PART 12Dealings with medicinal products
CHAPTER 3Exemptions
Exemptions in relation to specific kinds of product
Radioactive medicinal products240.
(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)
(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)
(5)
Condition D is that the prescription only medicine is not a controlled drug.
(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.