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Regulatory and procedural guidelines (human and veterinary)
Get the latest updates from Regulatory and procedural guidelines (human and veterinary) directly as they happen.
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Latest posts
Last updated 20 days ago
Questions and answers on Article 20 non-pharmacovigilance procedures
20 days ago
Questions and answers on Article 20 non-pharmacovigilance procedures
Questions and answers on Article 13 referral procedures
20 days ago
Questions and answers on Article 13 referral procedures
Questions and answers on Article 29(4) referral procedures
20 days ago
Questions and answers on Article 29(4) referral procedures
Questions and answers on Article 30 referral procedures
21 days ago
Questions and answers on Article 30 referral procedures
Questions and answers on Article 31 non-pharmacovigilance referrals
21 days ago
Questions and answers on Article 31 non-pharmacovigilance referrals
Pre-notification check for type IB Variations
23 days ago
Pre-notification check for type IB Variations
Qualification of novel methodologies for medicinal product development: guidance to applicants
29 days ago
Qualification of novel methodologies for medicinal product development: guidance to applicants
Committee for Advanced Therapies (CAT) rules of procedure
about 2 months 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
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
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
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...