Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)

  1. European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008

    European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008

  2. 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

  3. 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

  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 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