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Regulatory and procedural guidelines (human and veterinary)
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Last updated 4 days ago
European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008
4 days ago
European Medicines Agency procedural advice on recommendations on unforeseen variations according to...
Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004
29 days ago
Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in...
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products 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 similar biological medicinal products applications: document with track changes
about 1 month ago
European Medicines Agency procedural advice for users of the centralised procedure for...
Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
about 1 month ago
Substances considered as not falling within the scope of Regulation (EC) No...
Guidance on Irish language derogation ending on 1 January 2022
about 2 months 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
2 months ago
EU Implementation Guide (IG) on veterinary medicines product data in the Union...
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
2 months ago
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
European Medicines Agency Write PMS API implementation Guide (zip)
2 months ago
European Medicines Agency Write PMS API implementation Guide (zip)
European Medicines Agency Write PMS API implementation Guide
2 months 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
2 months 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
3 months ago
IRIS guide for applicants - How to create and submit scientific applications...