Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)

  1. 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

  2. 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

  3. 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

  4. 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

  5. Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections

    Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections