
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 , 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.
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(1) The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993 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 as amended by Council Directives 90/676/EEC 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 1994Hector Monro
Parliamentary Under Secretary of State,
Scottish Office
27th July 1994Signed by authority of the Secretary of State for Wales:
Gwilym Jones
Parliamentary Under Secretary of State,
Welsh Office
27th July 1994In 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.
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
