CHAPTER XIII

SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS

Union controls
Article 79
1
The Commission may conduct controls in order to verify:
a
whether Member States correctly supervise compliance with this Regulation;
b
whether the regulatory system applicable to clinical trials conducted outside the Union ensures that point 8 of the Introduction and general principles contained in Annex I to Directive 2001/83/EC is complied with;
c
whether the regulatory system applicable to clinical trials conducted outside the Union ensures that Article 25(5) of this Regulation is complied with.
2
The Union controls referred to in point (a) of paragraph 1 shall be organised in cooperation with the Member States concerned.
The Commission shall prepare in cooperation with the Member States a programme for the Union controls referred to in points (b) and (c) of paragraph 1.
The Commission shall report on the findings of each Union control carried out. Those reports shall, if appropriate, contain recommendations. The Commission shall submit those reports through the EU portal.