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.

The provision of advice from the Paul-Ehrlich-Institut or other institutions such as the European Medicines Agency on the appropriate tests and studies required in the development or the quality of a medicine.

Serious side effects are side effects that are fatal or life-threatening, require inpatient treatment or prolongation of inpatient treatment, lead to permanent or serious disability, invalidity, congenital abnormalities, or birth defects (section 4 subsection 13 sentence 2 of the AMG).

Suspected cases of serious side effects must be reported by the marketing authorisation holder within a short timeframe to the EudraVigilance system, the European side effect database (section 63c subsection 2 sentence 1 no. 2 of the AMG).

Side effects of a drug are harmful and unintended reactions to the drug. It does not matter if the side effect is due to proper use - i.e. in accordance with the instructions in the package leaflet or Special Information - or if it has occurred with overdose, medication error, misuse, misuse or occupational exposure.

Summary Of Product Characteristics (SPC or SmPC): A document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively.

A medicine containing cells or tissues which have been manipulated to change their biological characteristics, and which is used to cure, diagnose or prevent a disease.

The spontaneous reporting system is one of the most important tools for the early detection of suspected side effects in the area of post-authorisation medicinal product safety. There may be valuable indications (signals) of rare, hitherto unknown side effects, of an increase in the frequency of known side effects, of increase frequency of certain side effects caused by quality defects, or of changes in the nature or severity of known side effects. Reports of adverse drug reactions (ADRs) are recorded in the spontaneous reporting system. The reports are “spontaneously” documented and reported outside of systematic examinations. The spontaneous reporting system is a passive reporting system insofar as vaccinees are not actively addressed regarding any adverse reactions, but instead have the option of reporting suspected side effects themselves or via their doctor or the pharmacy in which they were vaccinated. A legal obligation to report exists for doctors, lead pharmacists in pharmacies where vaccination is carried out, and the pharmaceutical company that holds the marketing authorisation. The legal basis for the spontaneous reporting system is provided by sections 62 and 63 of the German Medicinal Products Act (Arzneimittelgesetz, AMG).

A legal provision stating that the marketing authorisation of a medicine will cease to be valid if the medicine is not placed on the market within three years of the authorisation being granted or if the medicine is removed from the market for three consecutive years.

SUSAR stands for Suspected Unexpected Serious Adverse Reactions. This refers to suspected cases of unexpected serious adverse reactions observed in clinical trial participants. SUSAR does not refer to the side effects of already authorised medicinal products but only to the suspicion of an unexpected serious adverse reaction associated with the administration of a medicinal product or active substance in the clinical trial.

Suspected cases of vaccine adverse events are reports of medical events that occurred in temporal proximity to a vaccination and cannot be directly attributed to other causes.