List of medicines under additional monitoring
In accordance with the Law on Medicines , the Institute for Medicines and Medical Devices (CInMED) publishes the List of medicines under additional monitoring, formed by the European Medicines Agency (EMA). Medicines whose safety is additionally monitored are labelled by a black inverted triangle.This medicine is under additional monitoring. This label is accompanied by the explanation in the Summary of product characteristics and Package Leaflet.
Label that the medicine is under additional monitoring does not mean that the medicine is not safe to use, but that it is of special importance that healthcare professionals and patients report any suspected adverse reactions to these medicines, in order to speed up the collection of information on their safe use.
In accordance with EU regulations, medicines from the EMA List of medicines under additional monitoring are listed as follows:
- medicines that contain a new active substance authorised in the EU after 1 January 2011;
- biological medicines authorised after 1 January 2011 – this applies to all biological medicines including biosimilars;
- medicines for which the marketing authorisation holder is required to carry out a post-authorisation safety study (PASS);
- medicines given conditional approval, or authorised under exceptional circumstances and medicines authorised with specific obligations on the monitoring and reporting of suspected adverse reactions to medicines.
The list of medicines under additional monitoring is updated once a month by EMA and is available here. CInMED may order additional monitoring for medicines that are authorised in Montenegro and are not on the EMA List.