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
  2. List of centrally authorised products requiring a notification of a change for update of annexes
  3. 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
  5. Good practices for industry for the prevention of human medicinal product shortages