Statutory Rules of Northern Ireland
21st March 2013
Coming into operation
10th April 2013
The Department of Health, Social Services and Public Safety makes the following Order in exercise of the powers conferred by section 7(4) of the Misuse of Drugs Act 1971(1) as adapted by section 7(9) of that Act and now vested in it(2) and after consultation with the Advisory Council on the Misuse of Drugs in accordance with section 7(7) of that Act.
1.-(1) This Order may be cited as the Misuse of Drugs (Designation) (Amendment) Order (Northern Ireland) 2013 and shall come into operation on 10th April 2013.
(2) The Interpretation Act (Northern Ireland) 1954(3) shall apply to this Order as it applies to an Act of the Assembly.
2. The Misuse of Drugs (Designation) Order (Northern Ireland) 2001(4) is amended as provided by Articles 3 and 4.
3. In paragraph 1(a) of Part I of the Schedule (which specifies controlled drugs to which section 7(4) of the Misuse of Drugs Act 1971 applies) after "Cannabis" insert "(not being the substance specified in paragraph 4 of Part II of this Schedule)".
4. After paragraph 3 of Part II of the Schedule (which specifies controlled drugs excepted from Part I)(5) insert-
"4. A liquid formulation-
(a)containing a botanical extract of cannabis-
(i)with a concentration of not more than 30 milligrams of cannabidiol per millilitre, and not more than 30 milligrams of delta-9-tetrahydrocannabinol per millilitre, and
(ii)where the ratio of cannabidiol to delta-9-tetrahydrocannabinol is between 0.7 and 1.3,
(b)which is dispensed through a metered dose pump as a mucosal mouth spray, and
(c)which was approved for marketing by the Medicines and Healthcare products Regulatory Agency on 16th June 2010(6)"
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 21st March 2013
A senior officer of the
Department of Health, Social Services and Public Safety
(This note is not part of the Order)
This Order further amends the Misuse of Drugs (Designation) Order (Northern Ireland) 2001. Section 7(3) of the Misuse of Drugs Act 1971 requires regulations to be made to allow the use for medical purposes of the drugs which are subject to control under that Act. Section 7(3) does not apply to any drug designated by order under section 7(4) as a drug to which section 7(4) is to apply. Cannabis is designated in paragraph 1(a) of Part I of the Schedule to the Misuse of Drugs (Designation) Order (Northern Ireland) 2001 as a drug to which section 7(4) applies, and this Order specifically excludes the cannabis-based medicine "Sativex" from such designation.
A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk.
S.R & O. (N.I) 1973 No.504, Article 5(a) and S.I. 1999 No.283(N.I.1);Article 3(6)
1954 c.33 (N.I)
Paragraph 3 was inserted by article 4 of S.R. 2009 No.389.
The approval may be accessed at http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con084961.pdf.