Black Triangle Scheme - information for sponsors


11 January 2018 - The eligibility of a product for inclusion in the scheme will be considered in the Risk Management Plan evaluation.

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

  • The product is newly registered (Type A applications, excluding biosimilar medicines and seasonal influenza vaccines)
  • The product is provisionally registered, or has a provisionally registered indication
  • The indications of the product have changed to include use in a significantly different patient population or disease/condition

Fully-registered products that meet the eligibility criteria are included in the Scheme for a 5 year period. The duration of inclusion starts from the date of first supply for new medicines, or the date of entry into the ARTG for new indications. Sponsors are reminded of the requirement to inform TGA of the date of first supply, as stated in the conditions of registration.

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Michael Wonder

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Michael Wonder