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Regulatory and procedural guidelines (human and veterinary)
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Last updated 5 days ago
Procedure for the preparation of European Union herbal monographs and European Union list entries and appointment of HMPC rapporteurs and peer-reviewers
5 days ago
Procedure for the preparation of European Union herbal monographs and European Union...
IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants
10 days ago
IRIS guide for applicants - How to create and submit scientific applications...
Good practice guidance for communication to the public on medicines’ availability issues
about 1 month 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
about 1 month 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)
about 1 month 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
about 1 month 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
about 1 month 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
about 1 month 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
about 1 month 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)
about 1 month ago
European Medicines Agency procedural advice for users of the centralised procedure for...
Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products
about 1 month 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
about 1 month ago
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO)...