Commonwealth Consolidated Acts Commonwealth Consolidated ActsExempt goods for use for experimental purposes in humans
(1) If therapeutic goods are exempt under subsection 18(1) from the operation of this Part (except this section and sections 31C to 31F) to allow for their use for experimental purposes in humans, the Secretary may give the sponsor of the goods a written notice requiring the sponsor to give to the Secretary specified information or documents relating to one or more of the following:
(a) the supply of the goods;
(b) the handling of the goods;
(c) the monitoring of the supply of the goods;
(d) the results of the supply of the goods;
(e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.
Statement by medical practitioner about medicine
(2) If a medicine is exempt under subsection 18(1) from the operation of this Part (except this section and sections 31C to 31F) because a medical practitioner has signed a statement in accordance with regulation 12A of the Therapeutic Goods Regulations 1990 , the Secretary may give the medical practitioner a written notice requiring the medical practitioner to give to the Secretary specified information or documents relating to one or more of the following:
(a) the condition of the person to whom the medicine is to be given or is given;
(b) the supply of the medicine;
(c) the handling of the medicine;
(d) the monitoring of the supply of the medicine;
(e) the results of the supply of the medicine;
(f) any other matter prescribed by the regulations for the purposes of this paragraph in relation to medicines of that kind.
Compliance period
(3) A notice under subsection (1) or (2) must specify a reasonable period within which the person to whom the notice is given must comply with it. The period must be at least 14 days starting on the day on which the notice is given.
Information may need to be given in accordance with specified software requirements
(4) A notice under subsection (1) or (2) may require information to be given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.