(a) 'authorized medicated pre-mix': any pre-mix for the manufacture of medicated feedingstuffs as defined in Article 1 (2) of Directive 81/851/EEC which has been granted an authorization in accordance with Article 4 of that Directive;

- 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.

- 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.

Whereas medicated feedingstuffs must, with regard to the medicinal components, comply with the rules applicable to veterinary medicinal products; whereas, however, in the manufacture of medicated feedingstuffs simple mixing is the main process; whereas only authorized medicated pre-mixes may be used and precise instructions must be given for the use of these medicated feedingstuffs; whereas, in addition, the person responsible for manufacture must have at his disposal sufficient staff and premises so that can meet the requirements of this Directive;

The Directive provides that only authorised medicated pre-mixes may be used to manufacture medicated foodstuffs and that precise instructions must be given for the utilisation of such foodstuffs.

The Directive provides that only authorised medicated pre-mixes may be used to manufacture medicated foodstuffs and that precise instructions must be given for the utilisation of such foodstuffs.