What action can a report lead to?
- Published: January 19, 2021
- Last updated: August 17, 2022
Individual reports of suspected adverse events seldom lead to any regulatory action being taken, but when a number of reports form the foundation of a signal, regulatory action can be considered.
The measures taken vary depending on the context in which the suspected adverse events occur, their severity and the description in the current product information (SPC).
Examples of possible measures include:
- Updating warnings on the packaging, package leaflet or SPC
- Amending the indication of a medicinal product
- Suspension or withdrawal of a marketing authorisation.