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Regulatory and procedural guidelines (human and veterinary)
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Last updated 13 days ago
Guidance and template for industry on implementing Shortage Prevention Plans (SPP)
13 days ago
Guidance and template for industry on implementing Shortage Prevention Plans (SPP)
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
about 1 month 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
about 1 month 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
about 1 month 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
21 days ago
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO)...
Guidance for industry on implementing Shortage Prevention Plans (SPP)
26 days ago
Guidance for industry on implementing Shortage Prevention Plans (SPP)
Questions and answers on Article 20 non-pharmacovigilance procedures
about 2 months ago
Questions and answers on Article 20 non-pharmacovigilance procedures
Questions and answers on Article 13 referral procedures
about 2 months ago
Questions and answers on Article 13 referral procedures
Questions and answers on Article 29(4) referral procedures
about 2 months ago
Questions and answers on Article 29(4) referral procedures
Questions and answers on Article 30 referral procedures
about 2 months ago
Questions and answers on Article 30 referral procedures
Questions and answers on Article 31 non-pharmacovigilance referrals
about 2 months ago
Questions and answers on Article 31 non-pharmacovigilance referrals
Pre-notification check for type IB Variations
about 2 months ago
Pre-notification check for type IB Variations