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The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2018

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EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Ionising Radiation (Medical Exposure) Regulations 2017 (S.I. 2017/1322) (“the 2017 Regulations”). In order to give full effect to the policy intention and to correct errors in the 2017 Regulations, these Regulations come into force immediately after the coming into force of the 2017 Regulations.

Regulation 2 amends the 2017 Regulations by:

  • inserting appropriate references to territorial extent and application

  • correcting an erroneous cross-reference

  • amending the Justification of Practices Involving Ionising Radiation Regulations 2004 (S.I. 2004/1769) to provide that the restriction of practices resulting in exposure to ionising radiation in certain cases does not prevent anything done under regulation 11 of the 2017 Regulations or regulation 11 of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 (which deal with justifications for individual exposures to such radiation)

  • amending the Human Medicines Regulations 2012 (S.I. 2012/1916)—

    • so that the requirement for an authorisation under regulation 46 of those Regulations does not apply where a radiopharmaceutical is prepared in accordance with a licence issued under the 2017 Regulations or the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018

    • to disapply, where specified conditions are met, the prohibition in section 214(2) of those Regulations on a person parenterally administering (save in specified circumstances) a prescription only medicine.

A full impact assessment has not been prepared for this instrument as it has a low cost to business.

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