Glossary

A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility.

Adapted from the Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 3) 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500143294.pdf