Exemption for certain radiopharmaceuticals assembled at the time of administration2

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 19784.