Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) A person may make an application (a pricing application ) for the Commonwealth to provide services ( pricing services ) in assisting the Minister to consider whether to exercise one or more powers, under subsection 85(2), (2A) or (3), paragraph 85(7)(b) or section 85AD, 85B or 85E of the Act, in relation to one or more drugs or medicinal preparations (the relevant drugs or medicinal preparations ) if the Committee has made a positive recommendation, or given positive advice, covering all the relevant drugs or medicinal preparations.
Note: The Committee may make a recommendation or give advice in response to a submission, or otherwise under the Act, for the purpose of assisting the Minister to consider whether to exercise one or more powers under a provision of the Act referred to in this subsection in relation to one or more drugs or medicinal preparations.
(2) If the person has made one or more submissions covering the relevant drugs or medicinal preparations, the person must make a separate pricing application in relation to each submission.
Note 1: A single submission may cover multiple drugs or medicinal preparations only in the circumstances set out in paragraphs 21(2)(a) and (b).
Note 2: A separate pricing application must be made in relation to a drug or medicinal preparation covered by a separate submission to the Committee. Separate fees under section 41 are payable for providing pricing services relating to the drugs or medicinal preparations covered by separate submissions to the Committee.
Note 3: For details about how to make a pricing application, see section 49.