Citation, interpretation and commencement

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.

Exemption for certain radiopharmaceuticals assembled at the time of administration

2.  Section 7 of the Medicines Act 1968 (requirements as to product licences) shall not apply to anything done in relation 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 product licence is in force; and

(c)the administration of which is not a contravention of regulation 2 of the Medicines (Administration of Radioactive Substances) Regulations 1978(4).

Explanatory Note

(This note is not part of the Order)

This Order exempts from the restrictions imposed by section 7 of the Medicines Act 1968 (product licences) a radiopharmaceutical product for human use if it is prepared from a kit, generator or precursor which itself has a product licence, where the radiopharmaceutical product is prepared at the time of its administration and where that administration is not a contravention of regulation 2 of the Medicines (Administration of Radioactive Substances) Regulations 1978.

This Order implements in part article 2 of Council Directive 89/343/EEC (OJ No. L142 25.5.89 p.16) which extends the scope of Council Directives 65/65/EEC (OJ No. 22 9.2.1965 p.369/65) and 75/319/EEC (OJ No. L147 9.6.1975 p.13) and which lays down additional provisions for the control of radiopharmaceuticals.