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1.—(1) This Order may be cited as the Medicines (Exemption from Licensing) (Radiopharmaceuticals) Order 1992 and shall come into force on 11th December 1992.
(2) In this Order—
“generator” means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and is to be used in a radiopharmaceutical;
“kit” means any preparation to be reconstituted or combined with radionuclides in a final radiopharmaceutical, usually prior to its administration;
“precursor” means a radionuclide produced for the radio-labelling of another substance prior to its administration, other than a radionuclide which is incorporated in or produced from a generator or is included in a radiopharmaceutical;
“radiopharmaceutical” means any medicinal product which when ready for use contains one or more radionuclides included for a medicinal purpose.
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