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Regulatory and procedural guidelines (human and veterinary)
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Last updated 1 day ago
Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)
1 day ago
Rules of procedure for the Patients and Consumers Working Party (PCWP) and...
Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2025/2026
2 days ago
Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU...
Procedural guidance to scientific committeesꞌ members and experts on completing the European Medicines Agencyꞌs declaration of interests in the Experts Management Tool
3 days ago
Procedural guidance to scientific committeesꞌ members and experts on completing the European...
European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008
9 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
about 1 month 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
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)