Document ID: chunk:federal_register_of_legislation:C2024C00632:section:26ab:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 26AB (pt 2/3)
Character Range: 248882–251628

and
 (m) the applicant has available sufficient information to substantiate each claim and each indication proposed to be accepted in relation to the inclusion of the medicine in the Register; and
 (n) the medicine does not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and
 (o) all the manufacturers of the medicine are nominated as manufacturers in the application; and
 (p) the applicant has, with manufacturers of the medicine who are manufacturers of the prescribed kind, written agreements containing such matters as are prescribed; and
 (q) the information included in or with the application is complete and correct.
 (3) The applicant must also certify any other matters prescribed by the regulations for the purposes of this subsection.
 (4) Subject to subsection (9), if a step in the manufacture of the medicine has been carried out outside Australia, the Secretary must have certified, prior to the application being made, that the manufacturing and quality control procedures used in each such step are acceptable.
 (5) In deciding whether to certify for the purposes of subsection (4), the matters that may be taken into account include:
 (a) whether the applicant has provided:
 (i) if a step in the manufacture of the medicine has been carried out in a country that is a member of the European Community or a member of EFTA—an EC/EFTA attestation of conformity in relation to the medicine; or
 (ii) if a step in the manufacture of the medicine has been carried out in a country declared by the Minister under section 3B to be covered by a non‑EC/EFTA MRA—a non‑EC/EFTA attestation of conformity, for the non‑EC/EFTA MRA, in relation to the medicine; or
 (iii) in any other case—an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the medicine is of an acceptable standard; and
 (b) whether the applicant has agreed to provide, if the Secretary considers inspection of the manufacturing procedures used in the manufacture of the medicine to be necessary:
 (i) funds for the carrying out of that inspection by the Department; and
 (ii) evidence that the manufacturer has agreed to such an inspection; and
 (c) whether the applicant has complied with any requirements made by the Secretary under section 31 in relation to the manufacture or preparation of the medicine.
 (6) If the medicine includes any ingredient of animal origin, the Secretary must have certified, prior to the application being made, that he or she is satisfied of the safety of the ingredient.
 (7) If a medicine is exempt from the operation of Part 3‑3 or a person is exempt from the operation of that Part in relation to the manufacture of the medicine, subsection