Document ID: chunk:federal_register_of_legislation:C2024C00632:section:28:p3
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 28 (pt 3/5)
Character Range: 292125–294744

those premises or any thing on those premises that relates to any therapeutic goods; and
 (iii) while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and
 (iv) while on those premises, to inspect, and make copies of, any records kept in compliance with paragraph (c) or (ca); and
 (v) while on those premises, to inspect, and make copies of, any documents that relate to the subject goods; and
 (b) if requested to do so by an authorised person, produce to the person such documents relating to the subject goods as the person requires and allow the person to copy the documents; and
 (c) in relation to each batch of the subject goods—keep a record, at least until the end of the period of 12 months after the expiry date for the goods, of all of the manufacturers involved in the manufacture of that batch; and
 (ca) comply, in relation to the subject goods, with any record‑keeping requirements that are prescribed; and
 (d) if requested to do so by an authorised person, make any record kept in compliance with paragraph (c) or (ca) available to the authorised person for inspection:
 (i) at or before the time the authorised person requests, or (if the authorised person requests) immediately; and
 (ii) either in electronic form or in paper form, as the authorised person requests; and
 (e) comply, in relation to the subject goods, with any reporting requirements that are prescribed; and
 (f) if a manufacturer who was not nominated as a manufacturer of the subject goods in the application for the registration or listing of the goods becomes a manufacturer of the goods—inform the Secretary in writing of that fact, no later than 10 working days after the manufacturer becomes a manufacturer of the goods; and
 (g) if premises that were not nominated as premises to be used in the manufacture of the subject goods in the application become premises used in the manufacture of the goods—inform the Secretary in writing of that fact, no later than 10 working days after the premises are first used for that purpose; and
 (h) deliver a reasonable number of samples of the subject goods if the Secretary so requests:
 (i) within the period specified in the request (which must include at least 10 working days); and
 (ii) in accordance with any other requirements specified in the request; and
 (i) comply, in relation to the subject goods, with a notice given to the person under subsection 25AA(1B).
 (5B) The listing of a medicine under section 26A or 26AE is subject to a condition that:
 (a) each step in the manufacture of the medicine