S.L. 427.10 Art. 7Clinical investigations.

(1) In the case of devices intended for clinical investigations, the manufacturer or the authorised representative shall, at least sixty days before the commencement of the investigations, submit the statement referred to in Schedule VI to the Medicines Authority and the competent authorities in other Member States in which the investigations are to be conducted.

(2) (a) The manufacturer may commence the relevant clinical investigations at the end of a period of sixty days after notification, unless the Medicines Authority or the Ethics Committee established by the Clinical Trials Regulations have notified him, within that period, of a decision to the contrary, based on considerations of public health or public policy.

(b) However, the Medicines Authority may authorise manufacturers to start the clinical investigations in question before the expiry of the sixty-day period, provided that the Ethics Committee mentioned above has issued a favourable opinion with respect to the investigation programme in question, including its review of the clinical investigation plan.

(3) If necessary, any appropriate steps to ensure public health and public policy shall be taken according to the Public Health Act.

(4) Where a clinical investigation is refused or halted by the Maltese authorities, the Medicines Authority shall communicate such decision and the grounds thereof to all Member States and the Commission. Where the Medicines Authority have called for a significant modification or temporary interruption of a clinical investigation, the Medicines Authority shall inform the Member States concerned about such actions and the grounds for the actions taken.

(5) The manufacturer or his authorised representative shall notify the Medicines Authority and the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission. The manufacturer or his authorised representative shall keep the report referred to in section 2(c)(vii) of Schedule VII at the disposal of the Medicines Authority and the competent authorities of the other Member States concerned.

(6) Clinical investigations shall be conducted in accordance with the provisions of Schedule VII.