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The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

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Regulation 12(1)

SCHEDULE 3PROCEDURE WHERE THE MINISTERS PROPOSE TO TAKE CERTAIN ACTION ON GROUNDS OTHER THAN GROUNDS RELATING TO SAFETY OR QUALITY

1.—(1) Where the Ministers propose to act in a manner specified in regulation 12(1) (in this Schedule called “the proposed regulation 12(1) action”), the Ministers shall not take such action unless, before doing so, they serve a notice complying with the requirements of sub-paragraph (2) on the applicant, or the person responsible for marketing the product, as the case may be.

(2) A notice served by the Ministers under sub-paragraph (1) shall—

(a)state what regulation 12(1) action the Ministers propose to take,

(b)state their reasons for proposing to take such action, and

(c)specify that, on or before the response date specified in such notice, the person on whom such notice is served make written representations to the Ministers with respect to the proposed action.

2. Where a person on whom a notice is served makes written representations to the Ministers on or before the response date specified in the notice, the Ministers shall consider those representations before determining whether to take the proposed regulation 12(1) action.

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