![]() European regulatory authorities closely monitor this information to make sure that the benefits of medicines continue to outweigh their risks. Information is continuously collected after a medicine is placed on the market to monitor real-life experience with the product. It is therefore vital that the safety of all medicines continues to be monitored while they are in commercial use. Some less common side effects may only occur once a medicine has been used for a long time by a large number of people. They may have other diseases and they may be taking other medicines. In a real-life setting, a larger and more diverse group of patients will use the medicine. Patients in clinical trials are carefully selected and followed up very closely under controlled conditions. This ensures that patients can access the treatments they need without being exposed to unacceptable side effects.Ĭlinical trials involve a relatively small number of patients for a limited period of time. Only medicines whose benefits have been shown to be greater than their risks can reach the market. Other medicines can also be placed under additional monitoring, based on advice from the Agency's Pharmacovigilance Risk Assessment Committee ( PRAC).Įuropean regulatory authorities decide to authorise medicines after assessing their benefits and risks based on the results of clinical trials. it is authorised with specific obligations on the recording of suspected adverse drug reactions.the company that markets the medicine is required to carry out additional studies, for instance, to provide more data on long-term use of the medicine or on a rare side effect seen during clinical trials.it has been given a conditional approval (where the company that markets the medicine must provide more data about it) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data).it is a biological medicine, such as a vaccine or a medicine derived from plasma (blood), authorised in the EU after 1 January 2011.it contains a new active substance authorised in the EU after 1 January 2011.The black triangle started appearing in the package leaflets of the medicines concerned from the autumn of 2013.Īdditional monitoring status is always applied to a medicine in the following cases: The concept of additional monitoring was introduced by the 2010 pharmacovigilance legislation, which came into effect in July 2012. The symbol does not appear on the outer packaging or labelling of medicines.Īdditional monitoring aims to enhance reporting of suspected adverse drug reactionsfor medicines for which the clinical evidence base is less well developed. The main goals are to collect information as early as possible to further inform the safe and effective use of these medicines and their benefit-risk profile when used in everyday medical practice. This medicinal product is subject to additional monitoring. Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and in the information for healthcare professionals called the summary of product characteristics, together with a short sentence explaining what the triangle means: In the European Union (EU), medicines that are being monitored particularly closely by regulatory authorities are labelled with a black inverted triangle (▼ ) in the product information. These medicines are described as being under 'additional monitoring'. The European Medicines Agency (EMA) maintains a list of all medicines that are under additional monitoring in the EU. Submitting a post-authorisation application.Post-authorisation efficacy studies (PAES).List of medicines under additional monitoring.Direct healthcare professional communications.Changing the labelling and package leaflet (Article 61(3) notifications).Changing the (invented) name of a medicinal product.
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