Written answers

Thursday, 14 April 2016

Department of Health

Medicinal Products Licensing

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
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593. To ask the Minister for Health the status of a medication called Charlotte's Web which is used in the treatment of a condition called West syndrome or Travis syndrome; and if he will make a statement on the matter. [7053/16]

Photo of Leo VaradkarLeo Varadkar (Dublin West, Fine Gael)
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Charlotte's Web is a cannabis based product. Cannabis and certain cannabis-related compounds are controlled under the Misuse of Drugs Acts 1977 to 2015 and are listed in schedule 1 of the Misuse of Drugs Regulations 1988, as amended.

Charlotte's Web is not an authorised 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 (EMA). 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. I have no role in the process of authorising medicinal products.

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