Medical Cannabis Access Programme
The Misuse of Drugs (Prescription and control of supply of cannabis for medical use) Regulations 2019 outline the legal framework and details of the Medical Cannabis Access Programme in Ireland. These Regulations enable the importation, prescribing and supply of cannabis-based products or preparations, known as ‘specified controlled drugs’, that meet the requirements of the Regulations and have been included in Schedule 1 of the Regulations.
If a product meets the requirements of the Regulations, a company may apply to the HPRA (who process the application on behalf of the Minister for Health), to have it added to Schedule 1 of the Regulations.
The HPRA has developed guidance on the requirements to be fulfilled in order for a cannabis-based product or preparation to be considered by the Minister of Health for inclusion in Schedule 1 of the Regulations. This can be found in Appendices 1 and 2 of the Guide to Import and Export Licences and Letters of No Objection for Controlled Drugs.
Application form for cannabis products or preparations
Application for products to be considered for inclusion in Schedule 1 of the Misuse of Drugs (Prescription and control of supply of cannabis for medical use) Regulations 2019
Cannabis-based products in Schedule 1 of the Regulations
The current list of specified controlled drugs (cannabis-based products), that have been accepted for use under the Medical Cannabis Access Programme, is published on the Department of Health’s website.
Controlled drug licences
All products included in Schedule 1 of the Regulations will be also included in Schedule 2 of the Misuse of Drugs Regulations 2017. A separate annual licence is required to possess, supply or offer to supply, a controlled drug described in Schedule 2 of the Misuse of Drugs Regulations 2017. In addition to an annual licence, an import licence is required to accompany each import consignment.
The relevant forms with which to apply for these licences are available on Controlled Drugs Licences page of our website.
The Department of Health has also published information on the Medical Cannabis Access Programme, including FAQs.