Database of innovative medical treatments
3Section 2: supplementary
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 F1UK 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 F2UK marketing authorisation is in force;
b
“F3UK 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 F4UK 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.