Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)
  1. EudraVigilance registration manual
  2. EudraVigilance release notes v.1.22
  3. EudraVigilance registration documents for Production
  4. European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
  5. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes