Dáil Éireann Debate, Wednesday - 14 July 2021
424. Deputy Pauline Tully asked the Minister for Health if it will be ensured that a product which meets his Department's own clinical guidelines on the use of medical cannabis in epilepsy is added to the medical cannabis access programme before it is launched; and if he will make a statement on the matter. [31493/21]
View answerIn the Misuse of Drugs (Prescription And Control Of Supply Of Cannabis For Medical Use) Regulations 2019 (S.I. 262/2019) a "specified controlled drug" as defined can be used in the Medical Cannabis Access Programme and the definition outlines the specific requirements for those cannabis products or preparations.
A prospective supplier can apply to the Health Products Regulatory Authority (HPRA), on behalf of the Minister, to have a product considered for inclusion in the Schedule of ‘specified controlled drugs’ in the Regulations. As specified controlled drugs will fall under schedule 2 to the Misuse of Drugs Regulations 2017, a controlled drugs licence, processed by the HPRA, on behalf of the Minister, is also required for possession, supply or import of such cannabis products.
Details on how to apply for a licence to possess, supply or import medical cannabis products for use under the Medical Cannabis Access Programme in accordance with the requirements for schedule 2 products in the Misuse of Drugs Regulations 2017 can be found in the operator guidance issued by the HPRA.
It is open to any supplier or producer to apply to the HPRA to have their products assessed for inclusion in the programme.
