CHAPTER IGENERAL PROVISIONS
Article 5Information requirements
An application submitted in accordance with Article 50(2) of Regulation (EU) No 528/2012 shall contain the following:
- (1)
the relevant filled application form F1..., which shall contain:
- (2)
a description of all the changes sought;
- (3)
where a change leads to or is the consequence of other changes of the terms of the same authorisation, a description of the relation between these changes;
- (4)
all relevant supporting documents to demonstrate that the proposed change would not adversely affect the conclusions previously reached concerning the compliance with the conditions set out in Article 19 or 25 of Regulation (EU) No 528/2012; F6, including any further information requested by the competent authority.
- (5)
F7...