Tuesday, 1 April 2014

Questions (492, 572)

Caoimhghín Ó Caoláin

Question:

492. Deputy Caoimhghín Ó Caoláin asked the Minister for Health the schedule for the introduction of Sativex or similar products; if it is envisaged that this product will be available for patients with multiple sclerosis and chronic pain; if he will outline the regulatory process of bringing such products to market and the standards which apply; and if he will make a statement on the matter. [15510/14]

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Charlie McConalogue

Question:

572. Deputy Charlie McConalogue asked the Minister for Health if he will provide an update on his plans for the use of cannabis for medical reasons; and if he will make a statement on the matter. [15235/14]

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Written answers (Question to Health)

I propose to take Questions Nos. 492 and 572 together.

Under the Misuse of Drugs Act, 1977, the manufacture, production, preparation, sale, supply, distribution and possession of cannabis or cannabis-based medicinal products are unlawful except for the purposes of research. Under European and Irish legislation, before a medicine can be placed on the Irish market the manufacturer has to seek an authorisation from the Irish Medicines Board (IMB) 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 legal and regulatory requirements.

My Department has been informed by the Irish Medicines Board (IMB) that it is in receipt of a market authorisation request from a manufacturer under the EU Mutual Recognition Procedure for a medicinal product containing Cannabis extract. This product is indicated for the relief of symptoms of spasticity for people with multiple sclerosis. Draft Misuse of Drugs (Amendment) Regulations are being prepared to enable authorised cannabis-based medicinal products such as Sativex to be legally prescribed by medical practitioners and used by patients. It is anticipated that the draft Regulations will be introduced in mid-2014.