Regulation 173 Exemption for certain radiopharmaceuticals

United Kingdom

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 F1UK marketing authorisation F2... is in force; and

F3(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.

Annotations

F1: Words in reg. 173(c) substituted (31.12.2020) by S.I. 2019/775, reg. 138 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 106); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in reg. 173(c) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 73
F3: Reg. 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))