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Terms and Conditions

Terms and Conditions

The prescribing and supply of pharmaceutical benefits is subject to conditions contained in the National Health Act 1953.

The information contained in the attached files is under embargo and is provided on condition that it will not be publicly released before the effective date of the Schedule of Pharmaceutical Benefits. You may undertake limited distribution of this information to finalise materials and ensure availability of your product for the effective listing date. The persons you release this information to must also follow the ‘under embargo’ requirements.

These files are not legal documents and in all cases the legislation is the source document. The legislation can be accessed at http://www.frli.gov.au.

Products available as pharmaceutical benefits must at all times comply with the requirements of the relevant legislation and regulations including the National Health Act 1953 and Australian therapeutic goods legislation.

Details of any changes that affect the product’s Australian Medicines Terminology description and any labelling or pack changes must be provided to the Pricing and Policy Branch.

The Branch must also be kept informed of any supply issues which may impact on availability to consumers.

New brands are subject to guarantee of supply provisions under the National Health Act 1953. Penalties may be applied for failing to comply with the requirements of the National Health Act 1953 and other relevant legislation. It is important that you are aware of your responsibilities.