Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)

  1. 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

  2. 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

  3. Public consultation concerning the physical attendance and the location of personal residency of the qualified person

    Public consultation concerning the physical attendance and the location of personal residency of the qualified person

  4. Recommended submission dates for veterinary medicinal products

    Recommended submission dates for veterinary medicinal products

  5. Annex VII to procedure for conducting GCP inspections requested by the CHMP: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials

    Annex VII to procedure for conducting GCP inspections requested by the CHMP: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials