Commonwealth Numbered Regulations Commonwealth Numbered Regulations
Therapeutic Goods Regulations 1990
1 Regulation 2
Insert:
"generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine" ):
(a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and
(b) has the same pharmaceutical form; and
(c) is bioequivalent; and
(d) has the same safety and efficacy properties.
2 Regulation 10AA
Omit "A kind", substitute "(1) A kind".
3 At the end of regulation 10AA
Add:
(2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.
4 Division 1 of Part 3A (heading)
Repeal the heading, substitute:
5 After regulation 16A
Insert:
Division 1A -- Goods mentioned in Part 1 of Schedule 10
6 Regulations 16B to 16D
Repeal the regulations, substitute:
Application of this regulation
(1) This regulation applies if the Secretary receives an application:
(a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and
(b) to which regulation 16G does not apply.
Giving notification of effectiveness of application
(2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.
Period for completing evaluation in relation to application
(3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:
(a) if the conditions mentioned in subregulations 16DA(1) and (2) are satisfied--120 working days; or
(b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied--175 working days; or
(c) otherwise--255 working days;
beginning on the day the Secretary sends the notification that states that the application is effective.
Application of this regulation
(1) This regulation applies if the Secretary receives an application:
(a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and
(b) to which regulation 16F does not apply.
Giving notification of effectiveness of application
(2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.
Period for completing evaluation in relation to application
(3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:
(a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied--120 working days; or
(b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied--175 working days; or
(c) otherwise--255 working days;
beginning on the day the Secretary sends the notification that states that the application is effective.
16DA Conditions for periods for regulations 16C and 16D
Conditions for 175 day period
(1) For the purposes of paragraphs 16C(3)(b) and 16D(3)(b), the conditions are the following:
(a) the evaluation relates to a medicine (the evaluation medicine ) that is the same as a medicine (an acceptable foreign approved medicine ) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;
(b) the approval for the acceptable foreign approved medicine:
(i) is in force; and
(ii) was given not more than 12 months before the date of the application in relation to the evaluation;
(c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;
(d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;
(e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;
(f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;
(g) if the evaluation medicine is a generic product in comparison to a registered medicine:
(i) the indications of the evaluation medicine are identical to the indications of the registered medicine; and
(ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;
(h) if the evaluation medicine is a biosimilar in relation to a registered medicine--the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;
(i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;
(j) the assessment mentioned in paragraph (i):
(i) is complete and unredacted; and
(ii) is in English; and
(iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and
(iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and
(v) includes the competent regulatory authority's final decision; and
(vi) includes any certifications or authentications of reports relating to the approval; and
(vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).
Conditions for 120 day period
(2) For the purposes of paragraphs 16C(3)(a) and (b) and 16D(3)(a) and (b), the conditions are the following:
(a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;
(b) if the evaluation medicine is manufactured in Australia--there is evidence that the medicine has been manufactured in accordance with Part 3-3 of the Act;
(c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia--there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;
(d) no additional information is required to complete the evaluation, other than:
(i) the label and product information for the evaluation medicine; and
(ii) the risk management plan (if any) for the evaluation medicine.
Determining foreign countries or foreign jurisdictions
(3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.
7 Regulation 16E (heading)
Repeal the heading, substitute:
16E Applications for variations--effect of failure to decide applications within specified period
8 Regulation 16E
Omit "relevant time stated in paragraph 16D(3)(a) or (b)", substitute "period specified in subregulation 16D(3)".
9 Regulation 16F (heading)
Repeal the heading, substitute:
16F Applications for variations--shorter period for deciding applications
10 Regulation 16G (heading)
Repeal the heading, substitute:
16G Applications for registration--shorter period for completing evaluations
11 Subclause 1(1) of Schedule 9 (definition of generic product )
Repeal the definition.
12 Schedule 10 (note to Schedule heading)
Repeal the note, substitute:
Note: See regulations 16C, 16D, 16F, 16G and 45.