Paragraph 7 Authorisation of manufacturers and distributors of feedingstuffs containing medicinal premixesF11F12E1

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^f1 the competent authority is the Secretary of State.

No person may incorporate a F1medicinal premix into F2an intermediate feedingstuff or feedingstuff, or act as a distributor of F3intermediate feedingstuffs or feedingstuffs containing a medicinal premix, without being F4authorised to do so by the Secretary of State.

The conditions which govern F5authorisation of feed business F6premises under Regulation (EC) No 183/2005 laying down requirements for feed hygiene^f2 also govern authorisation of manufacturers and distributors under sub-paragraph (2).

The Secretary of State shall conduct inspections of manufacturers and distributors F7authorised 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.

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.

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 F9medicinal premix annually for that purpose.

In the case of the refusal, suspension or revocation of an F10authorisation under this paragraph the appeals procedure relating to a manufacturing authorisation in regulation 30 applies.