Amendment of the Misuse of Drugs Regulations 2001

2.—(1) The Misuse of Drugs Regulations 2001(1) are amended as follows.

(2) In regulation 2 (interpretation), in the definition of “cannabis-based product for medicinal use in humans”(2), for “Schedule 4 applies” substitute—

Schedule 4, or paragraph 10 of Schedule 5, applies.

(3) In paragraph 1(a) of Schedule 1 (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 19, 20, 23, 26 and 27), for “Cannabinol derivatives not being dronabinol or its stereoisomers” substitute—

Cannabinol derivatives not being—

(i)dronabinol or its stereoisomers; or

(ii)the substance specified in paragraph 10 of Schedule 5.

(4) In Schedule 5 (controlled drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 24 and 26), after paragraph 9 insert—

10.  A liquid formulation—

(a)containing cannabidiol obtained by extraction and purification from cannabis;

(b)where the concentration of—

(i)delta-9-tetrahydrocannabinol is not more than 0.1 milligram per millilitre; and

(ii)cannabidiol is 95-105 milligrams per millilitre;

(c)which is presented in a bottle, as an oral solution for oral administration; and

(d)which was approved for marketing by the European Commission on 19th September 2019. (3).

(2)

This definition was inserted by S.I. 2018/1055.

(3)

https://ec.europa.eu/health/documents/community-register/html/h1389.htm; a hard copy can be obtained from the Home Office at 2 Marsham Street, London SW1P 4DF.