Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 25AB

  (2)   If:

  (a)   an application is made under section   23 for the registration of therapeutic goods in relation to a person; and

  (aa)   the application has passed preliminary assessment; and

  (b)   the Secretary decides under subsection   25(3) to register the goods;

the Secretary must, in accordance with subsection   (3), notify the applicant in writing of the decision within 28 days of making the decision.

  (3)   The notice must:

  (a)   set out the decision under subsection   25(3) to register the goods; and

  (b)   if the goods are restricted medicine or medicine in respect of which the applicant has been given a notice of the kind referred to in subparagraph   25(1)(da)(ii)--set out the product information approved under subsection   25AA(1) for the medicine; and

  (c)   inform the applicant that the goods 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.

  (4)   If the applicant gives the Secretary the certificate referred to in subparagraph   (3)(c)(i) or the notice referred to in subparagraph   (3)(c)(ii), the Secretary must:

  (a)   include the goods in the Register; and

  (b)   give the applicant a certificate of registration.

  (5)   To avoid doubt, if the applicant gives the Secretary the certificate referred to in subparagraph   (3)(c)(i) or the notice referred to in subparagraph   (3)(c)(ii), the Secretary must include the goods in the Register under paragraph   (4)(a) without inquiring into the correctness of the certificate or the notice.

Date registration commences

  (6)   The registration of therapeutic goods commences on the day specified in the certificate of registration.