S.L. 458.33 Art. 12Radionuclides.

(1) In the case of radionuclides, the outer carton and container of the medicinal product shall be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency. Moreover, the labelling, whether in printed form or by means of the electronic package leaflet shall comply with the provisions set out in sub-regulations (2) and (3).

(2) The label on the shielding shall include the particulars mentioned in regulation 3 and shall:

(a) explain in full, the codings used on the vial, and

(b) indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial and the number of capsules, or, for liquids, the number of millilitres in the container.

(3) The vial shall be labelled with the following information:

(a) the name or code of the medicinal product, including the name or chemical symbol of the radionuclide,

(b) the batch identification and expiry date,

(c) the international symbol for radioactivity,

(d) the name and address of the manufacturer,

(e) the amount of radioactivity as specified in subregulation (2).