The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

5.—(1) Regulations 3(1) shall not apply to a radiopharmaceutical for human use(1) —

(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).

(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.

(1)

See article 2 of Council Directive 89/343/EEC.

(2)

S.I. 1978/1006.