S.L. 427.10 Art. 11Notified bodies.

(1) The Medicines Authority shall notify the Commission and other Member States of the bodies which it has designated for carrying out the tasks pertaining to the procedures referred to in regulation 6(1) to (9) together with the specific tasks for which the bodies have been designated.

(2) The Medicines Authority shall apply the criteria set out in Schedule VIII for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards shall be presumed to meet the relevant criteria.

(3) The Medicines Authority shall withdraw the notification if it finds that the body no longer meets the criteria referred to in sub-regulation (2). It shall immediately inform the other Member States and the Commission thereof.

(4) The notified body and the manufacturer, or his authorised representative, shall lay down, by common accord, the time limits for completion of the evaluation and verification operations referred to in Schedules II to V.

(5) The notified body shall inform the Medicines Authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of these regulations about certificates suspended, withdrawn or refused and, on request, about certificates issued: Provided that, the notified body shall also make available, on request, all additional relevant information.

(6) (a) Where a notified body finds that pertinent requirements of these regulations have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.

(b) In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform the Medicines Authority thereof. The Medicines Authority shall inform the other Member States and the Commission.

(7) The notified body shall, on request, supply all relevant information and documents including budgetary documents, required to enable the Medicines Authority to verify compliance with the criteria laid down in Schedule VIII.