Statutory Instruments
MEDICINES
Made
10th August 1994
Laid before Parliament
18th August 1994
Coming into force
8th September 1994
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Scotland and Wales, 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 by sections 18 and 129(1) and (4) of the Medicines Act 1968(1) and now vested in them(2), after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by the following Regulations in accordance with section 129(6) of that Act, and the Secretary of State and the Minister of Agriculture, Fisheries and Food, being Ministers designated(3) for the purposes of section 2(2) of the European Communities Act 1972 (4) in relation to medicinal products and the common agricultural policy of the Economic Community, acting jointly, in exercise of the powers conferred on them by the said section 2(2), and of all other powers enabling them in that behalf, hereby make the following Regulations:
1. These Regulations, which implement article 1.9 of Council Directive 93/40/EEC amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (5), may be cited as the Medicines (Veterinary Medicinal Products) (Applications for Product Licences) (Amendment) Regulations 1994 and shall come into force on 8th September 1994.
2.—(1) The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993(6) shall be amended in accordance with this Regulation.
(2) In regulation 2(1) (interpretation) for the definition of “Directive 81/851” there shall be substituted the following definition:
““Directive 81/851” means Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products(7) as amended by Council Directives 90/676/EEC (8) and 93/40/EEC;”.
(3) In regulation 4(1) (Requirements as to application) for the words “Subject to paragraphs (2) and (3) below” there shall be substituted the words “Subject to paragraphs (2), (3) and (4) below”.
(4) After paragraph (3) of regulation 4 there shall be added the following paragraph–
“(4) In the circumstances described in article 15.2 of Directive 81/851, an applicant for a product licence shall submit to the licensing authority all relevant data available to the applicant.”.
Tom Sackville
Parliamentary Under Secretary of State,
Department of Health
27th July 1994
Hector Monro
Parliamentary Under Secretary of State,
Scottish Office
27th July 1994
Signed by authority of the Secretary of State for Wales:
Gwilym Jones
Parliamentary Under Secretary of State,
Welsh Office
27th July 1994
In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 3rd August 1994.
William Waldegrave
Minister of Agriculture, Fisheries and Food
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 9th day of August 1994.
L.S.
F. A. Elliott
Permanent Secretary
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 10th day of August 1994.
P. T. Toal
Assistant Secretary
(This note is not part of the Regulations)
These Regulations amend the Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993 (S.I. 1993/2398) so as to implement article 1.9 of Council Directive 93/40/EEC (amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products, OJ No. L214, 24.8.93, p. 31) which article removes and replaces the second paragraph of article 15 of Council Directive 81/851/EEC. They permit an applicant for a product licence for a veterinary medicinal product to submit, in certain circumstances, all relevant data available to him rather than a full data dossier.
1968 c. 67: see the definition of “prescribed” in section 132(1); “the Ministers” referred to in section 129(1) is defined in section 1 (see the following footnote).
In the case of the Secretaries of State concerned with health in England and Wales by virtue of S.I. 1969/388, in the case of the Secretary of State concerned with agriculture in Wales by virtue of S.I. 1978/272 and in the case of the Northern Ireland Departments by virtue of the Northern Ireland Constitution Act 1973 (c. 36) section 40 and Schedule 5, and the Northern Ireland Act 1974 (c. 28) section 1(3) and Schedule 1, paragraph 2(1)(b).
S.I. 1972/1811.
OJ No. L214, 24.8.93, p. 31.
S.I. 1993/2398.
OJ No. L317, 6.11.81, p. 1.
OJ No. L373, 31.12.90, p. 15.