Written answers
Tuesday, 24 January 2017
Department of Health
Medicinal Products Licensing
Jonathan O'Brien (Cork North Central, Sinn Fein)
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402. To ask the Minister for Health the Health Products Regulatory Authority plans to have cannabidiol made available by prescription for treatment of epilepsy. [2587/17]
Simon Harris (Wicklow, Fine Gael)
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Cannabidiol (CBD) is derived from cannabis. However, since it does not have psychoactive properties it is not controlled under the Misuse of Drugs Acts.
While I am aware that CBD oil is sometimes marketed as a nutritional or dietary supplement, it should be noted that it is not authorised as a medicinal product in Ireland. 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 medicinal product is based on a rigorous scientific assessment of the application against the criteria of safety, quality, efficacy, legal and regulatory requirements. I have no role in the process of authorising medicinal products.
No application has been received from any company for any products containing CBD. The HPRA are open to receiving such applications.
Elsewhere products containing CBD are undergoing clinical trials for the treatment of a number of medical conditions, including severe, intractable (treatment-resistant) epilepsy. There is no prohibition on an Irish registered doctor recommending CBD for a patient under his/her care if they deem that treatment option to be clinically appropriate for their patient.
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