US Free Trade Agreement Implementation Act 2004 (120 of 2004)

Schedule 7   Therapeutic goods amendments

Therapeutic Goods Act 1989

1   Subsection 25(3)

Repeal the subsection, substitute:

(3) If:

(a) the therapeutic goods are therapeutic devices; and

(b) the evaluation of the goods for registration has been completed;

the Secretary must:

(c) notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and

(d) if the decision is to register the goods - include the goods in the Register and give the applicant a certificate of registration.

(4) If:

(a) the therapeutic goods are not therapeutic devices; and

(b) the evaluation of the goods for registration has been completed;

the Secretary must:

(c) notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and

(d) if the decision is to register the goods:

(i) notify the applicant in writing that the goods will be included in the Register if the applicant gives the Secretary the certificate required under subsection 26B(1); and

(ii) include the goods in the Register and give the applicant a certificate of registration if the applicant gives the Secretary the certificate required under subsection 26B(1).

To avoid doubt, if the applicant gives the Secretary the certificate required under subsection 26B(1), the Secretary must include the goods in the Register under subparagraph (d)(ii) without inquiring into the correctness of the certificate.

(4A) Civil proceedings do not lie against the Secretary (or a delegate of the Secretary) in respect of loss, damage or injury of any kind suffered by another person as a result of the Secretary (or the delegate) including therapeutic goods in the Register in reliance on a certificate required under subsection 26B(1).