Procedures for centrally authorised medicinal products1
Procedures for nationally authorised medicinal products
- Please note that due to the COVID-19 pandemic, the original, signed paper version of the Commission decision and associated annexes will not be sent to marketing authorisation holders by courier. It will be only sent by e-mail with a request to acknowledge receipt of the documents.
- Please ensure that someone is available to access the contact e-mail address you have supplied to the European Medicines Agency and to send an acknowledgement of receipt of the documents. Please check e-mails regularly if you are expecting to receive a Commission decision.
1 Variation procedures which do not affect the Commission Decision granting the marketing authorisation (including its annexes) are no longer reflected in the Union Register of medicinal products since 1 April 2011.
2 The Register of medicinal products for human use authorised by the EU under the centralised procedure. Published in accordance with Article 13 of Regulation (EC) No 726/2004.
3 The Register of orphan medicinal products for human use designated and published by the EU in accordance with Article 5 of Regulation (EC) N141/2000.
4 The Register of veterinary medicinal products authorised by the EU under the centralised procedure. Published in accordance with Article 38 of Regulation (EE) 726/2004.
5 The list of Exceptional Marketing Authorisations is published in accordance with Article 126a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use.