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.