PART 10Exceptions to requirement for marketing authorisation etc
Exceptions
Exemption for certain radiopharmaceuticals173.
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.