The Misuse of Drugs (Designation) (Amendment No.2) Order (Northern Ireland) 2018

Type Ni-Statutory-Rule
Publication 2018-10-11
State In force
Jurisdiction Northern Ireland
Department Government Printer for Northern Ireland
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Made: 11th October 2018

Coming into operation: 1st November 2018

The Department of Health[^f00001] makes the following Order in exercise of the powers conferred by section 7(4) and (5) of the Misuse of Drugs Act 1971[^f00002], as adapted by section 7(9) of that Act and now vested in it[^f00003] and after consultation with the Advisory Council on the Misuse of Drugs in accordance with section 7(7) of that Act.

Citation, commencement and interpretation

1

Amendment of the Misuse of Drugs (Designation) Order (Northern Ireland) 2001

2

(5) (1) A cannabis based product for medicinal use in humans. (2) A product which is— (a) specified in Part 1 as a consequence of the application of paragraphs 2 to 5 of Part 1 to a preparation or other product (not being the substance specified in paragraph 4 of Part 2) which is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers ); and (b) produced for medicinal use in humans. (3) In this paragraph— - “cannabis based product for medicinal use in humans” means a preparation or other product (not being the substance specified in paragraph 4 of Part 2), which— is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers); is produced for medicinal use in humans; and is— a medicinal product, or a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product; and - “medicinal product” has the same meaning as in the Human Medicines Regulations 2012[^f00007]. (4) In this Schedule “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.

Signed

Sealed with the Official Seal of the Department of Health on 11th October 2018

Dr Mark Timoney — A senior officer of the — Department of Health

Explanatory note

(This note is not part of the Order)

EXPLANATORY NOTE

Section 7(3) of the Misuse of Drugs Act 1971 (c.38) (the 1971 Act) requires regulations to be made to allow the use for certain purposes, including medical use, of the drugs which are subject to control under that Act. Section 7(4)(b) of the 1971 Act provides, however, that designated controlled drugs will be exempt from this easement and so cannot lawfully be prescribed, administered, produced, compounded or supplied except under licence or other authority issued by the Department of Health. The designations in question are in the Misuse of Drugs (Designation) Order (Northern Ireland) 2001 (the 2001 Order) and include cannabis, cannabis resin, cannabinol and cannabinol derivatives not being dronabinol or its stereoisomers. Article 2 varies the 2001 Order to exclude cannabis based products for medicinal use in humans, and some related products, from the relevant designations.

Footnotes

[^f00001]: The Department of Health, Social Services and Public Safety was renamed the Department of Health by section 1(5) of the Departments Act (Northern Ireland) 2016 (c. 5) (N.I.)

[^f00002]: 1971 c.38, as amended by section 151 of, and Schedule 17 to, the Police Reform and Social Responsibility Act 2011 (c. 13)

[^f00003]: S.R.&O. (N.I.) 1973 No. 504, Article 5(a) and S.I. 1999/283 (N.I.), Article 3(6)

[^f00004]: 1954 c.33 (N.I.)

[^f00005]: S.R. 2001 No. 431, relevant amending Orders are S.R. 2018 No. 3, S.R. 2015 Nos. 228 and 54, S.R. 2014 Nos. 262, 159 and 20, S.R. 2013 No. 77, S.R. 2012 No. 212, S.R. 2011 No. 154, S.R. 2010 Nos. 246 and 149, S.R. 2009 No. 389 and S.R. 2005 No. 359

[^f00006]: Paragraph 1 of Part 1 of Schedule 1 has been amended by S.R. 2018 No. 3

[^f00007]: S.I. 2012/1916. See the definition of “medicinal product” in regulation 2.

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