Article 77U.K.Corrective measures to be taken by Member States
1.Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a)revoke the authorisation of a clinical trial;
(b)suspend a clinical trial;
(c)require the sponsor to modify any aspect of the clinical trial.
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 and/or the investigator for their opinion. That opinion shall be delivered within seven days.
3.The Member State concerned shall immediately after taking a measure referred to in paragraph 1 inform all Member States concerned through the EU portal.
4.Each Member State concerned may consult the other Member States concerned before taking any of the measures referred to in paragraph 1.