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Insertion of article 7B of the POM Order

3.  After article 7A of the POM Order insert the following article—

“Exemption for administration by operators

7B.—(1) The restriction imposed by section 58(2)(b) (restriction on administration) shall 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,

where the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to in paragraph (1) are that—

(a)the radioactive medicinal product or other 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 which apply to the exposure referred to in paragraph (1);

(b)that medical exposure has been authorised by an IRME practitioner or, where it is not practicable for an IRME practitioner to authorise the exposure, by an operator acting in accordance with written guidelines issued by an IRME practitioner;

(c)the IRME practitioner is the holder of a certificate granted pursuant to the Medicines (Administration of Radioactive Substances) Regulations 1978(1);

(d)the radioactive medicinal product or other prescription only medicine is not a controlled drug; and

(e)in the case of a prescription only medicine which is not a radioactive medicinal product, it is specified in the protocols referred to in sub-paragraph (a).”