Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 16V

Application for biologicals (priority applicant) determination

  (1)   A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.

  (2)   An application under subregulation (1) must:

  (a)   be in writing; and

  (b)   be in a form approved, in writing, by the Secretary; and

  (c)   have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.

  (3)   An application under subregulation (1) is taken to not have been made unless:

  (a)   the application meets the requirements in subregulation (2); and

  (b)   the fee prescribed in item   2A in Part   2 of Schedule   9A for making the application has been paid.


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