The Veterinary Medicines Regulations 2005

Representations to the Veterinary Products Committee

29.—(1) If the Secretary of State, on the grounds of the safety, quality or efficacy of the product intends to—

(a) refuse to grant a marketing authorisation or animal test certificate;

(b) grant one that is different from that which was applied for;

(c) suspend it;

(d) vary it other than on the application of the holder;

(e) refuse to grant a variation applied for by the holder; or

(f) revoke it,

she shall notify the applicant or holder of her intention.

(2) The applicant or holder may within 28 days of the notification give notice that he wishes to make representations to the Veterinary Products Committee concerning the notice.

(3) The Committee shall consider those representations.

(4) The representations may be written or oral, but may not include any data not available to the Secretary of State at the time of her decision.

(5) The Committee shall report in writing to the Secretary of State.

(6) If the appellant so requests, the Secretary of State shall give him a copy of the report.

(7) The Secretary of State shall give to the appellant written notification of her proposed determination and the reasons for it.

(8) A person may make representations concerning the Secretary of State’s proposed determination to a person appointed for the purpose by the Secretary of State.

(9) The appointed person shall consider the representations (but shall not consider any data that was not available to the Secretary of State at the time of her decision) and report in writing, with a recommended course of action, to the Secretary of State.

(10) The Secretary of State shall give written notification of her final determination and the reasons for it.

(11) If the notification concerns suspension of a marketing authorisation, unless the Secretary of State directs otherwise, the suspension shall take effect when the notification is made and shall continue in force until she makes her final determination.