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