The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Person appointed to hear representations

9.  If the licensing authority—

(a) determine an application in a way which differs from the advice of the Medicines Commission under paragraph 6, or propose to refuse to renew or propose to revoke, vary or suspend a marketing authorization against such advice, or propose not to alter their decision or propose to continue with their proposal following the advice of the Medicines Commission under paragraph 8; or

(b) where there has been no hearing before, and no representations have been made or referred to, the Medicines Commission, determine an application, or propose to refuse to renew or propose to revoke, vary or suspend a marketing authorization, in a way which differs from the advice of the appropriate committee under paragraph 6; or

(c) in the absence of any such advice as is mentioned in either of the preceding sub-paragraphs, determine an application, or propose to refuse to renew or to revoke, vary or suspend a marketing authorization, in a way which differs from the advice given by the appropriate committee or the Medicines Commission; or

(d) 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 the application; or

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

the licensing authority (in any case where a decision on the application has not already been made, before determining the application) shall notify the applicant or holder accordingly.