An evaluation conducted by a European Medicines Agency committee following a referral from the European Commission or a Member State. Referrals are used to address particular issues, such as safety concerns.

Safety signals or risk signals contain new information concerning the safety of an authorised medicinal product, such as previously unknown adverse events following the administration of a medicinal product or new aspects of already known events requiring further investigation. Signals are generated from various sources, such as the analysis of spontaneously reported suspected side effects, clinical trials, or scientific literature.

According to Section 4 Subsection 36 of the German Medicinal Products Act (Arzneimittelgesetz, AMG), a risk management system comprises activities in the field of pharmacovigilance and measures that are intended to identify, characterise, avoid or minimize risks associated with a medicinal product, including an assessment of the effectiveness of such activities and measures. The risk management system is an obligatory part of the authorisation process for a medicinal product

The Robert-Koch-Institut (RKI) is the federal government's central public health organisation for the detection, prevention and control of disease and the national public health institute. It assesses, analyses and researches diseases of high risk, wide distribution, or of great public or health significance.

A risk management plan is a detailed description of the risk management system and thus an integral part of the marketing authorisation documents to be submitted by the medicinal product developer. The risk management plan ensures that a structured planning of risk minimisation measures and additional analyses already exists at the time of authorisation. The measures are updated throughout the 'life cycle' of a medicinal product.

The European Union Member State that leads the review of an application in a mutual recognition procedure or decentralised procedure.