Dáil Éireann Debate, Wednesday - 22 March 2023
245. Deputy Éamon Ó Cuív asked the Minister for Health if a medicine (details supplied) is currently on the GMS list of approved medicines; if so, if there is a shortage of supply of the medicine; the steps being taken to overcome this; and if he will make a statement on the matter. [14151/23]
View answerIn 2022, Cheplapharm, the company who supplies Rivotril, notified the Health Products Regulatory Authority (HPRA) of a shortage due to a packaging material issue. It lasted from 12 August and supply resumed on 7 October. The company confirmed that the product went out of stock again on 25 November, stating delays with the manufacturing production cycle, affecting many countries, including Spain, where the product is manufactured.
The HPRA has offered regulatory flexibilities on multiple occasions, including the possibility of authorising a batch of the product, initially intended for other markets, to be supplied to Ireland. The HPRA also offered to expedite any controlled drug licence and engage with our counterparts in other countries.
An alternative oral solution product from a different supplier with the same active ingredient, clonazepam, in oral solution formulation has been available. Given the increased demand observed with this product due to the Rivotril shortage, the HPRA has also facilitated regulatory flexibility by authorising product intended for a different country to be supplied to patients in Ireland. Throughout the shortage the HPRA has kept Epilepsy Ireland updated on the shortage.
Cheplapharm confirmed to the HPRA on Monday 13th, that 30,000 units of Rivotril (over four months’ stock) was en route to Ireland. Cheplapharm estimates that this product will arrive this week. Supply is expected to resume on the week ending 2 April.
I can also confirm that Rivotril is on the GMS reimbursement list
