Regulation 263 Leaflets relating to radionuclides
(1)
The licensing authority must ensure that a detailed instruction leaflet is enclosed with—
(a)
radiopharmaceuticals;
(b)
radionuclide generators;
(c)
radionuclide kits; or
(d)
radionuclide precursors.
(2)
The leaflet must include the information specified in Schedule 27.
(3)
The leaflet must also include—
(a)
any precautions to be taken by the user and the patient during the preparation and administration of the medicinal product; and
(b)
special precautions for the disposal of the packaging and its unused contents.