Article 3
1
Member States shall prescribe that, as regards the medicinal component, medicated feedingstuffs may be manufactured from authorized medicated pre-mixes only.
By way of derogation from the first subparagraph, Member States may, provided they comply with the requirements of Article 4 (4) of Directive 81/851/EEC:
- subject to any specific conditions laid down in authorizations to place authorized medicated pre-mixes on the market, authorize intermediate products which are prepared from such medicated pre-mixes authorized in accordance with Article 4 of Directive 81/851/EEC and from one or more feedingstuffs and which are intended for the subsequent manufacture of medicated feedingstuffs ready for use.
Member States shall take all necessary steps to ensure that intermediate products are manufactured only by establishments authorized in accordance with Article 4 and that they are the subject of a declaration to the competent authority,
- authorize the veterinarian to have manufactured under the conditions laid down in Article 4 (3) of Directive 81/851/EEC, and under his responsibility and on prescription, medicated feedingstuffs from several authorized medicated pre-mixes, provided that there is no specific authorized therapeutic agent in pre-mix form for the disease to be treated or for the species concerned.
Until the date on which the Member States have to comply with the new rules laid down in Article 4 (3) of Directive 81/851/EEC, national rules governing the above conditions shall remain applicable, with due regard for the general provisions of the Treaty.
2
Products authorized pursuant to paragraph 1 shall be subject to the rules laid down in Articles 24 to 50 of Directive 81/851/EEC.