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Access to Medical Treatments (Innovation) Act 2016

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3Section 2: supplementary

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(1)In section 2, “doctor” means a registered medical practitioner.

(2)For the purposes of section 2(2), the kinds of medical treatment that may be innovative medical treatments include (amongst other things)—

(a)the off-label use of an authorised medicinal product, and

(b)the use of a medicinal product in respect of which no marketing authorisation is in force.

(3)In subsection (2)(a), the reference to the off-label use of an authorised medicinal product is a reference to the use of the product—

(a)for a purpose other than one for which its use is specified,

(b)in relation to a person who is not within a description of persons for whom its use is specified, or

(c)in any other way in which its use is not specified.

(4)In this section—

(a)“authorised medicinal product” means a medicinal product in respect of which a marketing authorisation is in force;

(b)“marketing authorisation” and “medicinal product” have the same meanings as in the Human Medicines Regulations 2012 (S.I. 2012/1916);

(c)“specified”, in relation to a medicinal product, means specified in its marketing authorisation.

(5)References in section 2 to medical treatment include references to treatment carried out for the purposes of medical research (but nothing in section 2 is to be read as affecting the regulation of medical research).

(6)Nothing in section 2 applies in relation to treatment which is carried out solely for cosmetic purposes.

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