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Home > Dail Eireann debate. Written answer 668 - Medicinal products licensing [Sativex] [24360/13].

[Oireachtas] Dail Eireann debate. Written answer 668 - Medicinal products licensing [Sativex] [24360/13]. (21 May 2013)

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688. Deputy Patrick Nulty asked the Minister for Health if he will expedite the approval of sativex medication, for the treatment of persons with multiple sclerosis; if his attention has been drawn to the fact that the European Mutual Recognition Procedure has been ratified in this regard; and if he will make a statement on the matter. [24360/13] 

Minister of State at the Department of Health (Deputy Alex White): My 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.


Under the Misuse of Drugs Act, 1977, the manufacture, production, preparation, sale, supply, distribution and possession of cannabis or cannabis-based medicinal products are unlawful except for the purposes of research.


Department officials have been engaging with experts to identify how best to legally describe authorised cannabis-based medicinal products while maintaining existing controls on cannabis and cannabis substances. The matter is being progressed as quickly as possible in my Department and it is hoped to bring forward legislative proposals in mid-2013.

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