2017/745_AnnexI  _ II_III_ IV_ V_ VI_ VII_ VIII_IX_X_XI_XII_XIII_XIV_XV_XVI_XVII

Article 76
Corrective measures to be taken by Member States and information exchange between Member States


1.   Where a Member State in which a clinical investigation is being or is to be conducted has grounds for considering that the requirements set out in this Regulation are not met, it may take at least any of the following measures on its territory:

(a)

revoke the authorisation for the clinical investigation;

(b)

suspend or terminate the clinical investigation;

(c)

require the sponsor to modify any aspect of the clinical investigation.

2.   Before the Member State concerned takes any of the measures referred to in paragraph 1 it shall, except where immediate action is required, ask the sponsor or the investigator or both for their opinion. That opinion shall be delivered within seven days.

3.   Where a Member State has taken a measure referred to in paragraph 1 of this Article or has refused a clinical investigation, or has been notified by the sponsor of the early termination of a clinical investigation on safety grounds, that Member State shall communicate the corresponding decision and the grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 73.

4.   Where an application is withdrawn by the sponsor prior to a decision by a Member State, that information shall be made available through the electronic system referred to in Article 73 to all Member States and the Commission.