Press Release

Minister White signs New Regulations to provide for cannabis-based medicinal products

Minister of State for Primary Care Alex White T.D. today, (Friday 11th July 2014), signed regulations to enable authorised cannabis-based medicinal products to be legally prescribed by medical practitioners and used by patients.

“I’m glad that many of the matters that had inhibited the progress of this issue have now been resolved. Hopefully, with the legal impediments now removed, a cannabis-based medicinal product will soon be available to ease the symptoms of spasticity for people with multiple sclerosis where other conservative treatments have failed” said the Minister.

The Misuse of Drugs Regulations, made under the Misuse of Drugs Act 1977, are the primary legislative instrument regulating the import, export, manufacture, production, prescribing, supply, possession and administration of controlled drugs within the Irish health system.  The granting of approval enabling this product to be used in Ireland was dependent on changes to the Misuse of Drugs Regulations.

The amending regulations also introduce a handwriting exemption in respect of prescriptions for methadone. This means that the following information will now not be required to be handwritten:  name and address of the patient; dose/quantity/strength of the preparation to be taken; and instalment intervals.

Ends

Notes for Editors
The Misuse of Drugs Regulations, made under the Misuse of Drugs Act 1977, are the primary legislative instrument regulating the import, export, manufacture, production, prescribing, supply, possession and administration of controlled drugs within the Irish health system.

A consultation process was held in July 2012 with key stakeholders in relation to a wide range of proposed amendments to the Misuse of Drugs Regulations, on foot of which draft Regulations were prepared and placed on the Department’s website inviting further comment by early September 2013.

Over 90 submissions were received, raising complex issues, and work is ongoing in the Department in relation to legislation on other issues which formed part of the consultation process.

The Health Products Regulatory Authority (HPRA) received a market authorisation request from a manufacturer under the EU Mutual Recognition Procedure for a medicinal product containing cannabis extract.   This product is used for the relief of symptoms of spasticity for people with multiple sclerosis.

The HPRA completed its assessment of the product and, based on quality, safety and efficacy, recommended its approval for the Irish market.

The granting of approval enabling this product to be used in Ireland was dependent on changes to the Misuse of Drugs Regulations.