The Medicines (Exemption from Licensing) (Radiopharmaceuticals) Order 1992 No. 2844

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(1).

(1)

S.I. 1978/1006.