The Institute for Medicines and Medical Devices (CInMED) reminds marketing authorisation holders of medicinal products for human use of their obligation to conduct and regularly update risk assessments for the presence of nitrosamine impurities, in accordance with Article 63 of the Law on Medicines (“Official Gazette of Montenegro”, Nos. 14/26 and 94/26) and the relevant guidelines of the European Medicines Agency (EMA).

In this regard, all marketing authorisation holders are requested to submit to CInMED, within 90 days of the publication of this notice, information on the status of the risk assessments conducted for all medicinal products for which they hold a valid marketing authorisation in Montenegro, together with the relevant documentation, if such documentation has not been previously submitted or has since been updated.

If the documentation has already been submitted and no new relevant information or changes have arisen, an appropriate confirmation should be provided.

The requested information and documentation should be submitted by email to [email protected].