Dáil Éireann Debate, Wednesday - 24 October 2012
231. Deputy Luke 'Ming' Flanagan asked the Minister for Health the reason this country needs to put cannabis based medicines of which Sativex is one such brand through clinical trials when the products are already clinically approved by the Mutual Recognition Procedure which operates throughout Europe; if the Irish Medicines Board has already approved such medicines; and if he will make a statement on the matter. [46550/12]
Amharc ar fhreagraMy Department has been informed by the Irish Medicines Board (IMB) that it is in receipt of a market authorisation request from a manufacturer under the EU Mutual Recognition Procedure for a medicinal product containing Cannabis extract. This product is indicated for the relief of symptoms of spasticity for people with multiple sclerosis. Clinical trials in Ireland relating to this product will not be required. Department officials are currently examining how best to legally describe authorised cannabis-based medicinal products so that they may be prescribed to patients in Ireland while maintaining existing controls on cannabis and cannabis substances similar to those that apply to other controlled drugs that can be misused. It is hoped to bring forward legislative proposals in early 2013.
