Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 25AA

             (1)  If:

                     (a)  the Secretary includes restricted medicine in the Register in relation to a person under subparagraph 25(4)(d)(ii); or

                     (b)  an applicant for the registration of medicine (other than restricted medicine) is given a notice of the kind referred to in subparagraph 25(1)(da)(ii) and the Secretary includes the medicine in the Register in relation to the applicant under subparagraph 25(4)(d)(ii);

the product information that is approved under this section in relation to the medicine is the product information referred to in subparagraph 25(4)(d)(ia).

Note:          Subsection (4) deals with variation of the product information.

Transitional

             (2)  If:

                     (a)  at the start of the day the first instrument made under subsection 3(2A) or (2B) takes effect, there is medicine included in the Register in relation to a person; and

                     (b)  before that day, the Secretary, in a notice given under subsection 25(4) to the person in relation to the registration of the medicine, specified the product information that was approved by the Secretary in relation to the medicine;

then that product information (including as varied before that day) is, on and after that day, the product information that is approved under this section in relation to the medicine.

Note:          Subsection (4) deals with variation of the product information.

             (3)  If:

                     (a)  before the day the first instrument made under subsection 3(2A) or (2B) takes effect, a person made an application to include medicine in the Register; and

                     (b)  before that day and in relation to that application, the Secretary, in a notice given under subsection 25(4) to the person, specified the product information that was approved by the Secretary in relation to the medicine; and

                     (c)  on or after that day and in relation to that application, the Secretary includes the medicine in the Register in relation to the person under subparagraph 25(4)(d)(ii);

then that product information (including as varied before that inclusion) is, on and after the day the registration of the medicine commences, the product information that is approved under this section in relation to the medicine.

Note:          Subsection (4) deals with variation of the product information.

Variations

             (4)  If:

                     (a)  there is medicine included in the Register in relation to a person and there is product information approved under this section in relation to the medicine; and

                     (b)  either:

                              (i)  under section 9D, the Secretary varies the entry in the Register in relation to the medicine; or

                             (ii)  there is a change in the conditions to which the inclusion of the medicine is subject; and

                     (c)  as a result of that variation or change, the Secretary is satisfied that a variation to that product information is required;

the Secretary may, by notice in writing given to the person, make any variations that the Secretary considers appropriate to the product information that is approved in relation to the medicine.

             (5)  To avoid doubt, if product information that is approved in relation to medicine is varied under this section, that product information, as varied, becomes the product information that is approved under this section in relation to the medicine.