Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 26A

             (1)  If:

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

                     (b)  the application is accompanied by either:

                              (i)  the certificate required under subsection 26B(1); or

                             (ii)  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

                     (c)  the requirements of subsection (2) and (where applicable) subsection (3) have been complied with; and

                     (d)  the medicine is not export only medicine; and

                     (e)  the medicine is not one that has previously had its registration or listing cancelled;

the Secretary must list the medicine in relation to the person.

          (1A)  To avoid doubt, if:

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

                     (b)  the application is accompanied by either:

                              (i)  the certificate required under subsection 26B(1); or

                             (ii)  a notice that a certificate under that subsection is not required in relation to the application; and

                     (c)  the other requirements in subsection (1) are met;

the Secretary must list the medicine under subsection (1) without inquiring into the correctness of the certificate or the notice.

          (1B)  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) listing a medicine in relation to a person in reliance on a certificate required under subsection 26B(1) or a notice given under subparagraph (1)(b)(ii).

             (2)  The applicant must certify that:

                     (a)  the medicine is eligible for listing; and

                     (b)  the medicine is safe for the purposes for which it is to be used; and

                     (c)  the presentation of the medicine is not unacceptable; and

                     (d)  the medicine conforms to every standard (if any) applicable to the medicine and to every requirement (if any) relating to advertising applicable under Part 5‑1 or under the regulations; and

                     (e)  if the medicine has been manufactured in Australia--each step in the manufacture of the medicine has been carried out by a person who is the holder of a licence to carry out that step granted under section 38; and

                      (f)  the medicine complies with all prescribed quality or safety criteria; and

                     (g)  the medicine does not contain substances that are prohibited imports for the purposes of the Customs Act 1901 ; and

                     (h)  all the manufacturers of the medicine are nominated as manufacturers in the application; and

                      (i)  the applicant has, with manufacturers of the medicine who are manufacturers of the prescribed kind, written agreements containing such matters as are prescribed; and

                      (j)  the applicant holds information or evidence to support any claim that the applicant makes relating to the medicine; and

                     (k)  the information included in or with the application is correct.

             (3)  Subject to subsection (7), 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.

             (4)  In deciding whether so to certify for the purposes of subsection (3), 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

                            (ia)  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

                             (ii)  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.

             (5)  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 (2) has effect, in relation to the medicine, as if paragraph (2)(e) were omitted.

             (6)  If a person (the manufacturer ) is exempt from the operation of Part 3‑3 in relation to a step in the manufacture of a medicine, subsection (2) has effect, in relation to the medicine, as if the reference in paragraph (2)(e) to a person who is the holder of a licence were a reference to the manufacturer to the extent that Part 3‑3 applies to the manufacturer in relation to the manufacture of the medicine.

             (7)  If:

                     (a)  a medicine was made outside Australia; and

                     (b)  had the medicine been made in Australia, it would have been exempt from the operation of Part 3‑3;

subsection (3) does not apply in relation to the medicine.

             (9)  As soon as practicable after a medicine has been listed under this section, the Secretary must give to the applicant a certificate of listing of the medicine. The listing of the medicine commences on the day specified for the purpose in the certificate.