Dáil Éireann Debate, Thursday - 29 April 2021
107. Deputy David Cullinane asked the Minister for Health if an application has been received to add the PCBD110 product to the medical cannabis access programme; if so, when he expects a decision to be made on the addition of the product to the programme; and if he will make a statement on the matter. [22373/21]
View answerI have been informed by the Health Products Regulatory Authority that no application has been made from any prospective supplier looking to add PCBD110 to the Medical Cannabis Access Programme (MCAP).
Prospective suppliers of products to the Medical Cannabis Access Programme (MCAP) can apply to the Health Products Regulatory Authority (HPRA), acting on behalf of the Minister for Health, to have a cannabis product considered for inclusion in the schedule to the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019.
Applicants must provide evidence to demonstrate that the proposed cannabis product meets the requirements of a ‘specified controlled drug’ as defined in the MCAP legislation. The onus is on prospective suppliers to submit applications to the HPRA.
