Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)
  1. Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
  2. IRIS guide to registration and RPIs
  3. List of centrally authorised products requiring a notification of a change for update of annexes
  4. Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation Guide
  5. Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7