Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) The following persons must provide a report to the Secretary every 6 months:
(a) a delegate under subsection 57(3) of the Act;
(b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;
(c) a sponsor of therapeutic goods in relation to which any of the following applies:
(i) an exemption under section 18, 32CA or 41HA of the Act;
(ii) an approval under section 19, 32CK or 41HB of the Act;
(iii) an authority under section 19, 32CM or 41HC of the Act.
(2) The report must be in a form approved by the Secretary.
(3) A report by a person mentioned in paragraph (1)(a) must:
(a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and
(b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.
(4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.
(5) A report by a sponsor of therapeutic goods must:
(a) list each kind of therapeutic goods supplied by the sponsor during the period to which the report relates; and
(b) state the number of times therapeutic goods have been supplied to health practitioners, and the quantity supplied:
(i) to which section 18, subsection 32CA(2) or section 41HA of the Act applies; and
(ii) to which paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act applies; and
(iii) to which paragraph 19(1)(b), 32CK(1)(e) or 41HB(1)(e) of the Act applies; and
(iv) to which subsection 19(5), 32CM(1) or 41HC(1) of the Act applies; and
(v) to which rules made under subsection 19(7A), 32CM(7A) or 41HC(6) of the Act apply.