) Liquid Paraffin & Phenolphthalein Emulsion BP Liquid Paraffin Emulsion with Cascara BPC Liquifilm Wetting Solution Listerine Antiseptic Mouthwash Listermint Mouthwash Liver Herbs (Hall’s) Livibron Mixture Lloyds Cream (Odour Free) Lloyds Heat Spray Loasid Tablets Lobak Tablets Lofthouse’s Original Fisherman’s Friend Honey Cough Syrup Logado London Herb and Spice Herbal Tea Bags Loramet Capsules 1 mg Loramet Tablets 0.5 mg Loramet Tablets 1 mg Lotil Facial Cream Lotussin Cough Syrup L-Threonine Capsules L-Threonine Tablets Luma Bath Salts Lung Balsam (Rusco) Lyons Ground Coffee Beans Lypsyl Lemon Lypsyl Mint Lypsyl Original Lysaldin M & B Children’s Cough Linctus MA4 Herbal Fruit Concentrate Paste MA572 Tablets Maalox Concentrate Suspension c SD No. 2005/0727 Page 79

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Maalox Plus Tablets Mackenzies Smelling Salts Maclean Indigestion Power Maclean Indigestion Tablets Macleans Toothpaste Magaldrate Tablets Magnesium Citrus Tru-Fil Capsules Magnesium Glycerophos Tablets Magnesium OK Tablets Mainstay Pure Cod Liver Oil Male Gland Double Strength Supplement Tablets Male Sex Hormone Tablets (Diopharm) Malinal Plus Tablets Malinal Suspension 500 mg/5 ml Malinal Tablets 500 mg Malt Extract with Cod Liver Oil & Chemical Food (Distillers) Malt Extract with Cod Liver Oil BPC & Hypophosphites (Distillers) Malt Extract with Cod Liver Oil BPC Soft Extract (Jeffreys Miller) Malt Extract with Haemoglobin & Vitamins Syrup (Distillers) Malt Extract with Halibut Liver-Oil Syrup (Distillers) Malvern Water Mandarin Tablets Manna Herbal Rheumapainaway Tablets Marly Skin Marvel Matthew Cough Mixture Maturaplus Tablets Maws Sterilising Tablets Max Factor Face Powder Max Factor Pan-Stik Maxivits Tablets Medathlon Aspirin Tablets 300 mg Medazepam Capsules 5 mg Medazepam Capsules 10 mg Medex Elixir Mediclean Soft Lens Solution Medilax Tablets Medinol Over 6 Paracetamol Oral Suspension Medinol Under 6 Paracetamol Junior Suspension Medipain Tablets Medised Suspension Medised Tablets Medisoak Soft Lens Solution Meditus Syrup Medocodene Tablets Meggeson Dyspepsia Tablets Melissin Syrup Melo Brand Glycerin Lemon and Honey with Ipecac Meloids Lozenges Meltus Adult Dry Cough Elixir Meltus Adult Expectorant

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Meltus Baby Cough Linctus Meltus Honey and Lemon Cough Linctus Meltus Junior Expectorant Memo Boost Capsules Menopace Capsules Menthacol Liquid Menthells Pellet/Pill Menthol & Benzoin Inhalation BP Menthol & Eucalyptus (M in P) Pastilles (Thomas Guest) Menthol Inhalation Mentholated Balsam (Loveridge) Mentholated Balsam (Savory & Moore) Mentholated Balsam (Wright Layman & Umney) Mentholated Balsam Mixture (Pilsworth Manufacturing) Mentholatum Balm Mentholatum Deep Freeze Spray Mentholatum Deep Heat Maximum Strength Rub Mentholatum Deep Heat Massage Liniment Mentholatum Deep Heat Rub Mentholatum Nasal Inhaler Mercurochrome Solution Metatone Micaveen Midro-Tea Powder Migrafen Tablets Mijex Cream Milgard Baby Cleansing Milk Milk of Magnesia Tablets Mil-Par Suspension Milton Sterilising Tablets Milumil Baby Milk Milupa 7 Cereal Breakfast Milupa Aptamil Baby Milk Milupa Braised Steak & Vegetable Infant Food Milupa Camomile Infant Drink Milupa Cauliflower Cheese Special Infant Food Milupa Country Chicken & Vegetable Casserole Milupa Fennel Variety Infant Drink Milupa Forward Follow-On Milk Milupa Harvest Muesli Breakfast Milupa Infant Dessert, Banana & Apple Yoghurt Milupa Infant Dessert, Caribbean Fruit Milupa Infant Dessert, Semolina & Honey Milupa Infant Tea-Time, Cheese & Tomato Milupa Modified Yoghurt Milupa Special Formula HN25 Milupa Sunshine Orange Breakfast Milupa Vegetable Hotpot Infant Food Minadex Chewable Vitamin Tablets Minadex Syrup Minamino Syrup c SD No. 2005/0727 Page 81

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Minivits Tablets Minoxidil Cream Minoxidil Lotion Minoxidil Ointment Minoxidil Solution (for external use) Mira Flow Cleaning Solution Mira Flow Soft Lens Solution Mira Soak Lens Soaking Solution Mira Sol Soft Lens Solution Mitchell’s Wool Fat Soap Modifast Nutritionally Complete Supplemented Fasting Formula Mogadon Capsules 5 mg Mogadon Tablets 5 mg Moorland Indigestion Tablets Morning Glory Tablets Morny Lavender Talc Mosquito Milk Mosquito Repellent Tropical Formula Mrs Cullen’s Lemsoothe Powder Mrs Cullen’s Powders Mu-Cron Junior Syrup Mu-Cron Tablets Mucofalk Sachets Mucolex Syrup Mucolex Tablets Mucron Liquid Muflin Linctus Multi-Vitamin Tablets (English Grains) Multivitamin Capsules (Regent Laboratories) Multivitamin Tablets (Approved Prescription Services) Multivitamin Tablets (Chemipharm) Multivitamin Tablets (Evans Medical) Multivitamin Tablets (UAC International) Multivitamin with Mineral Capsules (Potters) Multivitamin with Minerals Tablets (Chemipharm) Multivite Pellets Multone Tablets My Baby Cough Syrup Mycocidin Perles Mycolactine Tablets Mylanta Liquid Mylanta Tablets Myolgin Tablets N Tonic Syrup (Cupal) N-300 Capsules Nair Depilatory Cream Nanny Goat’s Milk Infant Formula Napca Skin Lotion Napisan Nappy Treatment Napoloids Tablets Napsalgesic Tablets Nasal Drops for Children (Boots)

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Natex 12A Tablets Natural Bran Natural Flow Acidophilus Capsules Natural Flow Amino Acid Complex Capsules Natural Flow Animal Fun Children’s Chewable Tablets Natural Flow Boron + Calcium & Silica Tablets Natural Flow Calcium Ascorbate Tablets Natural Flow Calcium & Magnesium Chelated Tablets Natural Flow Candiforte Capsules Natural Flow Digestive Enzyme Compound Tablets Natural Flow Dolomite + A & D Tablets Natural Flow Mega B Complex Tablets Natural Flow Mega Multi Tablets Natural Flow Multimineral Tablets Natural Flow Organic Germanium Capsules Natural Flow Primedophilus Powder Natural Flow Probion Bifidus Powder Natural Flow Probion Tablets Natural Flow Psyllium Husks Natural Flow Psyllium Husk Capsules Natural Flow Selenium Chelated Tablets Natural Flow Selenium Tablets Natural Flow Super Vitamin C Complex Tablets Natural Flow Super Vitamin C Tablets Natural Flow Tangerine C Chewable Tablets Natural Flow Thiamin Tablets (Vitamin B1) Natural Flow Vega Mins Tablets Natural Flow Vitamin A Tablets Natural Flow Vitamin C Powder Natural Flow Zinc Chelated Tablets Natural Herb Laxative Tablets (Brome & Schimmer) Natural Herb Laxative Tablets (Kerbina) Natural Herb Tablets (Dorwest) Natural Herb Tablets (Kerbina) Natural Herb Tablets (Lane) Naturavite Tablets Nature’s Aid Co-Enzyme Q-10 Capsules Nature’s Own Acidophilus Plus Capsules (Supreme) Nature’s Own Betacarotene Capsules Nature’s Own Betacarotene Tablets Nature’s Own Calcium Orotate Tablets Nature’s Own Dolomite Tablets Nature’s Own Dolomite-Calcium Carbonate Magnesium Carbonate Tablets Nature’s Own Food State Beta Carotene Tablets Nature’s Own Food State Calcium Tablets Nature’s Own Food State “Euro Formula” Vitamin B Complex + Vitamin C & Magnesium Tablets Nature’s Own Food State Magnesium Tablets Nature’s Own Food State Selenium Tablets Nature’s Own Food State Vitamin B6 (Pyridox) Tablets c SD No. 2005/0727 Page 83

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Nature’s Own Food State Vitamin C Tablets Nature’s Own Food State Vitamin E 300 Tablets Nature’s Own Food State Zinc/Copper Tablets Nature’s Own Multi-Vitamin Tablets Nature’s Own Vitamin B Complex Plus Tablets High Potency Nature’s Own Vitamin B6 (Pyridox) Tablets Nature’s Own Vitamin C Ascorbic Acid Powder Nature’s Own Vitamin C as Calcium Ascorbate Tablets Nature’s Own Vitamin C (as Sodium Ascorbate) Tablets Nature’s Own Vitamin C with Bioflavonoids Nature’s Own Vitamin E 100 Capsules Nature’s Own Vitamin E 100 Emulsifying Capsules Nature’s Own Vitamin E 200 Capsules Nature’s Own Zinc Orotates Nature’s Plus Calcium/Magnesium Tablets Nature’s Plus Green Magma Powder Nature’s Plus Liquid B Complex & Iron Nature’s Plus Mega C Tablets Nature’s Plus Rutin Tablets 500mg Nature’s Plus Super B50 Capsules Naturtabs Choline Naturtabs Nicotinamide Naturtabs Nicotinic Acid Naturtabs Paba Natusan Baby Ointment Naudicelle Nella Red Oil Neo-Cytamen Injection 250 mcg/ml Neo-Cytamen Injection 1000 mcg/ml Neoklenz Powder Neophyrn Nasal Drops Neophyrn Nasal Spray Nescafe Instant Coffee Nestle Nativa HA Nethaprin Expectorant Neuro Phosphates Neurodyne Capsules Neutradol Concentrated Air Deodoriser Neutradonna Powder Neutradonna Sed Powder Neutradonna Sed Tablets Neutradonna Tablets Neutrogena Body Oil (Scented and Unscented) Neutrogena Conditioner Neutrogena Hand Cream Neutrogena Lip Care Neutrogena Liquid Neutrogena Moisture Neutrogena Norwegian Formula Body Emulsion Neutrogena Rainbath Shower and Bath Gel Neutrogena Shampoo

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Neutrogena Soap Neutrogena Sun Care Lotion SPF 14 Neutrolactis Tablets New Formula Beechams Powders Capsules New Life Herbs New Life Tablets Newton’s Children’s Cough Treatment Newton’s Cough Mixture for Adults Nezcaam Syrup Nezeril Nose Drops (single dose pipette) Nicobrevin Niferex 150 Capsules Nilbite Nirolex Expectorant Linctus Nitrados Tablets 5 mg Nitrazepam Capsules 5 mg Nivea No 177 Tablets (Leoren) Nobacter Medicated Shaving Foam Nobrium Capsules 5 mg Nobrium Capsules 10 mg Nocold Tablets Noctamid Tablets 0.5 mg Noctamid Tablets 1 mg Noctesed Tablets 5 mg Noradran Bronchial Syrup Norgesic Tablets Normax Capsules Normison Capsules 10 mg Normison Capsules 20 mg Norvits Syrup Noscapine Linctus BP Nourkrin Tablets Novaprin Tablets Novasil Antacid Tablets Novasil Antacid Viscous Suspension Noxzema Medicated Skin Cream Nucross Coconut Oil Nulacin Tablets Numark Multivitamin Tablets Nurodol Tablets Nurofen Soluble Tablets Nurofen Tablets 200 mg Nurse Sykes Bronchial Balsam Nurse Sykes Powders Nu-Soft Baby Oil Nutricare Beta Carotene Capsules Nutricare Capricin Capsules Nutricare Selenium Tablets Nutricare Vitamin C Tablets Nutricare Zinc Orotate Tablets c SD No. 2005/0727 Page 85

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

NutriTec Vitamin Mineral Complex Food Supplement Nutrition Associates Beta Carotene Capsules Nutrition Associates Reduced Glutathione Capsules Nux Vomica Acid Mixture Nux Vomica Alkaline Mixture Nux Vomica Elixir BPC Nylax Tablets Nytol Tablets Octovit Tablets Ocuvite Multivitamin & Mineral Tablets Oilatum Bar Oilatum Soap Olbas Oil Omeiri Iron Tonic Tablets Omilcaf Suspension Onadox 118 Tablets One Gram C Capsule Opas Powder Opas Tablets Opobyl Bailly Pills Optivite Tablets Oral B Plaque Check Disclosing Tablets Orange and Halibut Vitamins (Kirby Warrick Pharmaceuticals) Organidin Elixir Organidin Solution Organidin Tablets Original Indigestion Tablets (Boots) Orovite 7 Orovite Elixir Orovite Tablets Orthoxicol Syrup Osteocare Calcium & Magnesium Tablets Ostermilk Complete Formula Ostermilk Two Milk Powder Osterprem Otrivine Nasal Drops 0.05% Otrivine Nasal Drops 0.1% Otrivine Nasal Spray 0.1% Otrivine-Antistin Nasal Drops Otrivine-Antistin Nasal Spray Overnight Bedtime Cold Medicine Owbridge’s Cough Mixture Oxanid Tablets 10 mg Oxanid Tablets 15 mg Oxanid Tablets 30 mg Oxy 5 Acne Lotion Oxy 10 Acne Lotion Oxy Clean Facial Wash Gel Oxy Clean Medicated Cleanser Oxymetazoline Hydrochloride Nasal Drops 0.025% Oxymetazoline Hydrochloride Nasal Drops 0.05%

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Oxymetazoline Hydrochloride Nasal Spray 0.05% Oxysept 1 Disinfecting Solution Oxysept 2 Rinsing, Neutralising and Storing Solution Ozium 500 Air Sanitizer Ozium 1500 Air Sanitizer Ozium 3000 Ozium Air Sanitizer Pacidal Tablets Pacifene Tablets Paedo-Sed Syrup Pain Relief Tablets (Cox) Pain Relief Tablets (Davidson) Paldesic Elixir Pameton Tablets Panacron Nasal Spray Panacron Tablets Panadeine Co Tablets Panadeine Forte Panadeine Soluble Effervescent Tablets Panadeine Tablets Panadol Baby & Infant Suspension Panadol Caplets Panadol Extra Soluble Tablets Panadol Extra Tablets Panadol Junior Sachets Panadol Soluble Tablets Panadol Tablets Panaleve Junior Panaleve Six Plus Suspension Panasorb Tablets Panax 600 Ginseng Tablets Panerel Tablets Panets Tablets Pango Pain Paracetamol Codeine Tablets (Cupal) Pantene Hair Tonic Papain Compound Tablets Paprika Tablets (Kerbina) Para-Seltzer Effervescent Tablets Paracetamol & Caffeine Capsules Paracetamol & Caffeine Tablets Paracetamol DC Tablets Paracetamol Tablets Soluble (Boots) Paracetamol Tablets, Sorbitol Basis 500 mg Paracets Tablets 500 mg Paraclear Tablets Paracodol Capsules Paracodol Tablets Paradeine R Tablets Paragesic Effervescent Tablets Parahypon Tablets Parake Tablets c SD No. 2005/0727 Page 87

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Paralgin Tablets Paramin Capsules Paramol Tablets Paranorm Cough Syrup Pardale Tablets Parenamps Intramuscular Injection Pastilaids Pastilles Pavacol Cough Syrup Paxadon Tablets Paxalgesic Tablets Paxidal Tablets Paynocil Tablets PEM Linctus Penetrol Inhalant Pentazocine-Aspirin Compound Tablets Peplax Peppermint Flavoured Laxative Tablets Peppermint Indigestion Tablets (Boots) Pepto-Bismol Suspension Perform 1 Disinfecting Solution Perform 2 Rinsing and Neutralising Solution Pernivit Tablets Perrier Mineral Water Persomnia Tablets Pestroy Flea and Insect Powder Petrolagar Emulsion Plain Petrolagar Emulsion with Phenolphthalein PF Plus Tablets Pharmacin Capsules Pharmacin Effervescent Plus C Tablets Pharmacin Effervescent Tablets 325 mg Pharmaton Capsules Pharmidone Tablets Phenergan Compound Expectorant Linctus Phenolphthalein Compound Pills BPC Phenolphthalein Compound Tablets BPC 1963 Phenolphthalein Tablets BP Phensedyl Cough Linctus Phensic Tablets Phensic 2 Tablets Phenylephrine Hydrochloride Nasal Drops 0.25% Phenylephrine Hydrochloride Nasal Spray 0.5% Phillips Brewers Yeast Tablets Phillips Iron Tonic Tablets Phillips Tonic Yeast Tablets Phillips’ Toothpaste Phisoderm Phisohex System Medicated Face Wash pHiso-Med Solution Pholcolix Syrup Pholcomed D Linctus Pholcomed Diabetic Forte Linctus

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Pholcomed Expectorant Pholcomed Forte Linctus Pholcomed Linctus Pholcomed Pastilles Pholtex Syrup Pholtussa Mixture Phor Pain Phor Pain Double Strength Phosferine Liquid Phosferine Multi-Vitamin Liquid Phosferine Tablets Phygeine Liquid Phyllosan Tablets Physeptone Linctus Pickles Nail Bite Lotion PIL Food Capsules Pile Mixture (Ayrton Saunders) Pile Tablets (Ayrton Saunders) Pine Bath Milk Pine Catarrh Drops Lozenges Piriton Allergy Piz Buin After Sun Lotion Piz Buin After Sun Shower Gel Piz Buin Children’s Balm SPF 8 Piz Buin Cream Factor 12 Piz Buin Creme factor 6 Piz Buin Creme factor 8 Piz Buin Factor 4 Cold Air Protection Cream Piz Buin Glacier Cream SPF 15 Piz Buin Lip Protection Stick SPF 8 Piz Buin SPF 6 Lotion Piz Buin SPF 8 Lotion Piz Buin Sun Allergy Lotion SPF 12 Piz Buin Sun Protection Lotion SPF 12 Plax Anti-Plaque Pre-Brushing Rinse Plenamin Super Plenivite with Iron Tablets Pliagel Soft Lens Solution Plurivite M Tablets Plurivite Tablets Poli-grip Denture Fixative Cream Pollon-Eze Tablets Polyalk Gel Polyalk Tablets Polyvite Capsules Porosis D Calcium Supplement Tablets Potaba + 6 Capsules Potaba + 6 Tablets Potassium Bromide & Nux Vomica Mixture BPC 1963 Potters Household Liniment Potters Nine Rubbing Oils c SD No. 2005/0727 Page 89

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Powdered Bran Tablets 2 g Power Cranberry Juice Capsules Power Cranberry Juice Concentrated Powder Power Dolomite Tablets Power Dophilus Capsules Power Feverfew Capsules Power Halibut Liver Oil Capsules Power Kelp Tablets 500 mg Power Nature Vitamin E Cream Power Nutrimental 24 Tablets Power Plus Super Multivitamin and Mineral Capsules Powerin Tablets PP Tablets PR Freeze Spray PR Heat Spray PR Tablets Prazepam Tablets 10 mg PRD 200 Tablets 600 mg Preflex Solution Pregaine Shampoo Pregnacare Capsules Pregnadon Tablets Pregnavite Forte Tablets Pregnavite Forte F Tablets Prematil with Milupan Premence-28 Capsules Premit Tablets 20 mg Prenatal Dri-Kaps Capsules Prenatol Anti Stretch Mark Cream Pre-Nutrison Primes Premiums Tablets Prioderm Cream Shampoo Priory Cleansing Herbs Powder Probase 3 Cream Pro-Bifidus Powder (Dairy Free) Procol Capsules Proctofibre Tablets Prodexin Tablets Pro-Dophilus Powder (Dairy Free) Proflex Capsules Proflex Tablets 200 mg Progress Powder Propain Tablets Propecia Pro-Plus He-Vite Elixir Proteolised Liver Tablets Protexin B Powder Protexin Natural Care Powder Protexin Natural Care Tablets Pro-Vitamin A Capsules (Rodale) Pru Sen Tablet Bar

Page 90 SD No. 2005/0727 c

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Prymecare Tablets for Soft and Gas Permeable Lenses Prymeclean Cleaning Solution for Soft Lenses Prymesoak Soaking Solution for Soft Lenses Pulmo Bailly Liquid Purgoids Tablets Pyridoxine Tablets, Slow 100 mg Quest Balanced Ratio Cal-Mag Tablets Quest Beta Carotene Tablets Quest Folic Acid with Vitamin B Capsules Quest Gamma EPA Capsules 1000 mg Quest Herbal Range Feverfew Formula Capsules Quest Improved Once-A-Day Tablets Quest Kyolic 350 Tablets Quest Mega B50 Tablets Quest Mega B-100 Timed Release Tablets Quest Mega B Complex Plus 1000 mg C Tablets Quest Multi B Complex Plus 500 mg C Tablets Quest Multi C Complex Tablets Quest Non-Dairy Acidophilus Plus Capsules Quest Once-A-Day Tablets Quest Super Mega B-50 Timed Release Tablets Quest Super Mega B + C Tablets Quest Super Once-A-Day Tablets Quest Super Once-A-Day Divided Dose Tablets Quest Synergistic Boron Tablets Quest Synergistic Iron Capsules Quest Synergistic Magnesium Tablets Quest Synergistic Selenium Capsules Quest Synergistic Zinc Capsules Quest Vitamin C Tablets Quest Vitamin C Tablets Sustained Release Quest Vitamin E Capsules Quick Action Cough Cure (Brian C Spencer) Quiet Life Tablets Rabenhorst Tomato Juice Radian-B Mineral Bath Liquid Radian-B Mineral Bath Salts Radian-B Muscle Lotion Radian-B Muscle Rub Cream Ralgex Stick Rappell Head Louse Repellent Pump Spray Raspberry Tablets No B039 Rayglo Chest Rub Ointment Rayglo Laxative Tablets Reach Mouthwash Reactivan Tablets Red Catarrh Pastilles (Baldwin) Redelan Effervescent Tablets Redoxon Adult Multivitamin Tablets Redoxon C Effervescent Tablets 1g c SD No. 2005/0727 Page 91

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Redoxon C Tablets 25 mg Redoxon C Tablets 50 mg Redoxon C Tablets 200 mg Redoxon C Tablets 250 mg Redoxon C Tablets 500 mg Redoxon Children’s Multivitamin Tablets Redoxon Effervescent Tablets 1 g Regaine Regina Royal Jelly capsules Reg-U-Lett Tablets Relanium Tablets 2 mg Relanium Tablets 5 mg Relanium Tablets 10 mg Relcofen Tablets Relcol Tablets Remegel Tablets Remnos Tablets 5 mg Remnos Tablets 10 mg Rennie Tablets Rennie Gold Tablets Rennie Plus Tablets Rennie Rap-Eze Tablets Replens Vaginal Moisturiser Resolve Granules Respaton Retinova Revlon Nutrasome Shampoo Revlon ZP11 Medicated Shampoo Rheumavit Tablets Rhuaka Herbal Syrup Rhuaka Tablets Rhubarb & Soda Mixture Ammoniated BP Rhubarb Compound Mixture BPC Rhubarb Mixture Compound Paediatric BPC Ribena Riddovydrin Liquid Rinurel Linctus Rinurel Tablets Rite-Diet Egg White Replacer Rite-Diet Gluten-Free Baking Powder Rite-Diet Gluten-Free Banana Cake Rite-Diet Gluten-Free Bourbon Biscuits Rite-Diet Gluten-Free Christmas Pudding Rite-Diet Gluten-Free Coconut Cookies Rite-Diet Gluten-Free Date & Walnut Cake Rite-Diet Gluten-Free Gingernut Cookies Rite-Diet Gluten-Free Half Covered Chocolate Digestive Biscuits Rite-Diet Gluten-Free Lemon Madeira Cake Rite-Diet Gluten-Free Muesli Cookies Rite-Diet Gluten-Free Rich Fruit Cake Rite-Diet Gluten-Free Wheat-Free Mince Pies

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Rite-Diet Hot Breakfast Cereal Robaxisal Forte Tablets Roberts Aspirin & Caffeine Tablets Robinsons Baby Rice Robinsons Instant Baby Foods Baby Breakfast Robinsons Instant Baby Foods Baby Dessert Robitussin AC Liquid Robitussin Cough Soother Robitussin Cough Soother Junior Formula Robitussin Expectorant Robitussin Expectorant Plus Robitussin Liquid Robitussin Plus Liquid Robitussin Syrup RoC Amino Moisturising Cream RoC Compact Cleanser RoC Eye Make-Up Remover Lotion RoC Face Powder Loose RoC Foundation Cream RoC High Protection Sun Cream SPF 7/9 RoC Hydra and Body Cream RoC Hydra Plus RoC Intensive Hand Cream RoC Lipo Moisturising Treatment RoC Lipo Vitamin Treatment RoC Pre-Tanning Lotion RoC Soap for Delicate Skin RoC Soothing After Sun Lotion RoC Soothing Eye Gel RoC Treatment Lipstick RoC Vitamin Cream Roche Starflower Oil Capsules 500mg Roche Starflower Oil (GLA) Capsules 250mg Rock Salmon Cough Mixture Rohypnol Tablets 1 mg Roscorbic Effervescent Tablets Roscorbic Tablets 25 mg Roscorbic Tablets 50 mg Roscorbic Tablets 200 mg Roscorbic Tablets 500 mg Rose Hip C-100 Capsules Rose Hip C-200 Capsules Rose Hip Tablets (English Grains) Rose Hip Tablets (Potters) Rose Hip Tablets (Roberts) Rosemary Bath Roskens Ultracare 3 Rosmax Syrup Roter Tablets Rovigon RRC1 Cream c SD No. 2005/0727 Page 93

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Rubelix Syrup Rubraton B Elixir Ruby Tonic Tablets (Jacksons) Rum Cough Elixir Ruthmol Rutin Plus Tablets (Gerard) Safapryn Tablets Safapryn-Co Tablets Safflower Seed Oil Sainsbury’s Aspirin Tablets 300 mg Sainsbury’s Cold Powders with Blackcurrant Sainsbury’s Hot Lemon Powders Sainsbury’s Indigestion Tablets Sainsbury’s Junior Soluble Aspirin Tablets Sainsbury’s Paracetamol Tablets 500 mg Sainsbury’s Soluble Aspirin Tablets St Clement’s Fruit Juice Concentrate Salonair Spray Salzone Syrup Salzone Tablets 500 mg Sanatogen Childrens Vitamins Plus Minerals Sanatogen Cod Liver Oil Capsules Sanatogen Garlic Oil Perle One-A-Day Sanatogen Junior Vitamins Tablets Sanatogen Multivitamins & Calcium Tablets Sanatogen Multivitamins Plus Iron (Formula One) Tablets Sanatogen Multivitamins Tablets Sanatogen Nerve Tonic Powder Sanatogen Selected Multivitamins Plus Iron (Formula Two) Tablets Sanatogen Tonic Sanatogen Vitamin B6 Capsules Sanatogen Vitamin E Capsules Sancos Compound Linctus Sancos Syrup Savant Tablets Savlon Dry Skin Cream Saxin SBL Junior Cough Linctus SBL Soothing Bronchial Linctus Schar Gluten Free Sponge Cake Scholl Foot Refresher Spray Scott’s Cod Liver Oil Capsules Scott’s Emulsion Scott’s Husky Biscuits Seatone Capsules Seatone Super Strength Capsules Seaweed Vitamin A Ester BP & Vitamin D BP Capsules (Regent Laboratories) Seba-Med Cleansing Bar Seba-Med Cream Seba-Med Facial Wash

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Seba-Med Lotion Seba-MedShampoo Sebbix Shampoo Secaderm Salve Seclodin Capsules Sedazin Tablets 1 mg Sedazin Tablets 2.5 mg Seldane Tablets Selenium ACE Tablets Selora Sodium-free Salt Substitute Selsun Soft Conditioner Senlax Tablets Senna Laxative Tablets (Boots) Senna Tablets (Potters) Senokot Tablets Senotabs Tablets Senselle Natural Feminine Moisture Toothpaste Serenid D Tablets 10 mg Serenid D Tablets 15 mg Serenid Forte Capsules 30 mg Sergeant’s Dust Mite Patrol Powder Sertin Tablets Setamol Soluble Tablets Setlers Extra Strength Tablets Setlers Liquid Setlers Tablets Seven Seas Antioxidant Beta Carotene Capsules Seven Seas Antioxidant Vitamin E Capsules Seven Seas Beta Carotene Capsules Seven Seas Calcium Chewables (Chewable Caps) Seven Seas Cod Liver Oil Seven Seas Evening Primrose Oil Capsules Seven Seas Folic Acid & Vitamin B12 One-A-Day Tablets Seven Seas Formula 70 Multivitamin-Multimineral Capsules Seven Seas Garlic Oil Perles Seven Seas Iron Chewables (Chewable Caps) Seven Seas Korean Ginseng Capsules Seven Seas Lecithin Capsules Seven Seas Magnesium Berries Seven Seas Malt and Cod Liver Oil Seven Seas Multivitamin & Mineral Capsules Seven Seas Natural Vitamin E in Wheatgerm Capsules Seven Seas Orange Syrup & Cod Liver Oil Seven Seas Pulse Capsules Seven Seas Pure Cod Liver Oil Capsules Seven Seas Pure Starflower Oil Seven Seas Selenium E & Cod Liver Oil Capsules Seven Seas Start Right Cod Liver Oil for Babies Seven Seas Vitamin and Mineral Tonic Seven Seas Wheatgerm Oil Capsules c SD No. 2005/0727 Page 95

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Seven Seas Zinc Chewables (Chewable Caps) Sidros Tablets Silk-Lax Tablets Siloxyl Suspension Siloxyl Tablets Simeco Suspension Simeco Tablets Simple Hair Conditioner Simple Moisturising Lotion Simple Night Cream Simple Protective Moisture Cream Simple Refreshing Shower Gel Simple Shampoo Simple Soap Simple Sun Block Simple Talcum Powder Sine-Off Tablets Sinitol Capsules Sinutab Tablets Sionon Sweetner Skin Glow Capsules Slim-Fast Meal Replacement SMA Gold Cap Powder and Ready-to-Feed SMA Powder and Concentrated Liquid Snufflebabe Vapour Rub Soaclens Solution Soframycin Ointment Softab Soft Lens Care Tablets Solgar Cartilade Capsules Solgar Ester-C Tablets Solgar Evening Primrose Oil Solgar Glucosamine Sulfate Tablets Solgar Maxi Coenzyme Q10 Capsules Solgar Maxi L-Carnitine Tablets Solgar Provatene Softgel Capsules Solis Capsules 2 mg Solis Capsules 5 mg Solis Capsules 10 mg Solmin Tablets Capsules Solpadeine Forte Tablets Solpadeine Tablets Solpadeine Tablets Effervescent Solprin Tablets Soluble Aspirin Tablets for Children (Boots) Soluble Phensic Tablets Solusol Solution Sominex Tablets Somnite Suspension 2.5 mg/5 ml Somnite Tablets 5 mg Soquette Soaking Solution

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Sovol Liquid Sovol Tablets Soya Powder & Nicotinamide Tablets SP Cold Relief Capsules Special E Moisture Cream Special Stomach Powder (Halls) Spectraban 4 Lotion SPHP Tablets SPS Low-Protein Drink Squill Linctus Opiate BP (Gee’s Linctus) Squill Linctus Opiate, Paediatric, BP Squire’s Soonax Tablets SR2310 Expectorant SR Toothpaste (Gibbs) Staffords Mild Aperient Tablets Staffords Strong Aperient Tablets Steradent Mouthwash Steri-Clens Solution Steri-Solve Soft Lens Solution Sterling Health Salts Effervescent Sterling Indigestion Tablets Sterling Paracetamol Tablets Sterogyl Alcoholic Solution Stomach Aids Tablets Stomach Mixture (Herbal Laboratories) Stomach Mixture H138 (Southon Laboratories) Stomach Powder (Diopharm) Stomach Tablets (Ulter) Stop ‘N’ Grow Nail Biting Deterrent Street’s Cough Mixture Strengthening Mixture (Hall’s) Stress B Supplement Tablets Strychnine & Iron Mixture BPC 1963 Strychnine Mixture BPC 1963 Stute Diabetic Blackcurrant Jam Stute Diabetic Marmalade Sudafed Co Tablets Sudafed Expectorant Sudafed Linctus Sudafed Nasal Spray Sudocrem Baby Lotion Suleo C Shampoo Sun E45 Lotion SPF8 Sunerven Tablets Sunnyvale Gluten-Free Rich Plum Pudding Sun Yums Gluten Free & Dairy Free Almond & Coconut Cake Sun Yums Gluten Free & Dairy Free Banana & Sesame Seed Cake Sun Yums Gluten Free & Dairy Free Carob & Mint Cake Sun Yums Gluten Free & Dairy Free Ginger & Pecan Nut Cake Sun Yums Gluten Free & Dairy Free Jaffa Spice Cake Super Plenamins Tablets c SD No. 2005/0727 Page 97

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Super Yeast + C Tablets Superdophilus Powder Superdrug Health Salts Superdrug Heat Spray Supradyn Capsules Supradyn Effervescent Tablets Supradyn Tablets for Children Surbex-T Tablets Surem Capsules 5 mg Surem Capsules 10 mg Surelax Laxative Tablets Sweetex Sylopal Suspension Sylphen Tablets Syn-Ergel Syndol Tablets Syrtussar Cough Syrup T-Zone Decongestant Tablets Tabasan Tablets Tablets No B006 Tablets No B011 Tablets No B015 Tablets No B024 Tablets No B025 Tablets No B029 Tablets No B034 Tablets No B035 Tablets No B036 Tablets No B037 Tablets No B038 Tablets No B040 Tablets No B041 Tablets No B045 Tablets No B048 Tablets No B070 Tablets No 268A (Potters) Tablets to Formula A10 Tablets to Formula A11 Tablets to Formula A18 Tablets to Formula A19 Tablets to Formula A20 Tablets to Formula A22 Tablets to Formula A23 Tablets to Formula A31 Tablets to Formula A32 Tablets to Formula A33 Tablets to Formula A45 Tablets to Formula A51 Tablets to Formula A63 Tablets to Formula A67 Tablets to Formula A68

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Tablets to Formula A69 Tablets to Formula A70 Tablets to Formula A71 Tablets to Formula A105 Tablets to Formula A111 Tablets to Formula A114 Tablets to Formula A120 Tablets to Formula A147 Tablets to Formula A157 Tablets to Formula A158 Tablets to Formula A161 Tablets to Formula A162 Tablets to Formula A164 Tablets to Formula A165 Tablets to Formula A166 Tablets to Formula A167 Tablets to Formula A169 Tablets to Formula A175 Tablets to Formula A183 Tablets to Formula A184 Tablets to Formula A190 Tablets to Formula A195 Tablets to Formula A202 Tablets to Formula A203 Tablets to Formula A213 Tablets to Formula A221 Tablets to Formula A244 Tablets to Formula A245 Tablets to Formula A246 Tablets to Formula A247 Tablets to Formula A248 Tablets to Formula A249 Tablets to Formula A250 Tablets to Formula A264 Tablets to Formula A266 Tablets to Formula A270 Tablets to Formula A271 Tablets to Formula A272 Tablets to Formula A273 Tablets to Formula A274 Tablets to Formula A275 Tablets to Formula A276 Tablets to Formula A277 Tablets to Formula A298 Tablets to Formula A301 Tablets to Formula A316 Tablets to Formula BA6 Tablets to Formula B10 Tablets to Formula B15 Tablets to Formula B18 Tablets to Formula B19 c SD No. 2005/0727 Page 99

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Tablets to Formula B20 Tablets to Formula B21 Tablets to Formula B22 Tablets to Formula B25 Tablets to Formula B26 Tablets to Formula B29 Tablets to Formula B41 Tablets to Formula B48 Tablets to Formula B51 Tablets to Formula B56 Tablets to Formula B58 Tablets to Formula B64 Tablets to Formula B65 Tablets to Formula B66 Tablets to Formula B67 Tablets to Formula B68 Tablets to Formula B70 Tablets to Formula B71 Tablets to Formula B72 Tablets to Formula B73 Tablets to Formula B74 Tablets to Formula B75 Tablets to Formula B76 Tablets to Formula B77 Tablets to Formula B78 Tablets to Formula B79 Tablets to Formula B80 Tablets to Formula B81 Tablets to Formula B82 Tablets to Formula B83 Tablets to Formula B85 Tablets to Formula B86 Tablets to Formula B87 Tablets to Formula B90 Tablets to Formula B91 Tablets to Formula B93 Tablets to Formula B94 Tablets to Formula B96 Tablets to Formula B98 Tablets to Formula B100 Tablets to Formula B102 Tablets to Formula B104 Tablets to Formula B117 Tablets to Formula B118 Tablets to Formula B120 Tablets to Formula B122 Tablets to Formula B124 Tablets to Formula B128 Tablets to Formula B141 Tablets to Formula B143 Tablets to Formula B145

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Tablets to Formula B148 Tablets to Formula B156 Tablets to Formula B157 Tablets to Formula B158 Tablets to Formula B160 Tablets to Formula B163 Tablets to Formula B169 Tablets to Formula B178 Tablets to Formula B180 Tablets to Formula B181 Tablets to Formula B182 Tablets to Formula B190 Tablets to Formula B193 Tablets to Formula B207 Tablets to Formula B209 Tablets to Formula B210 Tablets to Formula B211 Tablets to Formula B212 Tablets to Formula B213 Tablets to Formula B214 Tablets to Formula B215 Tablets to Formula B216 Tablets to Formula B217 Tablets to Formula B218 Tablets to Formula B222 Tablets to Formula B223 Tablets to Formula B224 Tablets to Formula B225 Tablets to Formula B227 Tablets to Formula B228 Tablets to Formula B231 Tablets to Formula B234 Tablets to Formula B235 Tablets to Formula B236 Tablets to Formula B243 Tablets to Formula B248 Tablets to Formula B250 Tablets to Formula B251 Tablets to Formula B252 Tabmint Anti-Smoking Chewing Gum Tablets Tanacet Feverfew 125 Tancolin Childrens Cough Linctus Tedral Expectorant T-Gel Conditioner Temazepam Gelthix Capsules Temazepam Planpak Temazepam Soft Gelatin Gel-Filled Capsules Tenaset Wash Cream Tenaset Wash Cream (Unperfumed) Tensium Tablets 2 mg Tensium Tablets 5 mg c SD No. 2005/0727 Page 101

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Tensium Tablets 10 mg Tercoda Elixir Tercolix Elixir Terpalin Elixir Terperoin Elixir Terpoin Antitussive Terrabron Thermogene Medicated Rub Thixo-D Thickened Drink Mixes Three Noughts Cough Syrup Tidmans Bath Sea Salt Tidman’s Sea Salt Coarse Tiger Balm Liquid Tiger Balm White Tiger Balm Red Timotei Herbal Shampoo Tinaderm Cream Titan Hard Cleanser Tixylix Cough and Cold Linctus Tixylix Cough Linctus Tixylix Day-Time Cough Linctus Tixylix Decongestant Inhalant Capsules Tolu Compound Linctus Paediatric BP Tolu Solution BP Tolu Syrup BP Tonatexa Mixture Tonic Tablets (Thomas Guest) Tonic Wines Tonivitan A & D Syrup Tonivitan B Syrup Tonivitan Capsules Top C Tablets Topfit Amino Acid Powder Topfit L-Threonine + Vitamin B6 Capsules 500/12.5mg Toptabs Total All Purpose Solution Total Nutrient Liquid Totavit D R Capsules Totolin Paediatric Cough Syrup Tramil Capsules Trancoprin Tablets Transclean Cleaning Solution Transdrop Transoak Solution Transol Solution Tranxene Capsules 7.5 mg Tranxene Capsules 15 mg Tranxene Tablets 15 mg Triludan Forte Tablets 7-tablet pack Triludan Tablets 10-tablet pack Triocos Linctus

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Triogesic Elixir Triogesic Tablets Triominic Syrup Triominic Tablets Triopaed Linctus Triotussic Suspension Triovit Tablets Triple Action Cold Relief Tablets Tropium Capsules 5 mg Tropium Capsules 10 mg Tropium Tablets 5 mg Tropium Tablets 10 mg Tropium Tablets 25 mg Trufree Crispbran Trufree Tandem IQ Tablets Trufree Vitamin & Minerals Tablets Tudor Rose Bay Rhum Tablets Tusana Linctus Tussifans Syrup Tussimed Liquid Two-A-Day Iron Jelloids Tablets Tymasil Tysons Catarrh Syrup Ucerax Tablets Udenum Gastric Vitamin Powder Ultracach Analgesic Capsules Ultradal Antacid Stomach Tablets Ultralief Tablets Uncoated Tablets to Formula A323 Uncoated Tablets to Formula A325 Undecyn Capsules Unguentum Merck Cream 60g Unicap M Tablets Unicap T Tablets Unichem Baby Oil Unichem Chesty Cough Linctus Unichem Children’s Dry Cough Linctus Unichem Cod Liver Oil Capsules Unichem Cold Relief Capsules Unichem Cold Relief Day-Time Liquid Unichem Cold Relief Night-Time Liquid Unichem Cold Relief Powders Unichem Dry Cough Linctus Unichem Extract of Malt with Cod Liver Oil Unichem Multivitamins + Iron Tablets Unichem Multivitamins & Minerals One-A-Day Capsules Uniflu Tablets Unigesic Capsules Unigest Tablets Unisomnia Tablets 5 mg c SD No. 2005/0727 Page 103

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

United Skin Care Programme (Uni Derm; Uni-Salve; Uni-Wash) Uvistat Aftersun Lotion Uvistat Baby Sun Cream SPF 12 Uvistat Cream SPF 4 Uvistat Facial Cream SPF 8 Uvistat Facial Cream SPF 22 Uvistat Lipscreen SPF 5 Lipstick Uvistat SPF 8 Suncream Uvistat SPF 10 Suncream Uvistat Sun Lotion SPF 6 Uvistat Sun Lotion SPF 8 Vadarex Wintergreen Heat Rub Vagisil Feminine Powder Valium Capsules 2 mg Valium Capsules 5 mg Valium Syrup 2 mg/5 ml Valium Tablets 2 mg Valium Tablets 5 mg Valium Tablets 10 mg Valonorm Tonic Solution Valrelease Capsules Vanamil Tablets Vantage Baby Shampoo Vantage Garlic One-A-Day Capsules Vantage Halibut Fish Oil One-A-Day Capsules Vantage Sterilising Fluid Vapex Inhalant Vaseline Intensive Care Lotion Vaseline Intensive Care Lotion Herbal and Aloe Vega Glucosamine Sulphate Capsules Veganin Tablets Veno’s Adult Formula Cough Mixture Veno’s Cough Mixture Veno’s Honey & Lemon Cough Mixture Veracolate Tablets Verdiviton Elixir Vervain Compound Tablets Vichy Total Sunscreen Vicks Coldcare Capsules Vicks Cremacoat Syrup Vicks Cremacoat Syrup with Doxylamine Succinate Vicks Cremacoat Syrup with Guaiphenesin Vicks Cremacoat Syrup with Paracetamol & Dextromethorphan Vicks Daymed Vicks Formula 44 Cough Mixture Vicks Inhaler Vicks Medinite Vicks Pectorex Solution Vicks Sinex Nasal Spray Vicks Vapo-Lem Powder Sachets Vicks Vaposyrup Childrens Dry Cough

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Vicks Vaposyrup for Chesty Coughs Vicks Vaposyrup for Chesty Coughs and Nasal Congestion Vicks Vaposyrup for Dry Coughs Vicks Vaposyrup for Dry Coughs and Nasal Congestion Vicks Vapour Rub Vi-Daylin Syrup Videnal Tablets Vigour Aids Tablets Vigranon B Complex Tablets Vigranon B Syrup Vikelp Coated Tablets Vikonon Tablets Villescon Liquid Villescon Tablets Viobin Octacosanol Tablets 50000 mcg Viobin Pancreatin Tablets 325 mg Vipro Vegetable Protein Virvina Elixir Vitabrit Beta Carotene Capsules Vita Diem Multi Vitamin Drops Vita-E 200 (D-Alpha Tocopherol) Capsules Vita-E Cream Vita-E Ointment Vital Dophilus Powder Vitalia Calcium Formula A + D Tablets Vitalia Lecithin Capsules High Potency Vitalia Multivitamins & Minerals Children’s Chewable Sugar-Free Tablets Vitalia Multivitamins & Minerals with Iron Tablets Vitalia Multivitamins & Minerals Tablets without Iron Vitalia Natural E Capsules Vitalia Vitamin A Tablets Vitalia Vitamin B Complex Super Tablets Vitalia Vitamin B6 Tablets Vitalia Vitamin C Chewable Tablets Vitalia Vitamin E Tablets Vitalia Zinc Amino Acid Chelated Tablets 15 mg Vitalia Zinc Chelated Tablets Vitalife Vital E Capsules Vitalife Vitamin B6 Capsules Vitalife Vitamin B Complex Tablets Vitalin Tablets Vitalzymes Capsules Vitamin & Iron Tonic (Epitone) Solution Vitamin A & D Capsules BPC 1968 (Regent Laboratories) Vitamin A Ester and Vitamin D2 Capsules (Regent Laboratories) Vitamin A Ester Capsules (Regent Laboratories) Vitamin A Ester Conc, Alpha Tocopheral Acetate Nat Capsules (Regent Laboratories) Vitamin A 4500 Units & Vitamin D2 Capsules (Regent Laboratories) Vitamin A 6000 Units & Vitamin D2 Capsules (Regent Laboratories) c SD No. 2005/0727 Page 105

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 3 2005

Vitamin A, C & D Tablets (Approved Prescription Services) Vitamin A, D & C Tablets (Regent Laboratories) Vitamin B Complex Tablets (English Grains) Vitamin B Complex with Brewer’s Yeast Tablets (English Grains) Vitamin B1 Dried Yeast Powder (Distillers) Vitamin B1 Yeast Tablets (Distillers) Vitamin B12 Tablets 0.01 mg Vitamin B12 Tablets 0.025 mg Vitamin B12 Tablets 0.05 mg Vitamin B12 Tablets 0.10 mg Vitamin B12 Tablets 0.25 mg Vitamin B12 Tablets 0.5 mg Vitamin B12 Tablets 1 mg Vitamin C Tablets Effervescent 1 g Vitamin C Tablets (G & G Food Supplies) Vitamin Capsules (Regent Laboratories) Vitamin Malt Extract with Orange Juice (Distillers) Vitamin Mineral Capsules (Regent Laboratories) Vitamin Tablets No B077 Vitamin Tablets No B081 Vitamin Tablets No B084 Vitaminised Iron & Yeast Tablets (Kirby Warrick Pharmaceuticals) Vita Natura Evening Primrose Oil + Vitamin E Tablets Vitanorm Malt Extract Vitanorm Malt Extract Syrup Vitapointe Conditioner Vitasafe’s CF Kaps Tablets Vitasafe’s WCF Kaps Tablets Vita-Six Capsules Vitathone Chilblain Tablets Vitatrop Tablets Vitavel Powder for Syrup Vitavel Solution Vitepron Tablets Vitorange Tablets Vitrite Multi-Vitamin Syrup Vykmin Fortified Capsules W L Tablets Wallachol Syrup Wallachol Tablets Wate-on Emulsion Wate-on Emulsion Super Wate-on Tablets Wate-on Tablets Super Wate-on Tonic Waterhouses All Fours Wines Woodwards Nursery Cream Wrights Glucose with Vitamin D Powder Wrights Vaporizing Fluid Xanax Tablets 0.25 mg

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Xanax Tablets 0.5 mg Xanax Tablets 1.0 mg Yeast & B12 Tablets (English Grains) Yeast Plus Tablets (Thomas Guest) Yeast-Vite Tablets Yellow Phenolphthalein Tablets (any strength) Yestamin Vitamin B5 Tablets Zactirin Tablets Zam Buk Ointment Zefringe Sachets Zemaphyte Chinese Herbal Eczema Remedy Zendium Toothpaste Zenoxone Cream Zirtek 7 Zubes Expectorant Cough Syrup Zubes Original Cough Mixture Zyriton Expectorant Linctus

c SD No. 2005/0727 Page 107

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 4 2005

SCHEDULE 443

[Regulation 15A]

DRUGS OR MEDICINES TO BE ORDERED ONLY IN CERTAIN CIRCUMSTANCES

Drugs Patient Condition Clobazam Any patient Treatment of epilepsy

Cyanocobalamin A patient who is a vegan or who has a Treatment or prevention of Tablets proven vitamin B12 deficiency of vitamin B12 deficiency dietary origin

Locabiotal Aerosol Any patient Treatment of infections and inflammation of the oropharynx

Niferex Elixir 30ml Infants born prematurely Prophylaxis and treatment Paediatric Dropper of iron deficiency Bottle

Nizoral Cream Any patient Treatment of seborrhoeic dermatitis and pityriasis versilocor

Oseltamivir (1) A patient who is at clinical risk or a Treatment of influenza (Tamiflu) patient who is pregnant or aged 65 years or over, or who is aged under 65 years and is at risk of developing medical complications for influenza, where— (a) the Department has notified general medical practitioners that the influenza virus is circulating in the community; (b) the patient has an influenza-like illness; and (c) the patient can start therapy within 48 hours of the onset of symptoms. (1A) Any patient suffering from influenza during an outbreak of pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under arrangements for the distribution of the drug free of charge which are approved by the Department.

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National Health Service (Pharmaceutical Services) Regulations 2005 SCHEDULE 4

(2) A patient who is at clinical risk or a patient who is pregnant or aged 65 years or over, or who is aged under 65 years and is at risk of developing medical complications for influenza, where— (a) it has been determined in accordance with a community based virological surveillance scheme that influenza A or influenza B is circulating in the locality in which the patient resides or is present or was present at the time that the virus was circulating; (b) the patient has an influenza-like illness; and (c) the patient can start therapy within 48 hours of the onset of symptoms.

(3) A patient who is aged 1 year or over Prophylaxis of influenza and who is at clinical risk or a patient who is pregnant or aged 65 years or over, where— (a) the Department has notified general medical practitioners that the influenza virus is circulating in the community; (b) the patient has been exposed to an influenza-like illness through being in close contact with someone with whom he or she lives who is or has been suffering from an influenza-like illness; (c) the patient is not effectively protected by vaccination against influenza because— (i) he or she has not been vaccinated because vaccination is contraindicated; (ii) he or she has not been vaccinated since the previous influenza season; (iii) he or she has been vaccinated but it has yet to take effect; or (iv) he or she has been vaccinated but the vaccine is not well matched to the strain of influenza circulating in the locality in which the patient resides or is or has been present; (d) the patient lives in an adult care home and another resident or member of staff of the establishment has an influenza-like illness; and (e) the patient can start prophylaxis within 48 hours of exposure to an c SD No. 2005/0727 Page 109

National Health Service (Pharmaceutical Services) Regulations SCHEDULE 4 2005

influenza-like illness. (4) A patient who is aged 1 year or over and who is at clinical risk or a patient who is pregnant or aged 65 years or over, where— (a) it has been determined in accordance with a community based virological surveillance scheme that influenza A or influenza B is circulating in the locality in which the patient resides or is present or was present at the time that the virus was circulating; (b) the patient has been exposed to an influenza-like illness through being in close contact with someone with whom he or she lives who is or has been suffering from an influenza-like illness; (c) the patient is not effectively protected by vaccination against influenza because— (i) he or she has not been vaccinated because vaccination is contraindicated; (ii) he or she has not been vaccinated since the previous influenza season; (iii) he or she has been vaccinated but it has yet to take effect; or (iv) he or she has been vaccinated but the vaccine is not well matched to the strain of influenza circulating in the locality in which the patient resides or is or has been present; (d) the patient lives in an adult care home residential care establishment and another resident or member of staff of the establishment has an influenza-like illness; and (e) the patient can start prophylaxis within 48 hours of exposure to an influenza-like illness. (5) Any patient at risk from influenza during an outbreak of pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under arrangements for the distribution of the drug free of charge which are approved by the Department.

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Zanamivir (Relenza) (1) A patient who is aged 5 years or Treatment of influenza over and who is at clinical risk or a patient who is pregnant or aged 65 years or over, or who is aged under 65 years and is at risk of developing medical complications from influenza, where— (a) the Department has notified general medical practitioners that the influenza virus is circulating in the community; (b) the patient has an influenza-like illness; and (c) in the case of a patient— (i) who has attained the age of 5 years but not the age of 13 years, that patient can start therapy within 36 hours of the onset of symptoms; (ii) who is aged 13 years or over, that patient can start therapy within 48 hours of the onset of symptoms. (2) A patient who is aged 5 years or over and who is at clinical risk or a patient who is pregnant or aged 65 years or over, or who is aged under 65 years and is at risk of developing medical complications from influenza where— (a) it has been determined in accordance with a community based virological surveillance scheme that influenza A or influenza B is circulating in the locality in which the patient resides or was present at the time that the virus was circulating; (b) the patient has an influenza-like illness; and) (c) in the case of a patient— (i) who has attained the age of 5 years but not the age of 13 years, that patient can start therapy within 36 hours of the onset of symptoms; (ii) who is aged 13 years or over, that patient can start therapy within 48 hours of the onset of symptoms. Any patient at risk of or suffering from Prophylaxis or treatment of influenza during an outbreak of influenza pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under c SD No. 2005/0727 Page 111

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arrangements for the distribution of the drug free of charge which are approved by the Department. The following drugs (1) The following patients with erectile Treatment of erectile for the treatment of dysfunction— dysfunction erectile (a) a man with erectile dysfunction dysfunction– who on 14th September 1998 was Alprostadil receiving a course of treatment under the Act, the National Health Service (Scotland) Act 1978 or the Health and Avanafil Personal Social Services (Northern Ireland) Order 1972 for this condition Sildenafil with any of the following drugs — Alprostadil (Caverject), (MUSE), Tadalafil (Viridal) Apomorphine Hydrochloride (Uprima) Moxisylyte Hydrochloride Assembly (Erecnos) Sildenafil (Viagra) Tadalafil (Cialis) Thymoxamine Hydrochloride (Erecnos); or

(c) a man who is suffering from any of the following — diabetes multiple sclerosis Parkinson’s disease poliomyelitis prostate cancer severe pelvic injury single gene neurological disease spina bifida spinal cord injury; or (d) a man who is receiving treatment for renal failure by dialysis; or (e) a man who has had the following surgery — prostatectomy radical pelvic surgery renal failure treated by transplant (2) Any patient Treatment of a condition other than erectile dysfunction, in respect of which the drug ordered is in receipt of a UK or EU marketing authorisation for the treatment of that condition

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In this Schedule — “adult care home” has the same meaning as in section 16 of the Regulation of Care Act 2013; “at risk” means in relation to a patient, a patient who— (a) has chronic respiratory disease (including asthma and chronic obstructive pulmonary disease); (b) has significant cardiovascular disease, excluding a patient who has hypertension only; (c) has chronic renal disease; (d) is immunocompromised; (e) has diabetes mellitus; (f) has chronic liver disease; or (g) has chronic neurological disease; and “pandemic influenza” means influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza.

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National Health Service (Pharmaceutical Services) Regulations Endnotes 2005

ENDNOTES

Table of Endnote References

1 The format of this legislation has been changed as provided for under section 75 of, and paragraph 2 of Schedule 1 to, the Legislation Act 2015. The changes have been approved by the Attorney General after consultation with the Clerk of Tynwald as required by section 76 of the Legislation Act 2015. 2 Definition of “appropriate non-proprietary name” substituted by SD2019/0148. 3 Definition of “British Approved Name” inserted by SD2019/0148. 4 Definition of “British Approved Modified Name” inserted by SD2019/0148. 5 Definition of “doctor” substituted by SD2019/0148. 6 Definition of “ETP service” inserted by SD2019/0148. 7 Definition of “EU marketing authorisation” inserted by SD2019/0416. 8 Definition of “General Medical Council” inserted by SD2019/0148. 9 Definition of “General Pharmaceutical Council register” inserted by SD2019/0148. 10 Definition of “International Nonproprietary Name” inserted by SD2019/0148. 11 Definition of “International Nonproprietary Name Modified” inserted by SD2019/0148. 12 Definition of “medicinal product” inserted by SD2019/0416. 13 Definition of “Misuse of Drugs Regulations” substituted by sD2019/0148. 14 Definition of “non-proprietary name” substituted by SD2019/0148. 15 Definition of “Nursing and Midwifery Register” amended by SD2019/0148. 16 Definition of “prescription only medicine” inserted by SD2019/0416. 17 Definition of “the Prescription of Drugs Regulations” revoked by SD2019/0148. 18 Definition of “professional registration number” revoked by SD2019/0148. 19 Definition of “relevant register” revoked by SD2019/0148. 20 Definition of “Scheduled drug” substituted by SD2019/0148. 21 Definition of “serious shortage protocol” inserted by SD2019/0416. 22 Definition of “SSP” inserted by SD2019/0416. 23 Definition of “UK marketing authorisation” inserted by SD2019/0416. 24 Reg 2 amended by SD2019/0148. 25 Reg 14 substituted by SD2019/0148. 26 Reg 15A inserted by SD2019/0148. 27 Reference substituted by SD2019/0148. 28 Para 1 substituted by SD2019/0148. 29 Para 4 amended by SD2019/0148. 30 Para (ii) amended by SD2019/0148. 31 Para (ii) amended by SD2019/0148. 32 Cross-heading inserted by SD2019/0416. 33 Para 5A inserted by SD2019/0416. 34 Subpara (3) amended by SD2019/0416.

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35 Subpara (4) amended by SD2019/0416. 36 Subpara (14) inserted by SD2019/0416. 37 Subpara (2A) inserted by SD2019/0416. 38 Subpara (2B) inserted by SD2019/0416. 39 Entry amended by SD2019/0148. 40 Entry amended by SD2019/0148. 41 Subpara (f) amended by SD2019/0148. 42 Sch 3 inserted by SD2019/0148. 43 Sch 4 inserted by SD2019/0148.

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