Marketing authorisations (MA) granted in the Community initially last for 5 years according to Regulation 19(1) of the Marketing Authorisations Regulations (Article 24(1) of Directive 2001/83/EC , as amended). After 5 years, the MA will need to be renewed on the basis of a reassessment of the risk-benefit balance.
Legislation
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-2_en
Information
Information on Renewal of Marketing Authorization for Products.
Application
Application form for Renewal of Marketing Authorization for Products.
Competent Authority
Medicines Authority
last updated June 2026