PART 10 U.K.Exceptions to requirement for marketing authorisation etc

Exceptions U.K.

Exemption for certain radiopharmaceuticals U.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 [F1 UK marketing authorisation or EU marketing authorisation] is in force; and

[F2 (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

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 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))