8.5 Other listing documents required

Page last updated: October 2016

The department requires additional listing documents to have the medicine listed on the PBS Schedule. The deadlines for these documents are provided on the PBS website.

These documents are forwarded to the department by email (refer to contact details in Appendix A).

8.5.1   Letter of application (where applicable)

Where the medicinal product has not been listed on the PBS, the department requires an application letter to be provided by the sponsor. The letter of application should be signed by the responsible persons authorised representative and contain or include:

  • an application to list a medicine or medicinal product as a Pharmaceutical Benefit (form pb11) if this has not already been provided in the submission
  • in the case of listing a brand containing a drug on F2, or drug that will move to F2 on the new brand listing day, any comments a sponsor wishes to provide to the delegate for consideration of whether to make an originator brand determination under s99ADB of the National Health Act 1953 (see sections 5.5 and 5.7)
  • a hyperlink to the TGA-approved Product Information for the medicinal product
  • an assurance of supply (stock assurance - see section 8.5.2)
  • a responsible person form (see section 8.5.3).

For contact information, refer to Appendix A.

8.5.2   Assurance of supply

A new medicinal product should be available for ordering by pharmacies, hospitals or other PBS dispensers so that the product can be ‘in stock’ for dispensing on the first date of listing on the PBS. The cover letter must include an undertaking that sufficient stock of the product to meet demand will be available to allow for delivery to PBS dispensers (e.g. pharmacies, hospitals or other suppliers) in time for the PBS listing day.

Separate to the assurance of supply, brands may be affected by the guarantee of supply provisions in Division 3C of Part VII (ss99AE–99AEL) of the National Health Act 1953. These are intended to deter suppliers from entering the Australian market without a viable business model able to support their long-term participation in the market.

Where applicable, the guarantee of supply applies from the date of listing of the product on the PBS Schedule. Additional details, including the period for which the guarantee provisions apply, are found on the PBS website.

8.5.3   Responsible Person

The Responsible Person is the person or corporation with a registered ABN or ACN that is the supplier of a particular brand of a medicine on the PBS.

A Responsible Person has responsibility under the National Health Act 1953 for:

  • price negotiations and agreements (s85AD)
  • price disclosure (Division 3B)
  • guarantee of supply (Division 3C).

The Act provides for penalties and other sanctions, which may apply if the Responsible Person fails to meet the price disclosure and guarantee of supply obligations.

The PEB requires a completed Responsible Person form, which includes the nomination of an authorised representative, for each product to be listed on the PBS.

Further information can be obtained from the department (refer to contact details in Appendix A).

 

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