##  [Black Triangle Scheme Information for Sponsors](/index%2ephp/mandate/black-triangle-scheme-information-for-sponsors) 

Prescription medicines are included in the Black Triangle Scheme if they meet one or more of the following criteria:

1. 1. The product is newly registered (Type A applications, excluding biosimilar medicines and seasonal influenza vaccines)
2. 2. The product is provisionally registered, or has a provisionally registered indication
3. 3. The indications of the product have changed to include use in a significantly different:
4. 4. Population, for example pediatric use
5. 5. Disease or condition, for example a change from an oncology indication to a nononcologic indication

As a sponsor, you may indicate in your application that you expect your product to be included in the scheme



[Consult Now](/webform/consult%0A?url=https://preprod.freyrsolutions.com/index%2ephp/markdownify/node/13914)



Source

[https://www.tga.gov.au/safety/adverse-events/medicine-adverse-events/obligation…](https://www.tga.gov.au/safety/adverse-events/medicine-adverse-events/obligations-report-adverse-events-medicines-and-biologicals/black-triangle-scheme)

 

 

Select Mandate HA

[TGA](/index%2ephp/mandate-by-ha/tga)

 

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[Regulatory Affairs](/index%2ephp/mandate-by-function/regulatory-affairs)