Article 1

1. The definitions laid down in Article 1 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (2) shall apply to this Directive. 2. For the purposes of this Directive, the following definitions shall apply: - "veterinary medicinal product" shall mean any medicinal product intended for animals, "ready-made veterinary medicinal product" shall mean any veterinary medicinal product prepared in advance which does not comply with the definition of proprietary medicinal products and which is marketed in a pharmaceutical form which may be used without further processing, "pre-mix for medicated feedingstuffs" shall mean any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs, "medicated feedingstuffs" shall mean any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal product covered by Article 1 (2) of Directive 65/65/EEC. 3. Until Community rules are adopted for medicated feedingstuffs, Member States may lay down that this term shall include semi-finished products which are manufactured from a pre-mix for medicated feedingstuffs for which an authorization pursuant to Article 4 of this Directive has been issued and feedingstuffs, where such semi-finished products are intended to be processed by further mixing with feedingstuffs to become medicated feedingstuffs ready for use. Member States shall ensure that such semi-finished products are subject to the control of the competent authorities and that they are used exclusively for the manufacture of medicated feedingstuffs under the conditions which governed the marketing authorization for the pre-mix for medicated feedingstuffs. 4. Additives covered by Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (3), as subsequently amended, where they are incorporated in animal feedingstuffs and supplementary animal feedingstuffs in accordance with that Directive, shall not be considered as veterinary medicinal products for the purposes of this Directive. 5. Member States shall take any necessary steps to ensure that antibiotics and hormone substances which may be used for the preparation of veterinary medicinal products are made available to only (1) OJ No L 147, 9.6.1975, p. 13. (2) OJ No 22, 9.12.1965, p. 369/65. (3) OJ No L 270, 14.12.1970, p. 1. natural or legal persons duly authorized to be in possession of them under national laws.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.