Marketing authorization holders are hereby informed that the following have been published on the CInMED portal, under Human Medicines / Placing a medicine on the market / Instructions and Forms:
- Manner of submitting application and documentation for notifications(under Instructions), and
- the Notification Form in accordance with Article 68 of the Law on Medicines (under Forms).
All stakeholders are kindly requested to follow the published Guideline and use the Notification Form when submitting notifications.