child resistant packaging for aspirin and paracetamol

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 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
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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
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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
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Annex A
Consultation draft: November 2002
STATUTORY INSTRUMENTS
2003 No.
MEDICINES
The Medicines (Child Safety) Regulations 2003
Made - - - - - -
Laid before Parliament
Coming into force -
2003
2003
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).
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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.
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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.
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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)
(2)
is present in the pharmacy at the time of the request.
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.
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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;
(2)
(b)
they were placed on the market before XX October 2003; and
(c)
their shelf life has not expired.
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.
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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)
(b)
(c)
(d)
(e)
S.I. 1975/2000.
S.I. 1976/1643.
S.I. 1987/877.
S.I. 1994/1402.
There are no relevant amending instruments.
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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).
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Annex B
DRAFT REGULATORY IMPACT ASSESSMENT
CHILD RESISTANT PACKAGING: INTRODUCTION
STANDARD FOR CHILD RESISTANT PACKAGING.
OF
A
NEW
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.
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.
MCA/PL/MLX291
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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 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.
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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
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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.
However a negative competitive impact is unlikely.
15
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.
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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
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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
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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
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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
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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
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