We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
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 |