Paragraph 1 Applications for, or proposals in relation to, marketing authorizations, where appropriate committee has given provisional opinion before 30th October 2005

Paragraphs 2 to 6 apply where, before 30th October 2005—

(a)

the licensing authority have consulted a committee established under section 4 of the Act in relation to a marketing authorization, in accordance with paragraph 5 of Schedule 2 to the Marketing Authorization Regulations;

(b)

the committee have sent notification to the applicant for, or holder of, that marketing authorization—

(i)

under paragraph 6(1)(a) of Schedule 2 to the Marketing Authorization Regulations, that they may be unable to advise the licensing authority to grant or renew the authorization;

(ii)

under paragraph 6(1)(b) of that Schedule, that they may be unable to grant it unless it contains provisions otherwise than in accordance with the application; or

(iii)

under paragraph 6(1)(c) of that Schedule, that they may have to advise the licensing authority that the authorization ought to be revoked, varied or suspended; and

(c)

the committee have not reported findings and advice to the licensing authority in relation to the application, or the proposal to suspend, revoke or vary the authorization.