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

    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

    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

    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

    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

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