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The Human Medicines Regulations 2012, Section 240 is up to date with all changes known to be in force on or before 18 August 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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240.—(1) Regulation 214(2) does not apply to—
(a)a radioactive medicinal product, administration of which results in a medical exposure; or
(b)any other prescription only medicine if it is being administered in connection with a medical exposure,
if the following conditions are met.
(2) Condition A is that the prescription only medicine is administered by an operator acting in accordance with the procedures and protocols referred to in regulation 4(1) and (2) of the Ionising Radiation (Medical Exposure) Regulations 2000 M1 which apply to the exposure.
(3) Condition B is that the medical exposure has been authorised by—
(a)an IRME practitioner; or
(b)where it is not practical for an IRME practitioner to authorise the exposure, by an operator acting in accordance with written guidelines issued by an IRME practitioner.
(4) Condition C is that the IRME practitioner mentioned in paragraph (a) or (b) of paragraph (3) is the holder of a certificate granted pursuant to the Medicines (Administration of Radioactive Substances) Regulations 1978 M2.
(5) Condition D is that the prescription only medicine is not a [F1product subject to special medical prescription].
(6) Condition E is that, in the case of a prescription only medicine that is not a radioactive medicinal product, it is specified in the protocols referred to in paragraph (2).
(7) In this regulation—
“IRME practitioner” means, in relation to a medical exposure, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2000;
“medical exposure” has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000; and
“radioactive medicinal product” means a medicinal product which consists of, contains or generates a radioactive substance so that, when the product is administered, the radiation it emits may be used.
Textual Amendments
F1Words in reg. 240(5) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(f) and words in reg. 240(5) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(f)
Marginal Citations
M1S.I. 2000/1059, as amended by S.I. 2006/2523.
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