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

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

4.—(1) When the applicant or holder has submitted the representations and documents referred to in paragraph 3(2), the appropriate committee shall—

(a) take into account the representations and documents which he has provided; and

(b) notify the applicant or holder if, on grounds which are additional to or different from those notified to him before 30th October 2005, they are of the provisional opinion that they—

(i) may be unable to advise the licensing authority to grant or renew the authorization, or may be unable to advise the licensing authority to grant it unless it contains provisions in accordance with the application, or

(ii) may have to advise the licensing authority that the authorization ought to be suspended, revoked or varied.

(2) If the appropriate committee give the notification referred to in sub-paragraph (1)(b)—

(a) they shall state in the notification which, if any, of the grounds notified before 30th October 2005 they consider still apply; and

(b) the provisions of paragraph 8(2) to (7) of Schedule 2 to the Marketing Authorization Regulations shall apply in relation to the grounds set out in the notification, including any grounds notified under paragraph (a).