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Statutory Rules of Northern Ireland

2020 No. 104

Dangerous Drugs

The Misuse of Drugs (Amendment No. 2) Regulations (Northern Ireland) 2020

Made

12th June 2020

Coming into operation

24th June 2020

The Department of Health(1) makes the following Regulations in exercise of the powers conferred by sections 7, 10, 22 and 31 of the Misuse of Drugs Act 1971(2) as adapted by sections 7(9), 31(4) and 38 of that Act and now vested in it(3) and after consultation with the Advisory Council on the Misuse of Drugs in accordance with section 31(3) of that Act.

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Misuse of Drugs (Amendment No. 2) Regulations (Northern Ireland) 2020 and shall come into operation on 24th June 2020.

(2) The Interpretation Act (Northern Ireland) 1954(4) shall apply to these Regulations as it applies to an Act of the Northern Ireland Assembly.

Amendment of the Misuse of Drugs Regulations (Northern Ireland) 2002

2.  The Misuse of Drugs Regulations (Northern Ireland) 2002(5) are amended as follows.

(1) In regulation 2 (2) (interpretation), in the definition of “cannabis-based product for medicinal use in humans”(6), for “Schedule 4 applies” substitute—

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

(2) 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.

(3) 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..

Sealed with the Official Seal of the Department of Health on 12th June 2020.

(L.S.)

Cathy Harrison

A senior officer of the Department of Health

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Misuse of Drugs Regulations (Northern Ireland) 2002 (S.R. 2002 No. 1) to provide for a specified cannabis-based medicine to be placed in Schedule 5 of the Regulations. The effect of this is that the specified product is exempt from the prohibitions on import, export and possession under sections 3 and 5 of the Misuse of Drugs Act 1971.

(1)

Formerly the Department of Health, Social Services and Public Safety, see 2016 c. 5 (N.I.), s. 1(5)

(2)

1971 c. 38. Section 7 was amended by the Police Reform and Social Responsibility Act 2011 (c. 13) (“the 2011 Act”), Sch 17, para 7. Section 10 was amended by the 2011 Act, Sch 17, para 10. Section 22 was amended by s. 177(1) of, and para 12 of Sch 4 to, the Customs and Excise Management Act 1979 (c. 2). Section 31 has been amended by the Drugs Act 2005 (c. 17), s. 2, and the Policing and Crime Act 2009 (c. 26), Sch 7, para 122, and Sch 8, Part 13. Section 38 was amended by the 2011 Act, Sch 17, para 20. See the definition of “prescribed” in s. 37(1) (as adapted by s. 38), which is relevant to the powers being exercised

(3)

S.R. & O. (N. I.) 1973 No. 504, Article 5(a) and S.I. 1999/283 (N.I. 1), Article 3(6)

(5)

S.R. 2002 No. 1. Relevant amending Regulations are S.R. 2020 No. 73, S.R. 2019 Nos. 208 and 21, S.R. 2018 Nos. 173 and 4, S.R. 2016 No. 29, S.R. 2015 No. 227, S.R. 2015 No. 53, S.R. 2014 Nos. 261, 158 and 21, S.R. 2013 No. 78, S.R. 2012 No. 213, S.R. 2011 No. 153, S.R. 2010 Nos. 247 and 148, S.R. 2009 No. 390, S.R. 2007 No. 348 and S.R. 2005 No. 360

(6)

This definition was inserted by S.R. 2018 No. 173