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Regulatory and procedural guidelines (human and veterinary)
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Last updated 5 days ago
Guidance on Irish language derogation ending on 1 January 2022
5 days ago
Guidance on Irish language derogation ending on 1 January 2022
EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Technical specifications
9 days ago
EU Implementation Guide (IG) on veterinary medicines product data in the Union...
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
14 days ago
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
European Medicines Agency Write PMS API implementation Guide (zip)
15 days ago
European Medicines Agency Write PMS API implementation Guide (zip)
European Medicines Agency Write PMS API implementation Guide
15 days ago
European Medicines Agency Write PMS API implementation Guide
Procedure for the preparation of European Union herbal monographs and European Union list entries and appointment of HMPC rapporteurs and peer-reviewers
23 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
28 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 2 months 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 2 months 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 2 months 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 2 months 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 2 months ago
European Medicines Agency procedural advice for users of the centralised procedure for...