Medicines, Poisons and Therapeutic Goods Regulation 2008
566Medicines advisory committee—referred applications and
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566 Medicines advisory committee—referred applications and review of unfavourable CHO decisions (1) This section applies to an application— (a) for approval to prescribe a controlled medicine referred to the medicines advisory committee under section 562 (1) (d); or (b) under section 565 for review of a decision of the chief health officer on an application for a controlled medicines approval. (2) The medicines advisory committee may, in writing, ask the applicant to give the committee further information about the treatment of the person to whom the application relates not later than a stated reasonable time. (3) After considering the application and any further information provided in accordance with a notice under subsection (2), the medicines advisory committee must— (a) for an application for review of a decision by the chief health officer— (i) recommend that the chief health officer confirm the decision made; or (ii) do both of the following: (A) recommend that the chief health officer revoke the decision made; (B) make a recommendation under paragraph (b) (i), (ii) or (iii); or (b) recommend that the chief health officer— (i) approve the application to prescribe a controlled medicine in the terms applied for; or (ii) approve the application in terms different from those applied for; or
use (iii) refuse to approve the application. Note 1 The medicines advisory committee may recommend that the chief health officer include conditions in the approval (see s 570 (2)). Note 2 The chief health officer must consider the committee’s recommendation (4) A recommendation must be in writing.