The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
This user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines.
Contents
- About this user guide
- Timeframe
- Supplying products with former sponsor details
- Applying for a variation to change sponsor details
- Fees
- Application process
- When PI changes are approved
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | Regulatory Guidance Team | October 2020 |