Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 45

Reduction of evaluation fee for certain goods--supply in the interest of public health that would otherwise not be commercially viable

  (1)   The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule   9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part   1 of Schedule   10) if the supply of those goods:

  (a)   is in the interest of public health; and

  (b)   would not be commercially viable for the sponsor of the goods if the full amount of the fee were paid.

Waiver or reduction of evaluation fee for certain goods--goods with same active ingredient and common information

  (2)   The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules   9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part   1 of Schedule   10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:

  (a)   the goods to which each application relates contain the same active ingredient;

  (b)   the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.

Waiver or reduction of application and evaluation fees for certain medicines--additional applications for goods with same active ingredient and common information

  (3A)   The Secretary may waive or reduce the application and evaluation fees specified in Schedule   9 that are payable in relation to an application if:

  (a)   the application is of a kind mentioned in subregulation   (3B); and

  (b)   the applicant makes one or more additional applications of the same kind; and

  (c)   each application relates to goods that contain the same therapeutically active ingredient; and

  (d)   the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.

  (3B)   The applications are as follows:

  (a)   an L(A)1 application;

  (b)   an L(A)2 application;

  (c)   an L(A)3 application;

  (d)   an RCM1 application;

  (e)   an RCM2 application;

  (f)   an RCM3 application;

  (g)   an RCM4 application;

  (h)   an RCM5 application.

Waiver or reduction of evaluation fees for certain goods--abridged evaluation procedure

  (4)   The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules   9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part   1 of Schedule   10):

  (a)   to register goods; or

  (aa)   to list goods under section   26AE of the Act; or

  (b)   in relation to registered goods that are a medicine--to vary the information entered in the Register; or

  (c)   to include goods in the part of the Register for biologicals; or

  (d)   for a biological included in the Register under Part   3 - 2A of the Act--to vary the information included in the Register;

if the Secretary has information relating to the goods that enables the evaluation procedure to be abridged.

Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency--abridged evaluation procedure

  (4AA)   The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule   9 in relation to a submission for goods of a kind mentioned in Part   1 of Schedule   10 if, in the Secretary's opinion:

  (a)   supply of the goods in Australia is necessary because of a public health emergency; and

  (b)   the waiver or reduction is necessary to enable the goods to be supplied in Australia; and

  (c)   the Secretary has information relating to the goods that allows the evaluation procedure to be abridged.

Reduction of application and evaluation fees for certain medicines--abridged preliminary assessment and evaluation procedure

  (5)   Subregulation (6) applies in relation to an application made under section   23 of the Act for the registration of a medicine if:

  (a)   the medicine is a product of a kind specified in Part   1 of Schedule   10; and

  (b)   apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and

  (c)   the Secretary is satisfied that:

  (i)   the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and

  (ii)   neither non - clinical nor quality data needs to be evaluated in the evaluation of the medicine for registration; and

  (d)   the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.

  (6)   The Secretary may:

  (a)   reduce the application fees specified in Schedule   9 that are payable in relation to the application to $1,241; and

  (b)   reduce the evaluation fees specified in Schedule   9 that are payable in relation to the application to $4,954.

Fee waivers for prescription opioids

  (7)   The Secretary must waive a fee prescribed in Schedule   9 in relation to a request (an opioid reform request ) that satisfies all of the following:

  (a)   it is made in relation to prescription opioids that are registered goods;

  (b)   it is made in the period beginning on the commencement of this subregulation   and ending at the end of 31   December 2021;

  (c)   it is made under subsection   9D(2) or (3) of the Act;

  (d)   it is made solely for an opioid reform purpose (see subregulation   (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation   (9)).

  (8)   For the purposes of subregulation   (7), an opioid reform request is made for an opioid reform purpose if it is made:

  (a)   under subsection   9D(2) of the Act, to do either or both of the following:

  (i)   add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;

  (ii)   reduce the class of persons for whom the goods are suitable; or

  (b)   under subsection   9D(3) of the Act, to introduce a smaller pack size in relation to the goods.

  (9)   For the purposes of subregulation   (7), an opioid reform request is made for an associated variation of product information purpose if:

  (a)   the opioid reform request is made under subsection   9D(3) of the Act; and

  (b)   paragraphs 9D(3)(b) to (c) of the Act are satisfied in relation to the request; and

  (c)   the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section   7D of the Act in relation to the prescription opioids.

Waiver of application and registration fees for designated orphan drugs

  (12)   The Secretary must waive the following fees:

  (a)   a fee that would have been payable, but for this subregulation, as part of an application under subsection   22C(1) of the Act relating to a medicine that is a designated orphan drug;

  (b)   a fee that would have been payable, but for this subregulation, as part of an application under subsection   22E(3) of the Act relating to a medicine that is a designated orphan drug;

  (c)   a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;

  (d)   a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.

Fee waiver for requests to vary product information for medicine

  (13)   The Secretary must waive a fee prescribed in Schedule   9 in relation to a request that a person makes under subsection   9D(3) of the Act if:

  (a)   the request is in relation to therapeutic goods that are registered; and

  (b)   the therapeutic goods are medicine; and

  (c)   paragraphs 9D(3)(b) to (c) of the Act are satisfied in relation to the request; and

  (d)   the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section   7D of the Act in relation to the medicine; and

  (e)   the request is made in the period beginning on 1   January 2020 and ending at the end of 31   December 2020.