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The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) (Amendment) Regulations 1994
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- 1994 No. 2157
- Explanatory Note
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Explanatory Note
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These Regulations amend the Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993 (S.I. 1993/2398) so as to 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, OJ No. L214, 24.8.93, p. 31) which article removes and replaces the second paragraph of article 15 of Council Directive 81/851/EEC. They permit an applicant for a product licence for a veterinary medicinal product to submit, in certain circumstances, all relevant data available to him rather than a full data dossier.
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