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Guidance 2: Fees and charges for prescription medicines

12 July 2013

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2.6 Other fees that apply to prescription medicines

2.6.1 Testing and providing advice requested from the Pharmaceutical Benefits Program

The fee category (fee item 18 in Schedule 9 of the Regulations) covers the testing and provision of advice, requested from the Pharmaceutical Benefits Program, before listing on the Pharmaceutical Benefits Listing Program.

2.6.2 Requesting consent under section 14 for goods that do not comply with a standard

Under s. 14 and s. 14A of the Act, sponsors may seek consent from the Secretary to import, supply or export therapeutic goods that do not comply with applicable standards.

Item 1A of Schedule 9 of the Regulations specifies the application fee for processing an application for consent under s. 14 of the Act.

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