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Home > Dail Eireann debate. Written answer 472 - Medicinal products licensing [Cannabidiol medical marijuana] [11587/16].

[Oireachtas] Dail Eireann debate. Written answer 472 - Medicinal products licensing [Cannabidiol medical marijuana] [11587/16]. (24 May 2016)

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472. Deputy Clare Daly asked the Minister for Health if he has reviewed the evidence for the efficacy of cannabidiol medical marijuana in treating the symptoms of Dravet syndrome; if he will license it for this treatment; if not, the reason for same; his plans to legalise medical marijuana for the treatment of other conditions.; and if he will make a statement on the matter. [11587/16]


Minister for Health (Deputy Simon Harris): Cannabidiol (CBD) oil is not authorised as a medicinal product in Ireland. I have no role in the process of authorising medicinal products. Under European and Irish legislation, before a medicine can be placed on the Irish market, the manufacturer must seek an authorisation from the Health Products Regulatory Authority (HPRA) or, in the case of certain medicinal products, the European Medicines Agency. A determination on an application for authorisation of a medicine is based on a rigorous scientific assessment of the application against the criteria of safety, quality, efficacy, legal and regulatory requirements.


Where a medicine is not authorised in Ireland, a licensed wholesaler may import it if it has been prescribed by a doctor for a patient under his/her care, on his/her direct responsibility and in order to meet the special needs of a patient. The process for this is described in the ‘Guide to the Notification System for Exempt Medicinal Products’ which is available on the HPRA website. For this notification scheme, there are a number of specialist wholesalers which deal with the importation of ‘exempt medicines’ into Ireland, via pharmacies and subject to a prescription.


CBD is derived from cannabis which is a controlled drug. If a CBD oil product does not contain an ingredient which is a controlled substance, it may be feasible to have that product imported and used in Ireland, in accordance with specific conditions, should a patient’s doctor be of the opinion that this is an appropriate treatment.


My Department is aware that cannabis for medicinal use has been legalised in some countries and that there have been several studies internationally on the therapeutic effects of cannabinoids for a number of medical issues. In July 2014, the Misuse of Drugs Regulations were amended to allow for certain cannabis based medicinal products to be used in Ireland. Subsequently the HPRA granted a marketing authorisation for a cannabis based medicinal product which is indicated for the relief of certain symptoms for people with multiple sclerosis.


My Department will continue to keep developments in relation to cannabis based medical products under review

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