Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)
  1. Procedural advice on paediatric applications
  2. Member states contact points for translations review
  3. Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2024
  4. Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7
  5. List of centrally authorised products requiring a notification of a change for update of annexes