Regulatory & Procedural Guidelines

Regulatory and procedural guidelines (human and veterinary)

  1. Member states contact points for translations review

    Member states contact points for translations review

  2. Guidance on parallel EMA / EUnetHTA 21 Joint Scientific Consultation

    Guidance on parallel EMA / EUnetHTA 21 Joint Scientific Consultation

  3. IRIS guide for parallel distribution applicants

    IRIS guide for parallel distribution applicants

  4. Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure

    Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure

  5. 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