National contact points for standalone signal notifications.In line with GVP IX requirements, standalone notifications of signals detected in EudraVigilance should be sent to the Agency ( and to the competent authorities in Member States where the medicinal product is authorised using the standalone signal notification form (see also transitional arrangements for MAHs). Guidance on regulatory requirements and on the monitoring and reporting processes for signals is available in good pharmacovigilance practices (GVP) Module IX on signal management. On 22 November 2017, EMA launched the new EudraVigilance system and enabled MAH access to the system. It also requires MAHs to inform EMA and national competent authorities of validated signals detected when monitoring the database.

The evaluation of safety signals is part of routine pharmacovigilance and is essential to ensuring that regulatory authorities have the most up-to-date information on a medicine's benefits and risks.Ĭommission Implementing Regulation (EU) No 520/2012 (article 18) requires EMA, national competent authorities and marketing authorisation holders (MAHs) to continuously monitor the data available in EudraVigilance. The assessment of safety signals establishes whether or not there is a causal relationship between the medicine and the reported adverse event. An illness or another medicine taken by the patient could also be the cause. The presence of a safety signal does not directly mean that a medicine has caused the reported adverse event. The EudraVigilance database is an important source of information on suspected adverse reactions and signals. Safety signals can be detected from a wide range of sources, such as spontaneous reports, clinical studies and scientific literature. The European Medicines Agency (EMA), together with the regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals.

Submitting a post-authorisation applicationĪ safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation.

Post-authorisation efficacy studies (PAES).

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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