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

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Licence applications or proposals where appropriate committee has given provisional opinion before 30th October 2005

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

(a)the licensing authority have, in relation to a licence, consulted a committee established under section 4 of the Act in accordance with—

(i)section 20(3) of the Act, or

(ii)paragraph 1 of Schedule 2 to the Act;

(b)the committee have sent notification to the applicant for, or holder of, that licence—

(i)under section 21(1) of the Act, that they may be unable to advise the licensing authority to grant or renew the licence, or may be unable to advise the licensing authority to grant it unless it contains provisions otherwise than in accordance with the application, or

(ii)under paragraph 2 of Schedule 2 to the Act, that they may have to advise the licensing authority that the product licence ought to be suspended, revoked or varied;

(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 licence.

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