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4. After paragraph 3 of Part II of the Schedule (which specifies controlled drugs excepted from Part I)(1) 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(2)”
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.
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