A marketing authorisation holder may implement a variation requiring assessment only after a competent authority or the Commission, as applicable, has amended the decision granting the marketing authorisation in accordance with that variation, has set a time limit for the implementation and has notified the marketing authorisation holder thereof in accordance with Article 67(3).

Where requested by a competent authority or the Commission, a marketing authorisation holder shall supply, without delay, any information related to the implementation of a variation.