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SCHEDULES

SCHEDULE 11Advice and representations

PART 1General procedures

Provisional opinion against authorisation

5.—(1) If the appropriate committee is consulted under paragraph 2(1) it may give a provisional opinion that on grounds relating to safety, quality or efficacy—

(a)it may be unable to advise the licensing authority to grant or renew the UK marketing authorisation or traditional herbal registration;

(b)it may be unable to advise the licensing authority to grant the authorisation or registration unless—

(i)it contains terms other than those in the application, or

(ii)it is granted subject to conditions; or

(c)it may have to advise the licensing authority to revoke, vary or suspend the authorisation or registration.

(2) If the Commission is consulted under paragraph 2(2), it may give a provisional opinion that, on grounds relating to safety or quality—

(a)it may be unable to advise the licensing authority to grant or renew the certificate of registration;

(b)it may be unable to advise the licensing authority to grant the certificate unless—

(i)it contains terms other than those in the application, or

(ii)it is granted subject to conditions; or

(c)it may have to advise the licensing authority to revoke, vary or suspend the certificate.

(3) The appropriate committee must notify the applicant for the grant or renewal or (as the case may be) the holder of the authorisation, certificate or registration in writing of its provisional opinion.