EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)
Pre-submission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application
EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device - Revision 2
Quarterly system demo - Q4 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 12 December 2024, 09:00 (CET) to 12 December 2024, 12:00 (CET)
Work plan for the Committee for Veterinary Medicinal Products (CVMP) Environmental Risk Assessment Working Party (ERAWP) 2025
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2
Norditropin NordiFlex
Emer Cooke, EMA’s Executive Director: 2024 achievements in medicine regulation
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications: document with track changes