Home > Dail Eireann debate. Written answer 577 - Medicinal products licensing [26588/16].

[Oireachtas] Dail Eireann debate. Written answer 577 - Medicinal products licensing [26588/16]. (27 Sep 2016)


577. Deputy Billy Kelleher asked the Minister for Health the process that must be undergone for a medicines manufacturer to have cannabis based product authorised for use by patients. [26588/16]

Minister of State at the Department of Health (Deputy Catherine Byrne):  Under European and Irish legislation, before a medicine can be placed on the Irish market the manufacturer has to 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.

Under the Misuse of Drugs Acts 1977 to 2016 and the Regulations made thereunder, the manufacture, production, preparation, sale, supply, distribution and possession of cannabis and certain cannabis-related compounds is currently unlawful except under licence. However, the scope for such licences to be issued is restricted to a limited number of specific circumstances. This is in line with the international controls on cannabis as prescribed under the United Nations Single Convention on Narcotic Drugs 1961.

In July 2014, the Misuse of Drugs Regulations 1988, were amended to allow for a specific cannabis-based medicinal product to be used in Ireland. This derogation was facilitated based on evidence from scientific data submitted by a company to demonstrate the quality, safety and efficacy of this specific medicine and its ability to provide a clear medical benefit for patients with multiple sclerosis, warranting its authorisation as a medicine and its inclusion as a Schedule 2 controlled drug. Subsequently the HPRA granted a marketing authorisation for Sativex Oromucosal Spray to be marketed in the State for the relief of symptoms of spasticity for people with multiple sclerosis where other conservative treatments have failed to provide adequate benefits.

To date, the HPRA has not received any applications for authorisation for any further cannabis-based products, but remains open to doing so. If other cannabis-based medications come to market, and the marketing authorisation holder seeks to have the product made available in Ireland, it is likely that further legislative changes may be required to accommodate such a product.

Item Type:Dail Debates
Source:Oireachtas
Date:27 September 2016
EndNote:View
Related URLs:
Subjects:B Substances > Cannabis / Marijuana
B Substances > Cannabis product (synthetic cannabinoids)
E Concepts in biomedical areas > Substance by legal status
VA Geographic area > Europe > Ireland

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