Medicinal products subjected to additional monitoring
The European Union (EU) has introduced an identifier for medicinal products under particularly close monitoring. A black triangle has been added to the package leaflet of these medicinal products accompanied by the following text:
“This medicinal product is under additional monitoring”
Medicinal products with a black triangle added to their summary of product characteristics and package leaflet are subjected to additional monitoring. It does not mean that this medicinal product is not safe. The medicinal products available on the legal market in the European Union (including Latvia) are closely monitored. Medicinal products with a black triangle in the product information are monitored even more closely. It is mostly related to the fact that there is less information available about these medicinal products than about others, for example, medicinal products just released on the market or with insufficient data regarding the effects of the product during long-term use.
When is additional monitoring applied?
- For medicinal product containing a new active substance that was authorised in the European Union after 1 January 2011;
- For biological medicinal products, for example, vaccines or medicinal products derived from blood plasma, authorised in the European Union after 1 January 2011;
- For medicinal products with a conditional marketing authorisation (marketing authorisation holders (MAHs) must submit additional data in the post-authorisation period) or medicinal products authorised in exceptional circumstances (certain reasons exist why the MAH cannot submit a wide range of required data);
- MAH must conduct additional studies, for example, in order to provide additional data regarding long-term use of medicinal product or rare adverse reactions observed during clinical trials.
Additional monitoring may be applied also in other cases in accordance with recommendations issued by the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC).
List of medicinal products under additional monitoring