Ministerial Licence Application Process

This section contains more detailed information for clinicians who require information about the Ministerial licence application process for cannabis-based treatments.

• Under the Misuse of Drugs Act, it is open to the Minister for Health to consider granting a licence to an Irish-registered medical practitioner for access to cannabis for medical use for a named patient(s) under his or her care.
• The Chief Medical Officer has advised that the granting of a Ministerial licence for medical cannabis must be based on an appropriate application being submitted to the Department of Health that is endorsed by a medical consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the treatment over time.

A valid licence application under the Misuse of Drugs Acts must include:

• an outline of the treatment the patient has received to date and justification from the doctor as to why it is appropriate, in their patient’s specific circumstances, to prescribe cannabis.
• details of the cannabis-based product which it is proposed to prescribe and administer to the patient.
• the source of the cannabis-based product.
• the arrangements for the ongoing monitoring and care of the patient once the cannabis-based treatment has commenced.

It is important to note that it will always be the decision of the clinician, in consultation with their patient, to prescribe or not prescribe a particular treatment, including cannabis treatment, for a patient under their care. The Minister for Health has no role in this clinical decision-making process.

Note – The requirements for an application to use cannabis-based treatments are subject to change as the policy on cannabis for medical purposes continues to develop.

Medical practitioners who wish to submit an application or who require further information should contact controlled_drugs@health.gov.ie.

Licence applications received by the Minister for Health are assessed by department officials for compliance with the applicable provisions of the Misuse of Drugs Acts and to ensure they are in line with the advice provided to the Minister by the Chief Medical Officer on the matter. Licence applications are not clinically reviewed. It is the responsibility of the applicant to ensure the clinical appropriateness of the proposed medical cannabis treatment for their patient.

Neither the Minister, nor the Department of Health can make the clinical decision that medical cannabis would be appropriate for the treatment of an individual’s health. The safety and efficacy of cannabis in a large number of medical conditions has yet to be proven. Such products should only be considered for use, after consultation with an individual’s medical advisors and where conventional/existing, evidence-based treatments or therapies have proven unsuccessful or inappropriate for the patient.

Application Process for a Ministerial Licence

In order to ensure a Ministerial licence application submitted by a medical practitioner is valid, a template document is available here, which may be used as a guide in applying for a Ministerial licence.

It is important to note that the Department of Health may request additional contact or particulars from an applicant before considering an individual application to be full and valid.

All applications are treated individually and so processing time for each application may differ, however the department considers all valid applications as priority correspondence and will endeavour to maintain as efficient a processing system as possible.

Any personal data received as part of the application will be subject to the provisions of the General Data Protection Regulation (GDPR) and the Data Protection Acts. To process the application fully it may be necessary to share personal data with the Health Service Executive. In these circumstances the data will be shared for that one purpose only.

For further information see the department’s Data Protection page.