The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994

Refusal, etc., of a marketing authorisation on other grounds

13.—(1) If, in the circumstances where there is no right of appeal under article 21.4 of Council Directive 81/851/EEC, the Ministers propose—

(a) acting in accordance with regulation 5(a) above to refuse to grant a marketing authorisation on any grounds not relating to safety, quality or efficacy, or

(b) acting in accordance with regulation 11 above to suspend or revoke an authorisation on grounds not relating to safety, quality or efficacy,

then before doing so they shall serve notice on the applicant or authorisation holder stating their proposals and the reasons for them and specifying a time within which he may apply to a person appointed by the Ministers under this regulation; except that this paragraph shall not apply if the Ministers are acting in accordance with article 11.3 or 36.3 of Council Directive 81/851/EEC.

(2) If, within the time allowed after the service of a notice under this regulation, the applicant or authorisation holder gives notice to the Ministers of his desire to be heard by the appointed person, or makes representations in writing to the Ministers with respect to their proposals, then, before determining the issue, the Ministers shall afford to him an opportunity of appearing before, and being heard by, a person appointed for the purpose by the Ministers, or shall take those representations into account.

(3) When a person is appointed under this regulation, the provisions of regulation 12(5) above have effect.