Michael Collins
Question:542. Deputy Michael Collins asked the Minister for Health if he will provide an update on the depletion of Rivotril 0.5 mg tablets (details supplied); and if he will make a statement on the matter. [9515/23]
View answerTuesday, 28 February 2023
Questions (542)
Written answers
Cheplapharm, the company responsible for supplying Rivotril 0.5mg tablets notified the Health Products Regulatory Authority (HPRA) of a shortage that began on 25th November 2022, due to a manufacturing issue. The HPRA has offered the company regulatory flexibility, including expediting controlled drug licences required to transport the product to Ireland and offering temporary authorisation for the company to import its product from another market to help mitigate the impact of this shortage on patients in Ireland. The HPRA has also engaged with the HSE regarding the shortage, as clinical treatment of patients is the remit of the HSE.
Whilst the HPRA has no role in procuring medicines, the HPRA has liaised with suppliers of exempt medicinal products (EMPs*) during the shortage, confirming that the HPRA has no objection to the supply of EMP alternatives and has assurances that there has been some EMP availability.
The issue has been discussed with all other European countries and the European Medicines Agency (EMA). The shortage also significantly impacts other European countries, including Spain, where the product is manufactured.
Cheplapharm has confirmed that the Irish stock has been released from the Spanish manufacturer and estimated that Rivotril would be resupplied to patients in Ireland during the week of 13th March.
Regarding Rivotril in liquid form, for clarity, there is no other formulation of Rivotril authorised in Ireland. There is, however, an alternative oral solution product from a different supplier with the same active ingredient, clonazepam, authorised and supplied in Ireland (Clonazepam Rosemount 0.5mg/5ml).
*Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations includes an exemption which enables practitioners to prescribe a medicine as an exempt medicinal product (EMP) under that practitioners direct responsibility, in order to fulfil the special needs of that specific patient. If a valid prescription is issued for an EMP in line with the above Regulations, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription.
As EMPs have not been granted a marketing authorisation in Ireland by the HPRA, they would not be assessed by the HPRA for quality, safety or efficacy. If sourced in response to a bona fide unsolicited order as a licensed product from another market these medicines will have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in that country carried out by the respective competent authority for medicines in that state.