7. Types of Marketing Authorisation Applications

Marketing authorisations for medicines are dynamic and not static, and the dossier underlying a marketing authorisation must be regularly updated. This ensures that scientific progress and new regulatory requirements are respected, in accordance with Article 23 of Directive 2001/83/EC, Annex I to Directive 2001/83/EC and Article 16 of Regulation (EC) No 726/2004.

Specifically, any information which may influence the evaluation of the benefits and the risks of the medicine must be promptly supplied. In this regard, marketing authorisation holders of marketing authorisations granted in accordance with Article 10 or 10c of Directive 2001/83/EC should implement variations swiftly whenever the marketing authorisation of the reference medicine is changed to address a safety or efficacy concern. In addition, the marketing authorisation holder should inform the competent authorities relating to any pharmacovigilance concerns according to Article 104 of Directive 2001/83/EC.