The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) (Amendment) Regulations 1994

• Citation: S.I. 1994/2157
• Sections: 2

Section 1 Citation and commencement

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.

Section 2 Amendment to the Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993

(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.