What if sponsors have applied for different terms of approval in Australia and New Zealand for the same product?
In the past, sponsors may have made application to both the TGA and Medsafe for approval of a certain medicine. These applications may have differed in certain areas resulting in different terms of approval. For example additional indications may have been applied for in one or other country, and approved, resulting in different approved indications for the same product in each country. Where there are differences in the terms of the approvals in Australia and New Zealand, to gain a full Agency product licence, the sponsor will need to declare whether or not any aspects of an application have ever been rejected in either country and if so provide details. Additionally details of the date of approval, including copies of relevant documents will need to be supplied to the Agency. The sponsor will need to state clearly what terms are being requested for the full Agency product licence and provide copies of the most recently approved PI/CMI for both countries, a copy of the proposed Agency
Related Questions
- Suprelorin® has been on sale in Australia since December 2004 - is the product in the process of obtaining US and EU approval?
- What if sponsors have applied for different terms of approval in Australia and New Zealand for the same product?
- Could a company apply for the ANZTPA product licence in either Australia or New Zealand?
