Update On Medical Cannabis Products Approved For Use In Ireland Under Medical Cannabis Access Programme

Author:Mr Colin Kavanagh, Joanelle O'Cleirigh and Bridget McGrath
Profession:Arthur Cox

Medical cannabis is a rapidly developing area in the life sciences and healthcare sector in Ireland. In June 2019, regulations were introduced establishing the Medical Cannabis Access Programme (the "Access Programme").

The Regulations permit the importation, prescription and supply of certain cannabis products for a five year period under a pilot scheme. The initial phase involves the assessment of products for suitability for medical use. Importantly, it is intended that the HSE will reimburse approved products through the existing schemes.

Since our last update, available here, two medicinal cannabis products have been approved by the Minister for Health for use under the Access Programme:

Aurora High CBD Oil Drops, manufactured by Aurora Cannabis Inc.; and CannEpil, manufactured by MGC Pharmaceuticals. Companies who wish to have their cannabis-based product considered by the Minister for Health for inclusion in Schedule 1 of the Regulations must apply to the Health Products Regulatory Authority (the "HPRA"). The HPRA will only consider finished products, which require no further processing or manipulation for inclusion in the Access Programme. In order to apply for inclusion in the Access Programme, the product must satisfy the following criteria:

it does not have a marketing authorisation as issued by the HPRA under the national procedure; it is permitted to be sold or supplied for...

To continue reading