Statutory Instruments
MEDICINES
Made
26th November 1982
Laid before Parliament
20th December 1982
Coming into Operation
10th January 1983
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, 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 powers conferred by sections 18(1) and 36(1) of the Medicines Act 1968 (as read with sections 24(4) and 38(3) of that Act respectively) and now vested in them(1) 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 the Medicines Act 1968, hereby make the following regulations:-
1. These regulations may be cited as the Medicines (Renewal Applications for Licences and Certificates) Amendment Regulations 1982 and shall come into operation on 10th January 1983.
2.-(1) Regulation 4 of the Medicines (Renewal Applications for Licences and Certificates) Regulations 1974(2) (particulars to be contained in or to accompany renewal applications) shall be amended in accordance with the following provisions of this regulation.
(2) In paragraph (1) of the said regulation 4-
(a)sub-paragraph (a) shall be omitted; and
(b)in sub-paragraph (b):-
(i)the word "other" shall be omitted; and
(ii)for the words "that Schedule" there shall be substituted the words "the Schedule to these regulations".
Signed by authority of the Secretary of State for Social Services.
Geoffrey Finsberg
Parliamentary Under-Secretary of State
Department of Health and Social Security
16th November 1982
Nicholas Edwards
Secretary of State for Wales
18th November 1982
George Younger
Secretary of State for Scotland
19th November 1982
In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 22nd November 1982.
L.S.
Peter Walker
Minister of Agriculture, Fisheries and Food
Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 25th day of November 1982.
L.S.
N. Dugdale
Permanent Secretary
Sealed with the official seal of the Department of Agriculture for Northern Ireland this 26th day of November 1982.
L.S.
J. A. Young
Permanent Secretary
These Regulations amend regulation 4 of the Medicines (Renewal Applications for Licences and Certificates) Regulations 1974 which makes provision for the particulars which are to be contained in or to accompany an application for the renewal of a licence under section 24 of the Medicines Act 1968 or, as the case may be, of a certificate under section 38 of that Act. The Regulations extend the category of particulars which, with the consent of the licensing authority, may be omitted from a renewal application.
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); and 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).
, to which there is an amendment not relevant to these Regulations.