This update is to communicate a new version of the Regulatory guidance has been published at the following link: Notifying a change of marketing status | European Medicines Agency (europa.eu)
Main updates include:
- A new feature has been implemented in IRIS to allow reporting of products/presentations that have never been in the market. A new Marketing Status option 'Never marketed' has been included. When choosing this option, the rest of the fields (Date of marketing status change, Reason for cessation and Does the cessation leads to shortages) are not mandatory and can be left blank. This can be used in both single and bulk notifications. Newly authorised products will be displayed in IRIS as Never marketed by default.
- Clarification on the reporting of shortages
- Clarification on the reporting of ROW withdrawals
