Statutory Instruments
1999 No. 644
MEDICINES
The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 1999
Made
8th March 1999
Laid before Parliament
10th March 1999
Coming into force
31st March 1999
The Secretary of State concerned with health in England, the Secretaries of State concerned with health and with agriculture in Wales and in Scotland respectively, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of the powers conferred upon them by sections 53(4) and 129(1) and (5) of the Medicines Act 1968(1) or, as the case may be, those conferred by those provisions and now vested in them(2), and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Medicines Commission pursuant to section 129(7) of that Act, hereby make the following Regulations:
Citation and commencement
1. These Regulations may be cited as the Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 1999 and shall come into force on 31st March 1999.
Amendment of regulation 8 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980
2. In regulation 8 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980(3) (pack size on retail sale or supply of certain medicinal products on a general sale list)–
(a)in paragraph (2)–
(i)for sub-paragraph (b) there is substituted–
“(b)in the case of tablets that are not effervescent, where they contain aloxiprin, aspirin or paracetamol or a combination of any or all of those substances, not more than 16 tablets;”,
(ii)for sub-paragraph (d) there is substituted–
“(d)in the case of capsules, where they contain aloxiprin, aspirin or paracetamol or a combination of any or all of those substances, not more than 16 capsules;”; and
(b)in paragraph (2B)(a) and (b) for the words “not more than 12” there are substituted the words “not more than 16”.
Signed by authority of the Secretary of State for Health
Hayman
Parliamentary Under Secretary of State,
Department of Health
4th March 1999
Jon Owen Jones
Parliamentary Under Secretary of State, Welsh Office
8th March 1999
Sam Galbraith
Parliamentary Under Secretary of State, The Scottish Office
8th March 1999
Jeff Rooker
Minister of State, Ministry of Agriculture, Fisheries and Food
5th March 1999
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on
L.S.
D.C. Gowdy
Permanent Secretary
5th March 1999
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on
L.S.
P. Small
Permanent Secretary
2nd March 1999
Explanatory Note
(This note is not part of the Regulations)
These Regulations further amend the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980. The Regulations:
(a)reduce the maximum pack size of non-effervescent tablets and capsules containing aloxiprin on the general sale list which may be sold or supplied from outlets other than registered pharmacies from 25 tablets or capsules to 16; and
(b)provide that medicinal products which contain ibuprofen and which are on the general sale list may be sold or supplied from outlets other than registered pharmacies in containers or packages containing not more than 16 tablets or capsules.
An assessment of the cost to business of complying with these Regulations has been made, copies of which have been placed in the libraries of both Houses of Parliament. Further copies may be obtained from the Department of Health, Medicines Control Agency, Information Centre, Room 1207 Market Towers, 1 Nine Elms Lane, London SW8 5NQ.
1968 c. 67. The expression “the Ministers” is defined in section 1(1) of that Act as amended by S.I. 1969/388, Schedule 1. The word “prescribed” in section 53(4) is defined in section 132(1).
In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); in the case of the Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).