CHAPTER VII

SAFETY REPORTING IN THE CONTEXT OF A CLINICAL TRIAL

Assessment by Member States
Article 44
1
The Agency shall, by electronic means, forward to the Member States concerned the information reported in accordance with Article 42 and 43.
2
Member States shall cooperate in assessing the information reported in accordance with Articles 42and 43. The Commission may, by means of implementing acts, set up and modify the rules on such cooperation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(2).
3
The responsible ethics committee shall be involved in the assessment of the information referred to in paragraphs 1 and 2, if it has been provided for in the law of the Member State concerned.