Dáil Éireann Debate, Thursday - 9 September 2021
1406. Deputy Richard O'Donoghue asked the Minister for Health if discussions are expected for the approval of a cannabis-based product (details supplied) owing to the fact that it is greatly helping many persons with epilepsy; and if he will make a statement on the matter. [42855/21]
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.
