# The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993, Regulation 2: Interpretation


(1) 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 amended by Council Directive 90/676/EEC;
“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 amended by Council Directive 87/20/EEC and Commission Directive 92/18/EEC;
“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;
“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; 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.
(2) 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.

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Source: https://www.legislation.gov.uk/uksi/1993/2398/regulation/2 (the official version)
Page: https://openlegislation.uk/medicines-veterinary-medicinal-products-applications-for-product-licences-regulations-1993/regulation-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

