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Regulatory and procedural guidelines (human and veterinary)
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Last updated 11 days ago
Amended 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
11 days ago
Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting...
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes
16 days ago
European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance...
Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)
18 days 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
19 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
19 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
26 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 2 months 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 2 months 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 2 months 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 2 months ago
Substances considered as not falling within the scope of Regulation (EC) No...
Guidance on Irish language derogation ending on 1 January 2022
3 months ago
Guidance on Irish language derogation ending on 1 January 2022