Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 16DA

Conditions for 175 day period

  (1)   For the purposes of paragraphs 16C(3)(a) and (b) and 16D(3)(a) and (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;

  (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 an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;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:

  (aa)   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;

  (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.