Definition of terms

Pharmacovigilance System Master File (PSMF) – a detailed description of the pharmacovigilance system used by the marketing authorization holder with respect to one or more authorized medicinal products

Qualified person for pharmacovigilance – a person nominated by the marketing authorization holder, responsible for the establishment and maintenance of the pharmacovigilance system of the marketing authorisation holder

Contact person for pharmacovigilance issues – a person appointed by the marketing authorization holder, based in the European Union and reporting to the qualified person responsible for pharmacovigilance