A prospective supplier of cannabis-based products can apply to the Health Products Regulatory Authority (HPRA), on behalf of the Minister, to have a cannabis-based product considered for inclusion in the Medicinal Cannabis Access Programme.
Cannabis-based products that can be used in the Medicinal Cannabis Access Programme are defined as ‘specified controlled drugs’ in legislation (SI 262/2019) and the definition outlines the specific requirements for those products.
The criteria that cannabis-based products must meet in order to be considered by the Minister for inclusion on the schedule are set out in the legislation and can be found in the operator guidance issued by the HPRA.
The manufacturers of the prescribed cannabis-based products availed of by patients (whose clinicians are licenced under the Misuse of Drugs Acts 1977-2016) from a pharmacy in the Netherlands have not sought to have their products included in the Medicinal Cannabis Access Programme.
Due to current Netherlands government policy, the prescribed cannabis-based oil formulations are not permitted to be commercially exported from the Netherlands but are only supplied in the Netherlands to Irish patients on an individual basis on foot of a valid medical prescription when presented to the appropriate pharmacy.
Representations were made to the Dutch authorities to facilitate the export of the products to Ireland. The Dutch authorities confirmed that the export of cannabis oils to foreign pharmacies or wholesalers is not permitted and that magistral preparations may only be provided directly to patients or their representative on the basis of a prescription.
In April 2020, as a result of the Covid 19 pandemic the Department initiated a collection and delivery process of cannabis-based products form the Netherlands to patients homes for patients of clinicians licenced under Section 14 of the Misuse of Drugs Acts to prescribe controlled substances to their patients and this was confirmed as a permanent measure in December 2020.
On commencement of the access programme clinicians and their patients can continue to avail of the licence pursuant to the Misuse of Drugs Acts 1977-2016.
