Billy Kelleher (Cork North Central, Fianna Fail)
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437. To ask the Minister for Health the position with regard to the certification of cannabidiol; and if he will make a statement on the matter. [5724/17]

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 medicinal product authorisation.

With the exception of Sativex, which has been authorised and is indicated for the treatment of spasticity for sufferers of Multiple Sclerosis, 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.