Amendment of Schedule 4

6.  After paragraph 4 of Part I of Schedule 4 (controlled drugs subject to the requirements of regulations 22, 23, 26 and 27) insert—

5.  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(1).