Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) If:
(a) an application is made for the registration of therapeutic goods in relation to a person under section 23; and
(b) the application has passed preliminary assessment;
the Secretary must evaluate the goods for registration having regard to:
(c) unless the application is one referred to in paragraph (d)--whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established; and
(d) for an application for provisional registration of a medicine:
(i) whether, based on preliminary clinical data, the safety and efficacy of the medicine for the purposes for which it is to be used have been satisfactorily established; and
(ii) whether the quality of the medicine for the purposes for which it is to be used has been satisfactorily established; and
(iii) if subsection 23AA(1) applies in relation to the application--whether, if the Secretary were to register the medicine, the Secretary is satisfied with the applicant's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that registration would commence; and
(da) if:
(i) the applicant is applying for the registration of restricted medicine; or
(ii) the applicant is applying for the registration of medicine (other than restricted medicine) and the applicant has been given a notice in writing by the Secretary requiring the applicant to give to the Secretary product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine;
the product information given by the applicant in relation to the medicine; and
(e) whether the presentation of the goods is acceptable; and
(f) whether the goods conform to any standard applicable to the goods; and
(fa) whether:
(i) the applicable provisions of the Therapeutic Goods Advertising Code; and
(ii) the other requirements (if any) relating to advertising applicable under Part 5 - 1 or 5 - 1A or the regulations;
are complied with in relation to the goods; and
(g) if a step in the manufacture of the goods has been carried out outside Australia--whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable; and
(h) if the goods have been manufactured in Australia--whether the goods have been manufactured in accordance with Part 3 - 3; and
(i) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)--whether, if the Secretary were to register the goods, the Secretary is satisfied that imports into Australia, exports from Australia or supplies in Australia of the goods would contravene those prohibitions; and
(ia) if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions--whether, if the Secretary were to register the goods, the Secretary is satisfied that imports into Australia, exports from Australia or supplies in Australia of the goods would contravene those conditions; and
(j) whether the goods contain substances that are prohibited imports for the purposes of the Customs Act 1901 ; and
(ja) whether all of the manufacturers of the goods are nominated as manufacturers of the goods in the application; and
(k) such other matters (if any) as the Secretary considers relevant.
Note: The Secretary must not use protected information when evaluating therapeutic goods for registration: see section 25A.
(2) In making a decision for the purposes of paragraph (1)(g), the matters that may be taken into account include:
(a) whether the applicant has provided:
(i) if a step in the manufacture of the goods 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 goods; or
(ia) if a step in the manufacture of the goods 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 goods; or
(ii) in any other case--an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the goods is of an acceptable standard; and
(b) whether the applicant has agreed to provide, where the Secretary considers inspection of the manufacturing procedures used in the manufacture of the goods 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.
(2AA) If:
(a) the applicant is applying for the registration of a medicine; and
(b) the Secretary has given the applicant or any other person advice under section 22G in relation to the medicine;
the Secretary must have regard to the advice in evaluating the medicine under this section.
(2AB) Subsection (2AA) does not limit the matters the Secretary may take into account in evaluating the medicine under this section.
(2A) An evaluation under this section of goods in relation to which a period has been prescribed under paragraph 63(2)(da) must be completed within that period.
(2B) If therapeutic goods are 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 goods, subsection (1) has effect, in relation to the goods, as if paragraph (h) were omitted.
(2C) If a person is exempt from the operation of Part 3 - 3 in relation to a step in the manufacture of therapeutic goods, subsection (1) has effect, in relation to the goods, as if the reference in paragraph (h) to Part 3 - 3 were a reference to that Part to the extent that it applies to that person in relation to the manufacture of the goods.
(2D) If:
(a) therapeutic goods were made outside Australia; and
(b) had the goods been made in Australia, they would have been exempt from the operation of Part 3 - 3;
subsection (1) has effect, in relation to the goods, as if paragraph (g) were omitted.
(2E) A decision for the purposes of paragraph (1)(g) may also take into account any information provided to the Secretary by a health authority of a Convention country and relating to:
(a) the general standards of manufacturing practice of a particular manufacturer; or
(b) the specific standards of manufacture or control adopted by a particular manufacturer in relation to particular goods.
(2F) For the purposes of subsection (2E), a Convention country is a country that is a party to the Mutual Recognition Convention.
(2G) Information referred to in subsection (2E) and provided in accordance with the Mutual Recognition Convention is to be treated as equivalent to information obtained as a result of an inspection under Part 3 - 3 of this Act.
(3) After an evaluation under this section of goods has been completed, the Secretary must decide:
(a) to register the goods; or
(b) not to register the goods.
Note: See also sections 25AA (approved product information for medicine), 25AB (registration of therapeutic goods) and 25AC (notice of decision not to register therapeutic goods).