# The Human Medicines Regulations 2012, Regulation 173: Exemption for certain radiopharmaceuticals

Extent: E+W+S+N.I.

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 UK marketing authorisation ... is in force; and
(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.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/173 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-173
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.