Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)

  1. Validation checklist for Type II quality variations

    Validation checklist for Type II quality variations

  2. Procedural advice for veterinary vaccine antigen master file (VAMF) certification

    Procedural advice for veterinary vaccine antigen master file (VAMF) certification

  3. Plasma Master File (PMF) requirements - questions and answers for PMF holders

    Plasma Master File (PMF) requirements - questions and answers for PMF holders

  4. Recommended submission dates for veterinary medicinal products

    Recommended submission dates for veterinary medicinal products

  5. Validation checklist for Type II (non) clinical variations

    Validation checklist for Type II (non) clinical variations