25AAApproved product information for medicine

#### 25AA Approved product information for medicine (1) The Secretary must approve product information in relation to therapeutic goods if: (a) the Secretary decides, under subsection 25(3), to register the goods; and (b) the goods are: (i) restricted medicine; or (ii) medicine in respect of which the applicant has been given a notice of the kind referred to in subparagraph 25(1)(da)(ii). > Note: Subsection (4) deals with variation of the product information. (1A) However, the Secretary must not approve product information in relation to therapeutic goods under subsection (1) unless the Secretary is satisfied that the product information reflects the basis on which the Secretary decided under subsection 25(3) to register the goods. (1B) If: (a) there is medicine included in the Register in relation to a person and there is no product information approved under this section in relation to the medicine; and (b) the medicine becomes restricted medicine; the Secretary may, by written notice given to the person, require the person to: (c) give the Secretary product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine; and (d) give the Secretary that product information within the period specified in the notice (which must be at least 30 days after the notice is given). (1C) If the person complies with subsection (1B), the Secretary must approve product information in relation to the medicine that reflects the basis on which the medicine is registered at the time of the approval. The Secretary must, by written notice given to the person, set out the product information so approved. > 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) (as in force on that day) 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) (as in force on that day) 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; 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. (4A) Without limiting subsection (4), a variation to the product information is not appropriate unless: (a) if subparagraph (4)(b)(i) applies—the product information, as varied, reflects the basis on which the Secretary decided under section 9D to vary the entry in the Register in relation to the medicine; or (b) if subparagraph (4)(b)(ii) applies—the product information, as varied, reflects the basis on which the Secretary decided under section 28 to change the conditions to which the inclusion of the medicine is subject. (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.