Document ID: chunk:federal_register_of_legislation:F2024C00959:reg:71b
Version: federal_register_of_legislation:F2024C00959
Segment Type: reg
Provision Reference: reg 71B
Character Range: 182433–184345

71B  Overseas GMP compliance assessment
 (1) This regulation applies in relation to the registration of a veterinary chemical product if:
 (a) the product is manufactured outside Australia; and
 (b) the product is not prescribed under regulation 59 for the purposes of section 120A of the Code; and
 (c) the registration of the product is subject to a condition that each step in the manufacture of the product complies with any of the following:
 (i) the Code;
 (ii) the manufacturing principles;
 (iii) the Australian GMP Code;
 (iv) any standards that apply to the chemical products;
 (v) any standard determined by the APVMA to be comparable to the manufacturing principles or the Australian GMP Code; and
 (d) the registration of the product is subject to a condition that the holder in relation to the registration must, if directed by the APVMA CEO, give to the APVMA, or arrange for the manufacturer of the product to give to the APVMA, evidence of compliance with the condition mentioned in paragraph (c).
 (2) For paragraph 6(2)(c) of the Act, subregulations (3) and (4) apply if the APVMA CEO has directed the holder to provide evidence of compliance with the condition mentioned in paragraph (1)(c).
 (3) If a GMP audit was carried out, and a report of the audit has been given to the APVMA, the APVMA must assess the report having regard to:
 (a) whether the audit report identified any non‑conformances; and
 (b) whether any non‑conformances identified in the audit report have been rectified following corrective action; and
 (c) any other matters that the APVMA considers relevant.
 (4) The APVMA must:
 (a) assess any evidence of compliance with the condition given to the APVMA by the holder or on behalf of the holder; and
 (b) determine whether the APVMA is satisfied that the condition has been complied with.
 (3) In this regulation:
GMP audit has the meaning given by paragraph 61(8)(a).