Commonwealth Consolidated Regulations

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Application for therapeutic goods (priority applicant) determination

             (1)  A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.

             (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 not to have been made unless:

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

                     (b)  subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.

Note:          Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.

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