PBS Cost Recovery fee requirements for lodgement of submissions in March/April for the July 2010 PBAC Meeting - Reminder
PBS cost recovery fees now apply for applications seeking to list on the PBS or NIP, or to amend existing listings.
PBS cost recovery fees for the evaluation and listing of medicines, vaccines and other products or services, on the PBS and NIP now apply for applications seeking to list on the PBS or NIP, or to amend existing listings.
The operational process of PBS cost recovery is provided for in the sub-ordinate regulations- the National Health (Pharmaceutical and Vaccines- Cost Recovery) Regulations 2009. The regulations define the fee categories, application procedures, fee waiver and fee exemption categories and other supporting information.
A link to the regulations can be found here:
The cut off dates for lodgement of submissions for consideration at the July PBAC meeting are as follows:
- 10 March 2010 (major submissions)
- 23 April 2010 (minor submissions)
It is a requirement that applicants submit, along with the submission, a completed fee application form. This is titled ‘PBS Service Fee Application Form: To Accompany PBAC Submission’. The form is in MS Word format and downloadable to companies to complete and submit with the application.
‘Frequently Asked Questions’ (FAQ’s) for Industry contain relevant information and are updated as required.
The e-mail address PBSCostRecovery@Health.gov.au should be used for ongoing communications relating to fee issues. For usual inquiries regarding the progress of your submission you should use existing communications channels with the PBAC Secretariat.