For this purpose, you will need the new MORE access, which will allow you to utilize MORE forms such as XML reports and manually submit web forms within the MORE Portal. These include:
- Manufacturer Incident Report (MIR)
- Field Safety Corrective Actions (FSCAs)
- Trend Reports
- Periodic Summary Reports (PSRs)
- New form for reporting Serious Adverse Events (SAEs) in clinical studies
If you require assistance with reporting or implementing the new requirements for the UK in your company, please feel free to reach out to us at any time.