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Guidance 2: Fees and charges for prescription medicines
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.