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NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES -- COST RECOVERY) REGULATIONS 2009 (SLI NO 372 OF 2009) - REG 3.8

Notification

         (1)   The Department must notify an applicant in writing, within 14 days after the occurrence of the following events:

                (a)    the day any of the following come into effect:

                          (i)    an agreement mentioned in subparagraph 3.1 (b) (i), (iii) or (iv);

                         (ii)    a determination mentioned in subparagraph 3.1 (b) (ii);

               (b)    if a price mentioned in subparagraph 3.1 (b) (iii) is recommended -- the day of the recommendation;

                (c)    any decision made about a pricing category by the Secretary under Division 3.2;

               (d)    if the applicant requests a fee exemption or waiver under Part 5 relating to a pricing fee -- a decision about the request.

         (2)   The notification must include information about the applicant's review rights under Part 6.

         (3)   The pricing fee for the application, or any part of the fee that has not been waived, is payable to the Department unless:

                (a)    a fee exemption is granted; or

               (b)    the fee is waived in its entirety.

   



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