The Medicines (Advisory Bodies) (No. 2) Regulations 2005

Right to be heard by person appointed in relation to marketing authorisation applications or proposals made before 30th October 2005

14.—(1) This paragraph applies where—

(a) before 30th October 2005, the licensing authority have consulted the appropriate committee under paragraph 5 of Schedule 2 to the Marketing Authorization Regulations;

(b) the licensing authority propose, on grounds not relating to safety, quality or efficacy—

(i) not to grant or renew an authorization;

(ii) to grant or renew an authorization otherwise than in accordance with an application, or

(iii) to revoke, vary or suspend an authorization; and

(c) the licensing authority have not notified the applicant or holder of their proposals.

(2) The licensing authority shall notify the applicant or holder of their proposals and the reasons for them.

(3) The applicant or holder may, within the time allowed—

(a) notify the licensing authority that he wishes to be heard by a person appointed by the licensing authority with respect to the proposal;

(b) make written representations to the licensing authority.