S.L. 458.43 Art. 12Suspension of the trial or infringements.

(1) Where the Licensing Authority has objective grounds for considering that the conditions in the request for authorisation referred to in regulation 9(2) are no longer met or has information raising doubts about the safety or scientific validity of the clinical trial, it may suspend or prohibit the clinical trial and shall notify the sponsor thereof. Before the Licensing Authority reaches its decision it shall, except where there is imminent risk, ask the sponsor and, or the investigator for their opinion, to be delivered within one week. The Licensing Authority shall forthwith inform the other competent authorities, the Ethics Committee concerned, the Agency and the Commission of its decision to suspend or prohibit the trial and of the reasons for the decision.

(2) Where the Licensing Authority has objective grounds for considering that the sponsor or the investigator or any other person involved in the conduct of the trial no longer meets the obligations laid down, it shall forthwith inform him thereof, indicating the course of action which he must take to remedy this state of affairs. The Licensing Authority shall forthwith inform the Ethics Committee, the other competent authorities and the Commission of this course of action.