Written answers

Thursday, 18 October 2012

Department of Children and Youth Affairs

Medical Products

Photo of Luke FlanaganLuke Flanagan (Roscommon-South Leitrim, Independent)
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To ask the Minister for Health the reason it is expected to take at least 18 months to bring legislation to Dáil Éireann for the introduction of cannabis based medicine for the relief of pain for certain ailments such as multiple sclerosis, glaucoma and others; if it is necessary to run clinical trials when the medicine has already been tested and approved in the UK and Belgium; and if he will make a statement on the matter. [45541/12]

Photo of Alex WhiteAlex White (Dublin South, Labour)
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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.

The Department has been informed by the Irish Medicines Board (IMB) that it has received 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 have been engaging with experts on how best to legally describe authorised cannabis-based medicinal products while maintaining existing controls on cannabis and cannabis substances to enable such authorised medicinal products to be prescribed in Ireland and used by patients. While it is not possible to set out an exact timeframe, it is hoped to bring forward legislative proposals in early 2013.

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