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. 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

  3. IRIS guide to registration and RPIs

    IRIS guide to registration and RPIs

  4. EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information

    EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information

  5. Good practices for industry for the prevention of human medicinal product shortages

    Good practices for industry for the prevention of human medicinal product shortages