CRED Managing Variations Effectively

EU Falsified Medicines Legislation: implementation of safety features The Update of the Annex IIIA does not imply that the safety features have already been implemented but that the MAH intends to implement them by 9 th Feb 2019 in compliance with the falsified medicines legislation. New medicines authorised since April 2016 already contain updated Annex III. MAHs for authorised medicines can update their Annex IIIA: •First regulatory procedure affecting the annexes (e.g. Renewal, Line Extension, Variation). •Article 61(3) Notification within 3 years, in case of no regulatory procedure. •If ATD is placed on the immediate packaging, if there is no outer packaging and the ATD affects the container and its closure system(s), applicants are required to submit the appropriate variations (section B.II.e of the Variation Guidelines) •Same approach for inclusion of the information or removal if the product no longer needs the safety features.