26AEEvaluation and listing of certain medicines

#### 26AE Evaluation and listing of certain medicines Evaluation (1) If: (a) an application is made under section 23 for the listing of a medicine in relation to a person under this section; and (b) the application has passed preliminary assessment; the Secretary must evaluate the medicine having regard to: (c) whether the efficacy of the medicine for the purposes for which it is to be used has been satisfactorily established; and (d) such other matters (if any) as the Secretary considers relevant. > Note: The Secretary must not use restricted information when evaluating the medicine for listing: see section 26AF. (2) If a period in relation to which an evaluation under this section must be completed has been prescribed under paragraph 63(2)(daaaa), the evaluation must be completed within that period. Secretary must decide whether to list medicine (3) After an evaluation under this section of goods has been completed, the Secretary must decide: (a) to list the medicine; or (b) not to list the medicine. Decision to list (4) If the Secretary decides under subsection (3) to list the medicine, the Secretary must, in accordance with subsection (5), notify the applicant in writing of the decision within 28 days of making the decision. (5) The notice must: (a) set out the decision under subsection (3) to list the medicine in relation to the person; and (b) inform the applicant that the medicine will not be included in the Register unless and until the applicant gives the Secretary: (i) the certificate required under subsection 26B(1); or (ii) a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application. (6) If the applicant gives the Secretary the certificate referred to in subparagraph (5)(b)(i) or the notice referred to in subparagraph (5)(b)(ii), the Secretary must: (a) include the medicine in the Register; and (b) give the applicant a certificate of listing. (7) To avoid doubt, if the applicant gives the Secretary the certificate referred to in subparagraph (5)(b)(i) or the notice referred to in subparagraph (5)(b)(ii), the Secretary must include the medicine in the Register under paragraph (3)(a) without inquiring into the correctness of the certificate or the notice. Date listing commences (8) The listing of the medicine commences on the day specified for the purpose in the certificate. Refusal to list medicine (9) If: (a) an application is made for the listing of medicine in relation to a person; and (b) the Secretary decides under subsection (3) not to list the medicine; the Secretary must notify the applicant in writing of the decision, and the reasons for the decision, within 28 days of making the decision.