Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Article 62 Application for variations requiring assessment

1. Where a variation is not included in the list established in accordance with Article 60(1), the marketing authorisation holder shall submit an application for a variation requiring assessment to the competent authority which has granted the marketing authorisation or to the Agency, as applicable. The applications shall be submitted electronically.

2. The application referred to in paragraph 1 shall contain:

(a) a description of the variation;

(b) data referred to in Article 8 relevant to the variation;

(c) details of the marketing authorisations affected by the application;

(d) where the variation leads to consequential variations to the terms of the same marketing authorisation, a description of those consequential variations;

(e) where the variation concerns marketing authorisations granted under the mutual recognition or decentralised procedures, a list of Member States which granted those marketing authorisations.