Regulation 2 Interpretation

In these Regulations—

• “the Act” means the Medicines Act 1968;

• “application” means a request for the grant of a product licence and shall comprise all the documents submitted in support of it, and “applicant” shall be construed accordingly;

• “Directive 81/851” means Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products^f1 amended by Council Directive 90/676/EEC^f2;

• “Directive 81/852” means Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products^f3 amended by Council Directive 87/20/EEC^f4 and Commission Directive 92/18/EEC^f5;

• “Directive 90/677” means Council Directive 90/677/EEC extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products^f6;

• “immunological product” means a veterinary medicinal product used in order to produce active or passive immunity or to diagnose the state of immunity, to which Directives 81/851 and 90/677 apply;

• “product licence” means a product licence in relation to a veterinary medicinal product to which Directive 81/851 applies;

• “standard provisions for licences” means the relevant standard provisions prescribed by regulations under section 47(1) of the Act^f7; and

• “veterinary medicinal product” has the meaning assigned to that expression in Directive 81/851 and for the purposes of these Regulations shall be treated as a medicinal product within the meaning of section 130 of the Act.

In these Regulations any reference to a numbered regulation or Schedule shall be construed as a reference to the regulation or Schedule so numbered in these Regulations.