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Regulatory and procedural guidelines (human and veterinary)
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Last updated about 21 hours ago
Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans - Rev.18
26 days ago
Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities...
Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products - Rev.17
26 days ago
Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms...
List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products
26 days ago
List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA)...
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 - tracked changes
7 days ago
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO)...
Guidance for industry on implementing Shortage Prevention Plans (SPP)
12 days ago
Guidance for industry on implementing Shortage Prevention Plans (SPP)
Questions and answers on Article 20 non-pharmacovigilance procedures
about 1 month ago
Questions and answers on Article 20 non-pharmacovigilance procedures
Questions and answers on Article 13 referral procedures
about 1 month ago
Questions and answers on Article 13 referral procedures
Questions and answers on Article 29(4) referral procedures
about 1 month ago
Questions and answers on Article 29(4) referral procedures
Questions and answers on Article 30 referral procedures
about 1 month ago
Questions and answers on Article 30 referral procedures
Questions and answers on Article 31 non-pharmacovigilance referrals
about 1 month ago
Questions and answers on Article 31 non-pharmacovigilance referrals
Pre-notification check for type IB Variations
about 1 month ago
Pre-notification check for type IB Variations
Qualification of novel methodologies for medicinal product development: guidance to applicants
about 1 month ago
Qualification of novel methodologies for medicinal product development: guidance to applicants