Therapeutic Goods Act 1989

If:

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

the application has passed preliminary assessment; and

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

The notice must:

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

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

inform the applicant that the goods will not be included in the Register unless and until the applicant gives the Secretary:

the certificate required under subsection 26B(1); or

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.

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; and

give the applicant a certificate of registration.

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.

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