[F1Authorisation] of manufacturers and distributors of feedingstuffs containing [F2medicinal premixes]E+W+S

7.—(1) For the purposes of Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community(1) the competent authority is the Secretary of State.

(2) No person may incorporate a [F3medicinal premix] into [F4an intermediate feedingstuff] or feedingstuff, or act as a distributor of [F5intermediate feedingstuffs] or feedingstuffs containing a [F3medicinal premix], without being [F6authorised] to do so by the Secretary of State.

(3) The conditions which govern [F7authorisation] of feed business [F8premises] under Regulation (EC) No 183/2005 laying down requirements for feed hygiene(2) also govern [F7authorisation] of manufacturers and distributors under sub-paragraph (2).

(4) The Secretary of State shall conduct inspections of manufacturers and distributors [F9authorised] under sub-paragraph (2) basing the frequency of inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

[F10(5) A manufacturer must ensure that, so far as is reasonably practical the medicinal premix is evenly incorporated and homogeneously dispersed throughout the feedingstuffs, taking into account the specific properties of the medicinal premix and the mixing technology employed.]

(6) The provisions of this paragraph do not apply in relation to any person breeding or selling ornamental fish not intended for human consumption provided that the person does not use more than a total of 1kg of [F11medicinal premix] annually for that purpose.

(7) In the case of the refusal, suspension or revocation of an [F12authorisation] under this paragraph the appeals procedure relating to a manufacturing authorisation in regulation 30 applies.

Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal productsN.I.

7.—(1) For the purposes of Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community(1) the competent authority is the Secretary of State.

(2) No person may incorporate a veterinary medicinal product into a premixture or feedingstuff, or act as a distributor of premixtures or feedingstuffs containing a veterinary medicinal product, without being approved to do so by the Secretary of State.

(3) The conditions which govern approval of feed business establishments under Regulation (EC) No 183/2005 laying down requirements for feed hygiene(2) also govern approval of manufacturers and distributors under sub-paragraph (2).

(4) The Secretary of State shall conduct inspections of manufacturers and distributors approved under sub-paragraph (2) basing the frequency of inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

(5) A manufacturer must ensure that, so far as is reasonably practical, the veterinary medicinal product is evenly incorporated throughout the feedingstuffs.

(6) The provisions of this paragraph do not apply in relation to any person breeding or selling ornamental fish not intended for human consumption provided that the person does not use more than a total of 1kg of veterinary medicinal product annually for that purpose.

(7) In the case of the refusal, suspension or revocation of an approval under this paragraph the appeals procedure relating to a manufacturing authorisation in regulation 30 applies.