# The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, Paragraph 5


(1) Regulations 3(1) shall not apply to a radiopharmaceutical for human use —
(a) which is prepared at the time at which it is intended to be administered; and
(b) which is prepared, in accordance with the manufacturer’s instructions and by the person by whom it is to be administered, exclusively from a kit, generator or precursor (or from more than one of these) in respect of which a marketing authorization is in force; and
(c) the administration of which is not or will not be a contravention of regulation 2 of the Medicines (Administration of Radioactive Substances) Regulations 1978.
(2) In this paragraph—
“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 relevant medicinal product which when ready for use contains one or more radionuclides included for a medicinal purpose.

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Source: https://www.legislation.gov.uk/uksi/1994/3144/schedule/1/paragraph/5 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.