Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)
  1. List of centrally authorised products requiring a notification of a change for update of annexes
  2. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
  3. European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
  4. European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
  5. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure