The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993
These Regulations implement Articles 5 and 5a of Council Directive 81/851EEC (OJ No. L317, 6.11.81, p.1) (“Directive 81/851”) as amended by Council Directive 90/676/EEC (OJ No. L373, 31.12.90, p.15) on the approximation of the laws of the Member States relating to veterinary medicinal products, Council Directive 81/852/EEC (OJ No. L317, 6.11.81, p.16) (“Directive 81/852”) as amended by Council Directive 87/20/EEC (OJ No. L15, 17.1.87, p.34) and Commission Directive 92/18/EEC (OJ No. L97, 10.4.92, p.1) on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products, and Article 2 of Council Directive 90/677/EEC (OJ No. L373, 31.12.90, p.26) (“Directive 90/677”) 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.