Statutory Instruments
MEDICINES
Made
25th July 1997
Laid before Parliament
28th July 1997
Coming into force
18th August 1997
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 66(1)(i) and 129(1) 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:
1.—(1) These Regulations may be cited as the Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 1997 and shall come into force on 18th August 1997.
(2) In these Regulations, “the principal Regulations” means the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980(3).
(3) In these Regulations, a reference to a numbered regulation or a numbered Schedule is a reference to the regulation in or Schedule to the principal Regulations bearing that number.
2. In regulation 1(2)(a) (citation, commencement and interpretation), the definition of “register” shall be deleted.
3. In regulation 6 (pharmacy records),—
(1) in paragraph (1)(a) there shall be substituted for the word “register”, the words “written or computerised record”; and
(2) in paragraphs (3)(a) and (4)(a) there shall be substituted for the word “register”, the word “record”.
4. In Schedule 2 (particulars in pharmacy records), in paragraph 2(a)(ii) there shall be substituted for the word “register”, the word “record”.
5. Regulation 7 (record keeping in respect of certain veterinary drugs) shall be revoked.
6. In regulation 9 (offences), there shall be substituted for the words “regulations 3, 4, 6 or 7” the words “regulations 3, 4 or 6”.
Signed by authority of the Secretary of State for Health
Baroness Jay
Minister of State,
Department of Health
21st July 1997
Win Griffiths
Parliamentary Under Secretary of State,
Welsh Office
25th July 1997
Sam Galbraith
Parliamentary Under Secretary of State, The Scottish Office
23rd July 1997
Jeff Rooker
Minister of State, Ministry of Agriculture, Fisheries and Food
25th July 1997
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 22nd July 1997.
L.S.
D. C. Gowdy
Permanent Secretary
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 18th July 1997.
L.S.
Mr P. Small
Permanent Secretary
(This note is not part of the Regulations)
These Regulations amend the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 by deleting the definition of “register” and by replacing the references to the “register” in regulation 6 of and Schedule 2 to those Regulations by references to a record, which may be in written or computerised form.
Regulation 5 revokes regulation 7 of those Regulations, which has been superseded by the record-keeping requirements in the Medicines (Veterinary Drugs) (Pharmacy and Merchants' List) Order 1992 (S.I. 1992/33) and regulation 6 amends regulation 9 of those Regulations to reflect the revocation of regulation 7.
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” 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).
S.I. 1980/1923, to which there are amendments not relevant to these Regulations.