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—

    1. a

      is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers);

    2. b

      is produced for medicinal use in humans; and—

    3. c

      is—

      1. i

        a medicinal product, or

      2. 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—

    1. a

      has the international non-proprietary name dronabinol (recommended by the World Health Organisation); and

    2. 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;