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

The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993^f1 shall be amended in accordance with this Regulation.

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^f2 as amended by Council Directives 90/676/EEC ^f3 and 93/40/EEC;”.

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”.

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.”.