The Veterinary Medicines Regulations 2006

Procedure for suspending, etc. a marketing authorisation or animal test certificate

29.—(1) If the Secretary of State suspends a marketing authorisation or an animal test certificate, he must notify the holder immediately, and, unless he directs otherwise, the suspension has immediate effect, and continues in effect until any appeals process under this regulation is completed.

(2) If the suspension is on the grounds of safety, quality or efficacy, the holder may give notice within 28 days that he wishes to make representations to the Veterinary Products Committee.

(3) The Committee must 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 the suspension.

(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 his proposed determination and the reasons for it.

(8) A person may then 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 not available to the Secretary of State at the time of the suspension) 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 his final determination and the reasons for it.

(11) If the Secretary of State, on the grounds of safety, quality or efficacy, 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) vary it other than on the application of the holder;

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

(e) revoke it,

he shall notify the applicant or holder of his intention.

(12) 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, and the procedure governing suspension shall then apply in the same way as it applies to suspension, except that a variation or revocation shall not take effect until the Secretary of State has made a final determination.