6.6 Role of the Nutritional Products Working Party
A limited number of nutritional products (medicinal foods) are listed on the PBS – special infant oral formula and food substitutes to treat inborn errors of metabolism. The PBAC constituted the Nutritional Products Working Party (NPWP) to provide advice to the PBAC on clinical and financial matters in submissions to list these products on the PBS as well as any matters relating to utilisation of PBS-listed nutritional products referred to them by the PBAC.
The NPWP provides advice to the PBAC on clinical and financial matters in the submission. The NPWP may also consider issues from submissions for nutritional products deferred or not recommended by the PBAC.
Applicants seeking to list a new medicinal food on the PBS must provide a Category 3 submission to the PBAC, consistent with the requirements outlined in the PBAC Guidelines for Product Type 2.
Submissions for nutritional products are forwarded to the NPWP for consideration at their meeting. The members meet in week 10 of the PBAC cycle.
6.6.1 How the NPWP provides advice to the PBAC
Applicants receive a copy of the NPWP Advice to the PBAC. The applicant has the option to address issues raised by the NPWP in a pre-PBAC response to the PBAC. This should be no longer than three pages of text. The response must address any issues raised by the NPWP or in the submission. No new information can be provided to the PBAC.