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Regulatory and procedural guidelines (human and veterinary)
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Latest posts
Last updated 6 days ago
Questions and answers on Article 20 non-pharmacovigilance procedures
6 days ago
Questions and answers on Article 20 non-pharmacovigilance procedures
Questions and answers on Article 13 referral procedures
6 days ago
Questions and answers on Article 13 referral procedures
Questions and answers on Article 29(4) referral procedures
6 days ago
Questions and answers on Article 29(4) referral procedures
Questions and answers on Article 30 referral procedures
7 days ago
Questions and answers on Article 30 referral procedures
Questions and answers on Article 31 non-pharmacovigilance referrals
7 days ago
Questions and answers on Article 31 non-pharmacovigilance referrals
Pre-notification check for type IB Variations
9 days ago
Pre-notification check for type IB Variations
Qualification of novel methodologies for medicinal product development: guidance to applicants
15 days ago
Qualification of novel methodologies for medicinal product development: guidance to applicants
Committee for Advanced Therapies (CAT) rules of procedure
about 1 month 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
about 2 months 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
about 2 months 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
about 2 months 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
2 months ago
Questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document...