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

13.—(1) This paragraph applies where, before 30th October 2005—

(a) the appropriate committee—

(i) have been consulted under paragraph 5 of Schedule 2 to the Marketing Authorization Regulations; and

(ii) have not given a provisional opinion in accordance with paragraph 6 of that Schedule; and

(b) the licensing authority have not notified the applicant or holder of a decision, or of any proposals.

(2) If the licensing authority—

(a) propose to refuse to grant or renew the authorization, or grant it otherwise than in accordance with the application; or

(b) propose to revoke, vary or suspend the authorization,

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

(3) If the applicant or holder is so notified, he may within the time allowed—

(a) give notice to the licensing authority of his wish to appear before and be heard by a person appointed by the licensing authority with respect to those proposals; or

(b) make written representations to the licensing authority.