Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 25

             (1)  Where:

                     (a)  an application is made for the registration of therapeutic goods in relation to a person in accordance with section 23; and

                     (b)  there is no part of an evaluation fee under section 24 in respect of those goods that:

                              (i)  is due and payable by the person; and

                             (ii)  remains unpaid; and

                     (c)  the person has complied with any requirements made by the Secretary under section 31 in relation to the goods;

the goods are to be evaluated for registration having regard to:

                     (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

                     (e)  whether the presentation of the goods is acceptable; and

                      (f)  whether the goods conform to any standard applicable to the goods, or any requirements relating to advertising applicable under Part 5‑1 or under the regulations; 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

                      (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 the goods are not therapeutic devices and 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 the goods are not therapeutic devices and 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.

          (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)  If:

                     (a)  the therapeutic goods are therapeutic devices; and

                     (b)  the evaluation of the goods for registration has been completed;

the Secretary must:

                     (c)  notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and

                     (d)  if the decision is to register the goods--include the goods in the Register and give the applicant a certificate of registration.

             (4)  If:

                     (a)  the therapeutic goods are not therapeutic devices; and

                     (b)  the evaluation of the goods for registration has been completed;

the Secretary must:

                     (c)  notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and

                     (d)  if the decision is to register the goods:

                              (i)  notify the applicant in writing that the goods will be included in the Register if the applicant gives the Secretary either the certificate required under subsection 26B(1) or a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and

                             (ii)  include the goods in the Register and give the applicant a certificate of registration if the applicant gives the Secretary either the certificate required under subsection 26B(1) or a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application.

To avoid doubt, if the applicant gives the Secretary the certificate required under subsection 26B(1) or a notice that a certificate under that subsection is not required in relation to the application, the Secretary must include the goods in the Register under subparagraph (d)(ii) without inquiring into the correctness of the certificate or the notice.

          (4A)  Civil proceedings do not lie against the Secretary (or a delegate of the Secretary) in respect of loss, damage or injury of any kind suffered by another person as a result of the Secretary (or the delegate) including therapeutic goods in the Register in reliance on a certificate required under subsection 26B(1) or a notice given under subparagraph (4)(d)(ii).

             (5)  The registration of therapeutic goods commences on the day specified for the purpose in the certificate of registration.

             (6)  The failure to complete an evaluation within the period mentioned in subsection (2A) does not render the Commonwealth, the Secretary or a delegate of the Secretary liable to a person in respect of loss, damage or injury of any kind caused by, or arising out of, the failure.