Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 16F

Applications for variations--shorter period for deciding applications

  (1)   Subject to subregulation   (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part   1 of Schedule   10, to vary the information in the Register concerning the medicine in relation to:

  (a)   the specifications for the active ingredient, finished product or excipients; or

  (b)   the method of manufacture of the active ingredient; or

  (c)   the manufacturing procedure for the finished product; or

  (d)   the site of manufacture of the active ingredient or the finished product; or

  (e)   the shelf life; or

  (f)   the storage conditions; or

  (g)   the labelling; or

  (h)   any other particular that is not a particular mentioned in subsection   16(1) of the Act.

  (2)   This regulation does not apply to an application that:

  (a)   in the opinion of the Secretary, needs to be supported by clinical, pre - clinical or bio - equivalence data; or

  (b)   applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection   16(1) of the Act.

  (3)   In the case of an application to which this regulation applies, the Secretary must:

  (a)   decide the application and notify the applicant of the decision; or

  (b)   raise an objection concerning the application;

within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.

  (4)   If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant's response to the objection.

  (5)   If the Secretary does not comply with subregulation   (3) and, if applicable, subregulation   (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.


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