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Regulatory and procedural guidelines (human and veterinary)
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Last updated 4 days ago
Good practice guidance for communication to the public on medicines’ availability issues
4 days ago
Good practice guidance for communication to the public on medicines’ availability issues
Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics - Revision 1
4 days ago
Guidance on the procedural aspects for the consultation to the European Medicines...
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)
4 days ago
EMA procedural advice for medicinal products intended exclusively for markets outside the...
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
4 days ago
EMA recommendation on the procedural aspects and dossier requirements for the consultation...
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications: document with track changes
5 days ago
European Medicines Agency procedural advice for users of the centralised procedure for...
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications
5 days ago
European Medicines Agency procedural advice for users of the centralised procedure for...
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications
5 days ago
European Medicines Agency procedural advice for users of the centralised procedure for...
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes)
5 days ago
European Medicines Agency procedural advice for users of the centralised procedure for...
Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products
5 days ago
Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2
4 days ago
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO)...
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes
6 days ago
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance...
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements
10 days ago
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO)...