S.L. 458.33 Art. 13Duty of the Authority.

It shall be the duty of the Authority to ensure that a detailed instruction leaflet in accordance with the provisions of regulation 7 is enclosed with the packaging of radio-pharmaceuticals, radionuclide generators, radionuclide kits and radionuclide precursors. The leaflet shall also include any precautions to be taken by the user and the patient during the preparation and administration of the medicinal product and special precautions for the disposal of the packaging and its unused contents.