The European Union has introduced a new labelling system for medicines that are subject to particularly close monitoring.
In the product infomrmation, these medicinal products are identified by a black inverted triangle (▼) and the following information is given:
Summary of Product Characteristics:
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Please be assured that “Additional monitoring" does not mean that the drug is unsafe.
Before a medicinal product is placed on the market, the efficacy and safety of the medicinal product must be demonstrated by clinical studies and laboratory tests. Only medicinal products for which it has been demonstrated that their benefits outweigh their risks are authorised by the authority and placed on the market.
All medicinal products on the market are carefully monitored. For example, less frequent adverse reactions are only observed if a medicinal product is used under real-life conditions by a large number of different people over a long period of time.
“Additional surveillance" has been introduced to strengthen the surveillance of certain medicinal products (as listed below) and in particular to encourage spontaneous reporting of adverse reactions. The aim is to collect additional information as early as possible in order to further establish the risk profile of medicinal products in clinical practice and thus provide information on safe and effective use.
Particularly close monitoring is foreseen for medicinal products for which less information is available than for other medicinal products, for example because they are new to the market. Medicinal products under additional supervision also include those for which the medicines authorities require further studies, e.g. for long-term use.
In principle, additional monitoring is carried out in the following cases:
- if the medicinal product contains a new active substance approved in the EU after 1 January 2011;
- in the case of a biological medicinal product such as a vaccine or a medicinal product derived from plasma (blood) authorised in the EU after 1 January 2011;
- if the medicinal product has received a conditional marketing authorisation (the company placing the medicinal product on the market must provide further data on it) or a marketing authorisation in exceptional circumstances (there are specific reasons why the company cannot provide comprehensive data);
- if the company placing the medicinal product on the market has to carry out further studies, for example to provide further data on the long-term use of the medicinal product or on a rare adverse reaction observed during clinical trials.
Other medicinal products may also be put under additional surveillance following a recommendation from the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency.
A list of all medicinal products under additional supervision is published on the website of the European Medicines Agency (EMA).