S.L. 483.4 Art. 8Inspections, etc., by Licensing Authority.

(1) The Licensing Authority shall organise inspections and carry out control measures as appropriate whenever there is any serious adverse reaction or serious adverse event. In addition, such an inspection shall be organised and control measures shall be carried out at the duly justified request of the competent authority or authorities in another Member State in any such case.

(2) The Licensing Authority shall, upon the request of another Member State or the Commission, provide information on the results of inspections and control measures carried out in relation to the requirements of these regulations.