Exemption for certain radiopharmaceuticalsU.K.
173. Regulation 46 (requirement for authorisation) does not apply where a radiopharmaceutical is prepared—
(a)at the time when it is intended to be administered;
(b)in accordance with the manufacturer's instructions and by the person by whom it is to be administered;
(c)from radionuclide generators, radionuclide kits and radionuclide precursors in respect of which a marketing authorisation is in force; and
[F1(d)for administration—
(i)in England and Wales and Scotland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017;
(ii)in Northern Ireland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.]
Textual Amendments
F1Reg. 173(d) substituted (6.2.2018) by The Ionising Radiation (Medical Exposure) Regulations 2017 (S.I. 2017/1322), reg. 1, Sch. 4 para. 2(2) (as substituted (6.2.2018) by S.I. 2018/121, regs. 1(2), 2(4)(b)(i))