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NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES -- COST RECOVERY) REGULATIONS 2009 (SLI NO 372 OF 2009) - REG 5.2

Waiver of fees

         (1)   An applicant may apply to the Secretary to waive all or part of a fee payable under these Regulations.

         (2)   The Secretary may waive a fee, or part of a fee, payable under these Regulations if the application involves the public interest and payment of the fee would make the application financially unviable.

         (3)   Without limiting subregulation (2), the application involves the public interest if:

                (a)    it concerns a drug, medicinal preparation or vaccine that would represent suitable therapy for a patient population; and

               (b)    the patient population is not large enough to make the application financially viable; and

                (c)    the drug, medicinal preparation or vaccine is to be used:

                          (i)    for palliative care; or

                         (ii)    as a paediatric medicine; or

                         (iii)    for medical treatment of Aboriginal or Torres Strait Islander peoples.

   



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