Stoma Appliance Scheme for suppliers

Getting a product on the schedule

The Stoma Product Assessment Panel assesses stoma products and recommends any changes, including new listings, to the Stoma Appliance Scheme Schedule.

The Australian Government makes the final decision about listing of products.

To apply a company must:

• have an Australian Business Number (ABN)
• guarantee supply of the product.

The product must:

• be registered on the Therapeutic Good Administration’s Australian Register of Therapeutic Goods 
• (this does not apply for products that are excluded from TGA regulation such as adhesive removers and non-medicated skin cleansers)
• meet a clinical need
• be either equivalent to or better than products already on the schedule
• be ready to be supplied following approval.

Submission dates

Applications can be sent to the Stoma Product Assessment Panel’s secretariat at any time. The Panel usually meets twice a year to assess applications..

Applications close about 2 months before the meeting date, to ensure adequate processing time.

The Panel meets twice a year to assess applications. The next meeting dates are:

• SPAP meeting – 14 May 2024 (closing date for applications is 22 March 2024)
• SPAP meeting – 12 November 2024 (closing date for applications is 6 September 2024)

Applying

To apply, select the appropriate category for the product, then complete the application form for either groups 1 to 7 or groups 8 to 11. Include all the requested information, such as:

• product name, description, and image
• the appropriate subgroup for the product
• quantity per pack
• details of the product’s Australian Register of Therapeutic Goods certificate (if applicable)
• clinical information, such as patient needs and benefits over other products
• evidence of clinical efficacy
• details about adverse events
• research papers, if relevant
• pricing information
• predicted use.    

Once completed, mail:

3 samples of your product to:

Stoma Product Assessment Panel (SPAP) Secretariat
Department of Health and Aged Care
PO Box 9848
CANBERRA ACT 2601

Then email an electronic version of your application to stoma@health.gov.au, including:

• the completed and signed application form
• any additional product information or justification
• a photo or image of your product.

The application will be reviewed by the Stoma Product Assessment Panel at its next meeting.

Read more about the application process in the Application and Assessment Guidelines.

Product pricing

The panel advises on appropriate pricing after assessing how the product compares to a benchmark product.

The price set for each product is based on this advice.

Category groups

The schedule categorises like-products into 11 groups, and then further classifies them into 38 subgroups according to their distinct features.

There are separate application forms for suppliers seeking products in:

• Benchmark Listings in Groups 1 to 7
• Listings in Groups 8 to 11 and Price Premium products.

For more information refer to the Application and Assessment Guidelines.

Group summary 

Changing or deleting products from the schedule

Suppliers can apply to:

• change a listing on the schedule –
  • if a variation will affect a product’s classification, pricing, maximum quantity or composition, the application will be assessed by the Panel. Suppliers should apply using the application form for new products.
  • if a variation is administrative in nature (e.g. change of product code or name, or add an additional size of a product), suppliers should apply using an application to amend a listing form. Most administrative variations will be assessed by the secretariat.
• remove a product from the schedule – providing at least 6 months’ notice before removing the product to enable:
  • stoma associations to manage their stock
  • ostomates to find another suitable product.

A product may be removed from the Stoma Appliance Scheme Schedule if:

• it has not been used under the scheme for 2 years
• the Australian Government agrees to a Panel recommendation to delete the product – this could follow an application from the supplier or from a Panel decision based on other information.

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