Amendment of regulation 2 of the 2001 Regulations3
In regulation 2(1) of the 2001 Regulations5 (interpretation) at the appropriate places insert—
“cannabis-based product for medicinal use in humans” means a preparation or other product, other than one to which paragraph 5 of part 1 of Schedule 4 applies, which—
- a
is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers);
- b
is produced for medicinal use in humans; and—
- c
is—
- i
a medicinal product, or
- ii
a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product;
“clinical trial” has the same meaning as in the Medicines for Human Use (Clinical Trials) Regulations 20046;
“dronabinol” does not include any substance which—
- a
has the international non-proprietary name dronabinol (recommended by the World Health Organisation); and
- b
is derived from cannabis, cannabis resin or their constituents,
and stereoisomers of dronabinol are to be construed accordingly;; and
“medicinal product” has the same meaning as in the Human Medicines Regulations 20127;