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Regulatory and procedural guidelines (human and veterinary)
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Last updated 4 days ago
Committee for Advanced Therapies (CAT) rules of procedure
4 days ago
Committee for Advanced Therapies (CAT) rules of procedure
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 3
23 days ago
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO)...
Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2026/2027
25 days ago
Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting...
Second amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2026/2027
25 days ago
Second amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza...
Questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document for assessors
29 days ago
Questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document...
Notice to sponsors on validation and qualification of computerised systems used in clinical trials
about 2 months ago
Notice to sponsors on validation and qualification of computerised systems used in...
Tables of non-standard abbreviations to be used in the summary of product characteristics
3 months ago
Tables of non-standard abbreviations to be used in the summary of product...
Names of the European Union / European Economic Area countries
3 months ago
Names of the European Union / European Economic Area countries
Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products
3 months ago
Mobile scanning and other technologies in the labelling and/or package leaflet of...
Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products
4 months ago
Question and answer on the information contained within section 5.1 of the...
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026
4 months ago
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026
Guidance for applicants for the preparation of the precise scope section of the variation application form
4 months ago
Guidance for applicants for the preparation of the precise scope section of...