Consultation Letter: Mlx 291

( 020 7273 0494 020 7273 0293

Date: 26 November 2002 To: Interested Organisations

CONSULTATION LETTER: MLX 291 CHILD RESISTANT PACKAGING: PROPOSAL TO INTRODUCE REGULATIONS TO IMPLEMENT A NEW STANDARD ON CHILD RESISTANT PACKAGING.

INTRODUCTION I am writing to consult you on a proposal to introduce new Regulations relating to paracetamol, aspirin and iron supplements in order to take account of the British Standard on Child Resistant Packaging for non reclosable packaging for pharmaceuticals – BS 8404. The new Regulations will apply across the United Kingdom. Medicines containing more than 24mg of elemental iron per unit dose as well as liquid paracetamol preparations will also, for the first time, have to meet the current requirements applying to reclosable containers of solid dosage forms of aspirin and paracetamol.

Rationale

The new Regulation has been designed to require Marketing Authorisation (MA) Holders (MAH’s) for products containing aspirin, liquid/solid paracetamol and iron (>24mg per unit dose) to comply with BSEN28317 (reclosable packs) and BS8404 (non reclosable packs), with limited exceptions. BS8404 introduces a new standard for blister packs. We propose to make the standard mandatory for new applications for MAs and propose a transitional period of twelve months so that any relevant changes to existing MAs can be made. Products already on the market at that date, which are still in shelf life, will be able to stay on the market until their shelf life expires.

The new Regulations will continue to allow patients to receive these medicines in a container which is not child resistant, if they wish to do so, if they make a specific request to a pharmacist or their doctor to that effect.

BACKGROUND The Medicines (Child Safety) Regulations 1975 (as amended) require medicines containing solid oral dosage forms of aspirin and paracetamol to be packaged in containers which are resistant to opening by children. Reclosable containers must

MCA/PL/MLX291 1 be packaged in containers which are resistant to opening by children. Reclosable containers generally comply with BSEN28317, and non-reclosable containers, such as strip or blister packaging, must be chosen with a view to their resistance to opening by children. These regulations also require the pack sizes of medicines that are intended for administration exclusively to children not to exceed 25 dosage units.

Although the British Standard for reclosable containers for pharmaceuticals has been in existence for many years, there has been no similar standard for blister or strip packs. In 1989 the British Standards Institute, in conjunction with the pharmaceutical industry, produced a Code of Practice for non- reclosable packaging for solid dosage units of medicinal products (BS7236). The Code aimed to form a practical basis for the development of packaging with acceptable child resistant features but this is not legally binding. Although the existing regulation talks about “ containers selected with a view to their resistance to opening by children” there has been no specific standard linked to this requirement.

Increasing use of blister packs and the move away from dispensing from bulk, mean more medicines are reaching the patient without the safeguard of the requirement to meet an enforceable standard, including the requirement for testing by children.

Within Europe, the Comite European De Normalisation (CEN) is developing a standard to cover the testing of blister packs for pharmaceuticals for child resistance and work on this is still progressing.

Because of the absence of a European standard, BSI have put in place a national standard (BS8404) for child resistant packaging of medicines, which is based on the current draft of CEN standard, by which it may eventually be replaced. We propose to incorporate this standard into UK law by introducing a new Regulation in advance of the CEN standard.

In addition, the Committee on Safety of Medicines has advised that the requirement for child resistant packaging should be extended to include medicines containing in excess of 24mg of elemental iron per unit dose and liquid paracetamol preparations.

The Medicines (Child Safety) Regulations 1975 (as amended) require the pack sizes of medicines in non reclosable and reclosable containers, that are intended for administration exclusively to children, not to exceed 25 dosage units. We are proposing to keep this restriction in the new Regulations but would welcome views on this proposal.

In updating and consolidating the Regulations we are also taking the opportunity to remove reference to BS 6652.

A copy of the draft Statutory Instrument taking in the relevant changes is attached at A.

COMMENTS You are invited to comment on these proposals and a form is attached for your reply. You are also invited to comment on the possible impact on business of the

MCA/PL/MLX291 2 proposed changes and draft Regulatory Impact Assessment, which is attached at B. Copies of the final version would be made available to Ministers, Parliament and to the public. It would therefore be helpful if you could identify and quantify any direct or indirect costs (recurring or non-recurring) or any profits which would be likely to arise for business in your sector if these changes are made.

Comments should be addressed to Amanda Lawrence, in room 14-152 at the above address, to arrive by 18 February 2003. Contributions received after that date cannot be included in the exercise.

MAKING COPIES OF REPLIES AVAILABLE TO THE PUBLIC To help informed debate on the issues raised by this consultation exercise, and within the terms of the Code of Practice on Access to Government Information ("Open Government"), the Agency intends to make copies of replies received publicly available. Copies will be available shortly after the public consultation has ended.

The Agency's Information Centre at Market Towers will supply copies upon request. Copies may be further reproduced. An administrative charge, to cover the cost of photocopying and postage, may be applied. Alternatively, personal callers can inspect the replies at the Information Centre by prior appointment. To make an appointment, telephone 020 7273 0351.

It will be assumed that your reply can be made publicly available in this way unless you indicate that you wish all, or part of it, to be treated as confidential and excluded from this arrangement. Under the Code of Practice on Access to Government Information, the Agency will not release confidential replies or replies containing personal confidential information.

THE REVIEW PROCESS As part of this consultation process, MA holders for products already on the market who are affected by these changes will be given an opportunity to make oral representations to the Medicines Commission about the proposals, should they request an opportunity to do so before the end of December. They may also ask for any representations that they make in writing during the public consultation period specifically to be considered by Medicines Commission, who will in any event be considering a report of all the responses received during the public consultation, once it is at an end.

If a number of MA holders wish to make oral representations to the Medicines Commission, arrangements may be made for those representations to be put by a collective representative of all those wishing to make representations.

Yours faithfully,

Jeremy Mean POST-LICENSING DIVISION * 14-111 Market Towers

MCA/PL/MLX291 3 To: Amanda Lawrence Medicines Control Agency Room 14-152 Market Towers 1 Nine Elms Lane LONDON SW8 5NQ

From : ______

CONSULTATION LETTER MLX 291

CHILD RESISTANT PACKAGING: PROPOSAL TO INTRODUCE REGULATIONS TO IMPLEMENT A NEW STANDARD ON CHILD RESISTANT PACKAGING.

* 1. We have no comment to make on the proposals in MLX 291 * 2. Our comments on the proposals in MLX 291 are below/attached.

* My reply may be made freely available. * My reply is confidential. * My reply is partially confidential (indicate clearly in the text any confidential elements)

Signed : ______

* Delete as appropriate

MCA/PL/MLX291 4 Annex A Consultation draft: November 2002

STATUTORY INSTRUMENTS

2003 No.

MEDICINES

The Medicines (Child Safety) Regulations 2003

Made ------2003

Laid before Parliament 2003

Coming into force - 2003

As respects England, Scotland and Wales, the Secretary of State concerned with health in England and, as respects Northern Ireland, the Department of Health, Social Services and Public Safety, acting jointly, in exercise of the powers conferred upon them by sections 87(1), 88(1) and (2), 91(2) and 129(5) of the Medicines Act 1968(a), or, as the case may be, the powers conferred by the said provisions and now vested in them(b), and of all other powers enabling them in that behalf, after consulting, pursuant to section 129(6) of that Act, such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations, and after taking into account, pursuant to section 129(7) of that Act, a () 1968 c.67; the expression “the appropriate Ministers” in sections 87(1) and 88(1) of that Act, which is relevant to the powers being exercised in the making of these Regulations, is defined in section 1(2) of that Act. b () In the case of the Secretary of State concerned with health in England, by virtue of articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; and in the case of the Department of Health, Social Services and Public Safety, the powers vested in the Minister in charge of that Department by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47) may now be exercised by the Department by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c.1).

MCA/PL/MLX291 5 the advice of the Medicines Commission, hereby make the following Regulations: —

Citation, commencement and interpretation 1.-(1) These Regulations may be cited as the Medicines (Child Safety) Regulations 2003 and shall come into force on 2003. (2) In these Regulations– “placed on the market” has the same meaning as in regulation 3 of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(a); “relevant medicinal products” means medicinal products for human use consisting of or containing aspirin, paracetamol or more than 24mg of elemental iron which are in dosage unit form of tablets, capsules, pills, lozenges, pastilles, cachets, suppositories or oral liquids, except for- (a) effervescent tablets containing not more than 25 percent of aspirin or paracetamol by weight; (b) medicinal products which are not intended for- (i) retail sale (including sale by a retail pharmacy business), or (ii) supply (including supply in pursuance of a prescription) in circumstances corresponding to retail sale; and (c) medicinal products which are for exportation only; “United Kingdom marketing authorization” has the meaning given in regulation 1(2) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(b).

Child resistant containers for relevant medicinal products

a () S.I. 1994/3144; to which there are amendments which are not relevant to this definition. b () The relevant amending instrument is S.I. 2001/795.

MCA/PL/MLX291 6 2.-(1) Subject to regulation 4, the sale or supply of relevant medicinal products otherwise than in containers that are both opaque or dark tinted and child resistant is prohibited. (2) For the purposes of paragraph (1), containers are child resistant– (a) in the case of non-reclosable containers, if they have been evaluated in accordance with, and comply with the requirements of, British Standard BS 8404 published by the British Standards Institution on 21st December 2001; and

(b) in the case of reclosable containers, if they have been evaluated in accordance with, and comply with the requirements of British Standard EN 28317 published by the British Standards Institution on 15th February 1993.

Size of containers for relevant medicinal products for children 3.-(1) Without prejudice to the requirements of regulation 8 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980(a) (pack size on retail sale or supply of certain medicinal products on a general sale list) and subject to regulation 4, the sale or supply of relevant medicinal products, if they are for administration exclusively to children, otherwise than in a container of an appropriate size, is prohibited. (2) For the purposes of paragraph (1), containers are of an appropriate size- (a) in the case of non-reclosable containers, if the total number of dosage units contained in the package in which they are enclosed does not exceed 25; and (b) in the case of reclosable containers, if the total number of dosage units they contain does not exceed 25, and for these purposes, a dosage unit of a medicinal product in oral liquid dosage form is the smallest recommended dose for that product.

Exemptions from regulations 2 and 3

4.-(1) Regulations 2 and 3 shall not apply to the retail sale (including sale by a retail pharmacy business), or to the supply (including supply in pursuance of a

a () S.I. 1980/1923; the relevant amending instruments are S.I. 1990/1124, 1994/2411, and 1997/1831 and 2045.

MCA/PL/MLX291 7 prescription) in circumstances corresponding to retail sale, of relevant medicinal products by or under the supervision of a pharmacist on premises which are a registered pharmacy, if that sale or supply is-

(a) in accordance with a prescription given by a practitioner, and it is not possible to provide the relevant medicinal products so ordered without breaching regulation 2 or 3; or

(b) at the request of a person, not being a child, who-

(i) specifically requests that the relevant medicinal products not be contained in a child resistant container, and

(ii) is present in the pharmacy at the time of the request.

(2) Regulations 2 and 3 shall not apply to the sale or supply of relevant medicinal products-

(a) by a doctor or dentist either to a patient of his or to a person under whose care a patient of his is in circumstances where the relevant medicinal products are for his patient;

(b) by a doctor or dentist at the request of and to another doctor or dentist for administration to a particular patient of that other doctor or dentist; or

(c) in the course of the business of a hospital or health centre, where the sale or supply is for the purpose of administration, whether in the hospital or health centre or elsewhere, in accordance with the directions of a doctor or dentist.

Colouring of aspirin and paracetamol products for children

5.-(1) Subject to paragraph (2), the sale or supply of relevant medicinal products, if they are for administration exclusively to children, of any colour other than white is prohibited.

(2) Paragraph (1) shall not apply to the sale or supply of relevant medicinal products consisting of or containing either paracetamol in oral liquid dosage form or more than 24mg of elemental iron.

MCA/PL/MLX291 8 Offences

6. Any person who contravenes section 87(2) of the Medicines Act 1968 by contravening any requirement imposed by these Regulations shall be guilty of an offence and shall be liable-

(a) on summary conviction to a fine not exceeding the statutory maximum; and

(b) on conviction on indictment to a fine or to imprisonment for a term not exceeding 2 years or both.

Transitional provisions 7.-(1) These Regulations shall not be applied in respect of relevant medicinal products consisting of or containing either paracetamol in oral liquid dosage form or more than 24mg of elemental iron if- (a) in respect of those products, a United Kingdom marketing authorization was granted by the licensing authority before the coming into force of these Regulations; (b) they were placed on the market before XX October 2003; and (c) their shelf life has not expired. (2) The prohibition, by virtue of regulation 2(1), of the sale or supply of relevant medicinal products otherwise than in containers which are (for the purposes of regulation 2(1)) child resistant shall not be applied in respect of relevant medicinal products in non-reclosable containers if- (a) in respect of those products, a United Kingdom marketing authorization was granted by the licensing authority before the coming into force of these Regulations; (b) they were placed on the market before XX October 2003; (c) their shelf life has not expired; and (d) they are in non-reclosable containers which are in fact child resistant, notwithstanding that they have not been evaluated in accordance with, or do not comply with the requirements of, British Standard BS 8404 published by the British Standards Institution on 21st December 2001.

MCA/PL/MLX291 9 Revocation 8. The following provisions are hereby revoked- (a) the Medicines (Child Safety) Regulations 1975(a); (b) the Medicines (Child Safety) Amendment Regulations 1976(b); (c) the Medicines (Child Safety) Amendment Regulations 1987(c); (d) the Medicines (Child Safety) Amendment Regulations 1994(d); and (e) paragraph 2 of Schedule 7 to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(e).

Signed by authority of the Secretary of State for Health

Parliamentary Under Secretary of State

2003 Department of Health

Permanent Secretary

2003 Department of Health, Social Services and Public Safety

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations contain measures relating to the packaging of medicinal products consisting of or containing aspirin, paracetamol or more than 24mg of elemental iron, and a measure relating to the colouring of solid dosage forms of aspirin and paracetamol.

a () S.I. 1975/2000. b () S.I. 1976/1643. c () S.I. 1987/877. d () S.I. 1994/1402. e () There are no relevant amending instruments.

MCA/PL/MLX291 10 Medicinal products that come within the scope of these Regulations have to be packaged in containers which are child resistant, which is defined with reference to two British Standards Institution standards (regulation 2). There are also limitations on the size of containers for such products, if they are for administration exclusively to children (regulation 3). However, there are exemptions from regulations 2 and 3 for certain products dispensed by pharmacists or supplied by doctors or dentists (regulation 4).

Solid dosage forms of aspirin or paracetamol have to be coloured white (regulation 5), and breaches of the requirements of these Regulations are made an offence (regulation 6). There are transitional provisions in respect of products that come within the scope of these Regulations but did not come within the scope of the Medicines (Child Safety) Regulations 1975 (regulation 7), and those Regulations are revoked along with the spent provisions containing the various amendments to them (regulation 8). These Regulations have been notified to the European Commission and other member States of the European Community in accordance with Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations and rules on Information Society services(a), as amended(b). A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. The British Standards referred to in these Regulations may be obtained from any of the sales outlets operated by the British Standards Institution or by post from the British Standards Institution at Linford Wood, Milton Keynes MK14 6LE.

a () OJ No. L 204, 21.7.1998, p.37. b () See Directive 98/48/EC (OJ No. L 217, 5.8.1998, p.18).

MCA/PL/MLX291 11 Annex B

DRAFT REGULATORY IMPACT ASSESSMENT

CHILD RESISTANT PACKAGING: INTRODUCTION OF A NEW STANDARD FOR CHILD RESISTANT PACKAGING.

Purpose and intended effect of the measures

The Issue Implementing British Standard BS8404 into UK law by introducing new Regulations. These new Regulations will also extend existing packaging requirements in order to introduce additional safeguards for the packaging of medicines containing in excess of 24mg of elemental iron and liquid paracetamol preparations.

Objective The aim of the proposal is to ensure that Marketing Authorisation Holders (MAH’s) comply with British Standard BS8404, which introduces a new standard for blister packs and to add 24mg of elemental iron and liquid paracetamol to the existing requirements for child resistant packaging. We propose to make the standard binding for new applications for MA’s and have a transitional period for any relevant changes to existing MA’s to be made. In addition to introducing the Standard, we also propose to add medicines containing greater than 24mg of elemental iron and all liquid paracetamol preparations to the substances included in the scope of both the new and the existing requirements.

Background The Medicines (Child Safety) Regulations 1975 (as amended) require medicines containing solid oral dosage forms of aspirin/and or paracetamol to be packaged in containers which are resistant to opening by children. Reclosable containers must generally comply with BSEN28317, and non-reclosable containers, such as strip or blister packaging, must have been chosen with a view to their resistance to opening by children.

Although the British Standard for reclosable containers for pharmaceuticals has been in existence for many years, there has been no similar standard for blister or strip packs. In 1989 the British Standards Institute in conjunction with the pharmaceutical industry produced a Code of Practice for non-reclosable packaging for solid dosage units of medicinal products (BS7236). The Code aims to form a practical basis for the development of packaging with acceptable child resistant features but it is not legally binding. Although the existing regulation talks about “containers selected with a view to their resistance to opening by children” there has been no specific standard linked to this requirement.

MCA/PL/MLX291 12 Within Europe, the Comite European De Normalisation (CEN) is developing a standard to cover the testing of blister packs for pharmaceuticals for child resistance and work on this is still progressing.

In addition, the Committee on Safety of Medicines has advised that, the requirement for child resistant packaging should be extended to include medicines containing in excess of 24mg of elemental iron and liquid paracetamol preparations.

The Medicines (Child Safety) Regulations 1975 (as amended) require the pack sizes of medicines in non reclosable and reclosable containers, that are intended for administration exclusively to children to not exceed 25 dosage units. We are proposing to keep this restriction in the new Regulations.

In updating and consolidating the Regulations we are also taking the opportunity to remove reference to BS 6652.

Options Two options have been identified:

Option 1 - Do nothing

Option 2 - Introduce new Regulations to incorporate the British Standard BS8404 on child resistant packaging and extending the scope of the Regulations to include the packaging of products containing liquid paracetamol and elemental iron.

Benefits Identified and Quantified Option 1 - None

Option 2 - All medicines containing aspirin, solid/liquid paracetamol and iron (>24mg) will be packaged in child resistant blister packs which comply with the standard BS8404 with the aim of reducing accidental poisonings in the child population.

Compliance Costs for Business Option 1- No associated costs but would do nothing to reduce the risks of accidental poisonings in the child population.

Option 2 - The principle cost in terms of work will be the requirement of all MAH’s with MA’s for these products to comply with the new regulation by the time the product expires. There are 140 MA’s for aspirin products affecting 52 MAH’s, 348 MA’s for paracetamol products affecting 87 MAH’s and 51 MA’s for iron products affecting 30 MAH’s. The additional cost of producing child resistant blister packs for new applications for MA’s must be weighed against the public health benefits.

MCA/PL/MLX291 13 Business Sector Affected MAH’s of products containing aspirin, liquid/solid paracetamol and iron (>24mg). The final version of this RIA will include an assessment of the impact on MAH’s of this proposal based on responses to this consultation.

Contact point For further information please contact: Jeremy Mean POST-LICENSING DIVISION Medicines Control Agency * 14-111 Market Towers,1 Nine Elms Lane, LONDON SW8 5NQ ( 020 7273 0494 020 7273 0293

MCA/PL/MLX291 14 Annex C

CHILD RESISTANT PACKAGING FOR ASPIRIN AND PARACETAMOL

THE COMPETITION FILTER

Q1: In the market (s) affected by the new regulation, does any firm have more than 10% market share?

A: NO*

Q2: In the market(s) affected by the new regulation, does any firm have more than 20% market share?

A: NO

Q3 In the markets(s) affected by the new regulation, do the largest three firms together have at least 50% market share?

A: NO

Q4: Would the costs of the regulation affect some firms substantially more than others?

A: NO

Q5 Is the regulation likely to affect the market structure, changing the number or size of firms?

A: NO

Q6: Would the regulation lead to higher set-up costs for new or potential firms that existing firms do not have to meet?

A: NO

Q7: Would the regulation lead to higher ongoing costs for new or potential firms that existing firms do not have to meet?

A: NO

Q8: Is the market characterised by rapid technological change?

A: NO

Q9: Would the regulation restrict the ability of firms to choose the price, quality, range of their products?

A: NO

*We currently have no data on the market share of products containing >24mg of elemental iron. 15 However a negative competitive impact is unlikely. CONCLUSION

 The introduction of the new regulation will affect all Marketing Authorisation Holder’s (MAH’s) with Marketing Authorisation’s (MA’s) for aspirin, paracetamol and iron. The affects however, will be equal for all concerned.

 In relation to aspirin and paracetamol no pharmaceutical company has more than 10 % of the market share and therefore no company is likely to have a degree of market power.

 The principle cost in terms of work will be the requirement of all MAH’s with MA’s for these products to comply with the new regulation, by the time the product expires. The additional cost of producing child resistant blister packs for new applications for MA’s will be negligible.

 The market is not characterised by rapid technological change.

 There is unlikely to be a negative competitive impact from the new regulation and no detailed assessment is required.

MCA/PL/MLX291 16 MLX CONSULTATION LIST : MLX 291 Acne Support Group Advanced Life Support Advisory Committee on Misuse of Drugs Age Concern London All Party Pharmacy Group All Party Pro-Choice Group Ambulance Services Association Antroposphical Medical Association Aqueous II (NHS Information Authority) Arthritis Care Association of Anaesthetists of Great Britain and Northern Ireland Association of British Cardiac Nurses Association of British Dispensing Opticians Association of British Health Care Industries Association of British Pharmaceutical Industry (ABPI) Association of Clinical Research in the Pharmaceutical Industry Association of Clinical Research Contractors Association of Community Health Councils of England & Wales Association of Independent Multiple Pharmacies Association of Palliative Medicine Association of Pharmaceutical Importers Association of Professional Ambulance Personnel Association of Respiratory Nurse Specialist Association of Scottish Trusts CP(ASTCP) Association of Surgeons of Great Britain and Ireland Asthma & Allergy Research ATC Ayurvedic Medical Association UK Ayurvedic Trade Association BAAAP BHMA Bio-Health Ltd Bioindustry Association Birth Control Trust British Association for A&E Medicine British Association of Chemical Specialities British Association of Dermatologists British Association of European Distributors British Association of European Pharmaceutical Distributors British Association of Nutritional Therapies British Association of Pharmaceutical Physicians British Association of Pharmaceutical Wholesalers British Association of Research Quality Assurance

MCA/PL/MLX291 17 BBSRC British Cardiac Patients Association British College of Optometrists British Contact Dermatitis Group British Dental Association British Dental Association (Northern Ireland) British Dental Association (Wales) British Dental Association (Scotland) British Dental Trade Association British Diabetic Association British Dietetic Association British Epilepsy Association British Generic Manufacturers Association British Heart Foundation British Herbal Medicines Association British Institute of Regulatory Affairs British Medical Association British Medical Association (Northern Ireland) British Medical Association (Scottish Branch) British Medical Association (Welsh Office) British Menopause Society British Oncological Association British Pharmacological Society (Scotland) British Pharmacological Society (Wales) British Pharmacological Society British Plastics Federation British Pregnancy Advisory Service British Retail Consortium British Society for Allergy British Society for Allergy and Clinical Immunology British Society for Rheumatology British Society of Gastroenterology British Standards Institute British Toxicology Society Brook Advisory Centres Burford Research Camedica Cancer Research Campaign Care Carers National Association Central Medical Advisory Committee CCCPH Cephalon UK Ltd Charity Week

MCA/PL/MLX291 18 Chemist & Druggist Child Safe Packaging Group Chinese Competent Authority Chinese Medical Institute & Register Chiropodists Board CMAS Colgate-Palmolive Ltd Colin Scaife (Packaging Consultant) College of Health College of Optometrists College of Paediatric & Child Health College of Pharmacy Practice Commission for Racial Equality Committee for Practitioners & Health Visitors Association (NI) Common Services Agency Commonwealth Working Group on Traditional & Complementary Health Community Pharmacy Magazine Community Pharmacy Wales Community Practitioners & Health Visitors Association Community Services Pharmacists Group Company Chemist Association Ltd Consolidated Communications Consumers Association Consumers for Health Choice Consumers in Europe Group Co-operative Pharmacy Technical Panel CPHVA CTPA Ltd CWS Ltd (Trade Liaison Department) Department of Agriculture & Rural Development [N Ireland] Department of Health, Social Services & Public Safety - Public Health Branch [N Ireland] Department of Health (UK) Department of Health Commissions Directory Diabetes UK Dispensing Doctors Association Doctor Magazine Drug & Therapeutics Bulletin Drug Information Pharmacists Group DTI – Consumer Safety Unit English Board for Nursing, Midwifery & Health Visiting EISAI Ltd European Association of Hospital Pharmacists ESCOP Secretariat Faculty of Family Planning Faculty of Pharmaceutical Medicine

MCA/PL/MLX291 19 Family Planning Association Family Planning Association (NI) FDC Reports (Elsevier Science) Foundation for Integrated Medicine General Medical Council General Medical Services Committee General Medical Services Committee (Wales) General Practitioners Association (NI) General Practitioners Committee General Practitioners Committee (Wales) Guild of Healthcare Pharmacists HCSA Health Development Agency Health Food Manufacturer’s Association Health Professions Council Health Promotion England Health & Safety Executive Health Service Commissioner Health Which? Heathfield Family Centre Help the Aged HFMA Hoechst Marion Roussel Home Office - Action Against Drugs Unit Icon Regulatory Division IDRAC SAS IFA IHRC Imperial Cancer Research Fund Independent Healthcare Association Institute of Quality Assurance Insulin-Dependent Diabetics Trust International Research Consultants International Planned Parenthood Foundation Irish Veterinary Association Joint Consultants Committee Joint Royal College of Ambulance Service Kings College Hospital Life Local Authority Central Office of Trading Standards (LACOTS) Long-Term Medical Conditions Alliance Lorex Synthelabo UK & Ireland Ltd Medical Defence Union Medical Protection Society Ltd

MCA/PL/MLX291 20 Medical Research Council Medical Toxicology Unit Medical Women's Federation Menarini Pharmaceuticals UK Ltd Ministry of Defence MIMS (Haymarket Medical Publishing Ltd) National AIDS Trust National Assembly for Wales, Health Department National Association of GP Co-operatives National Association of Health Stores National Association of Women Pharmacists National Association of Private Ambulance Service National Back Pain Association National Board for Nursing, Midwifery & Health Visiting (NI) National Consumer Council National Council of Women of GB National Eczema Society National Federation of Women’s Institutes National Meningitis Trust Natural Medicines Manufacturer’s Association UK Natural Medicines Society National Pharmaceutical Association NCH & SPCS Neonatal and Paediatric Pharmacists Group Neurological Alliance NHS Information Authority (Coding & Classification) NHS Pharmaceutical Quality Control Committee NMMA Northern Ireland Ambulance Service Northern Ireland Consumer Council Nursing & Midwifery Council Ophthalmic Group Committee Orphan Europe (UK) Ltd OTC Bulletin OTC Business News (Informa Publishing Group Ltd) OTC News & Market Report Overseas Doctors Association in the UK Ltd Paediatric Chief Pharmacists Group Paramedics Board Patients Association Pharmaceutical Contractors Committee (Northern Ireland) Pharmaceutical Journal Pharmaceutical Quality Group Pharmaceutical Services Negotiating Committee

MCA/PL/MLX291 21 Pharmaceutical Society for Northern Ireland PI Pharma Prescription Pricing Authority Proprietary Association of Great Britain Registered Nursing Home Association Royal College of Anaesthetists Royal College of General Practitioners Royal College of General Practitioners (NI) Royal College of Midwives Royal College of Nursing Royal College of Nursing (Northern Ireland) Royal College of Nursing (Wales) Royal College of Nursing (Scotland) Royal College of Obstetricians & Gynaecologists Royal College of Ophthalmologists Royal College of Paediatricians and Child Health Royal College of Pathologists Royal College of Physicians & Surgeons (Glasgow) Royal College of Physicians (Edinburgh) Royal College of Physicians (London) Royal College of Psychiatrists Royal College of Radiologists Royal College of Surgeons (Edinburgh) Royal College of Surgeons (England) Royal College of Surgeons (Faculty of Dental Surgery) Royal Colleges of Physicians: Faculty of Pharmaceutical Medicine Royal Colleges of Physicians: Faculty of Public Health Medicine Royal Pharmaceutical Society of Great Britain Royal Pharmaceutical Society of Great Britain (Wales) Royal Pharmaceutical Society of Great Britain (Scotland) Royal Pharmaceutical Society of Great Britain (Welsh Executive) Royal Society of Chemistry Sangstat UK Ltd Scottish Ambulance Services Scottish Association of Health Councils Scottish Biomedical Association Scottish Consumer Council Scottish General Practitioners committee Scottish Executive, Department of Health Scottish General Medical Services Committee Scottish Pharmaceutical General Council Scottish Wholesale Druggists Association Scrip Ltd Social Audit Unit

MCA/PL/MLX291 22 Society of Pharmaceutical Medicine St Andrew’s Ambulance St John Ambulance St John Ambulance (NI) TAPASI Terrance Higgins Trust The British Thoracic Society The Foundation for the Study of Infant Deaths The Society of Chiropodists & Podiatrists Third Sector Tutsells Enterprise IG (The Brand Union Limited) UK Committee for Nursing, Midwifery & Health Visiting UK Clinical Pharmacy Association UK Inter-Professional Group Ulster chemist Review University of Aberdeen: Department of General Practice & Primary Care URIACH & CIE SA Veterinary Medicines Directorate (VMD) Welsh Consumer Council Women in Medicine Women’s National Commission

MCA/PL/MLX291 23