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THERAPEUTIC GOODS ACT 1989 - SECT 26AB

Application for listing of certain medicines following efficacy evaluation

             (1)  If:

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

                     (b)  the application passes preliminary assessment; and

                     (c)  the requirements of subsections (2), (3), (4) and (6) have been complied with; and

                     (d)  the medicine is not a medicine which may be listed under section 26A; and

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

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

the Secretary must evaluate the medicine for listing under section 26AE.

             (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 does not contain an ingredient that is not specified in a determination under paragraph 26BB(1)(a); and

                     (e)  if a determination under paragraph 26BB(1)(b) specifies requirements in relation to ingredients being contained in the medicine--none of the requirements have been contravened; and

                      (f)  the medicine conforms to every standard (if any) applicable to the medicine; and

                     (g)  both of the following are complied with in relation to the medicine:

                              (i)  the applicable provisions of the Therapeutic Goods Advertising Code;

                             (ii)  the other requirements (if any) relating to advertising applicable under Part 5-1 or under the regulations; and

                     (h)  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; and

                      (i)  the medicine complies with all prescribed quality or safety criteria that are applicable to the medicine; and

                      (j)  the medicine's specifications comply with any requirements that are prescribed by the regulations for the purposes of this paragraph and that are applicable to the medicine; and

                     (k)  the medicine's label:

                              (i)  complies with any requirements that are prescribed by the regulations for the purposes of this subparagraph and that are applicable to the medicine; and

                             (ii)  does not make a claim that is inconsistent with any claim made by the applicant in relation to the medicine in, or in connection with, the application; and

                      (l)  the applicant holds information or evidence showing the medicine's specifications will be maintained under the conditions set out on the medicine's label until the medicine's expiry date; 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 (2) has effect, in relation to the medicine, as if paragraph (2)(h) were omitted.

             (8)  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)(h) 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.

             (9)  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 (4) does not apply in relation to the medicine.



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