Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)

  1. EudraVigilance registration manual

    EudraVigilance registration manual

  2. EudraVigilance release notes v.1.22

    EudraVigilance release notes v.1.22

  3. EudraVigilance registration documents for Production

    EudraVigilance registration documents for Production

  4. European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes

    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

    European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes