Seán Crowe
Question:381. Deputy Seán Crowe asked the Minister for Health the licensed importers here for the anti-malarial drug mefloquine; and the licensed distributors here for mefloquine. [30387/16]
View answerTuesday, 18 October 2016
Questions (381)
Written answers
The marketing authorisation for Lariam (active substance, mefloquine) was withdrawn from the Irish market by Roche Products Ltd, the marketing authorisation holder, in July 2016. The reason Roche withdrew the authorisation was commercial. As the marketing authorisation for this product has been withdrawn in Ireland, the product information for Lariam is no longer available on the Health Products Regulatory Authority website.
Prior to withdrawing the authorisation, Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW United Kingdom was responsible for placing Lariam on the Irish market. Roche was also responsible for the distribution of the product in Ireland and could contract any wholesaler, authorised by the HPRA, to distribute it in Ireland on their behalf.
Although Roche does not market Lariam in Ireland now, it is possible for it to be sourced from another EU member state by an authorised wholesaler, to be supplied to the order of a prescriber, to meet the special needs of their patients. Products supplied in this way are known as ‘exempt medicines’ and are used under the direct responsibility of the prescriber. Any Irish authorised wholesaler that sources exempt medicines is required to notify the HPRA. Over the past three years there has been no notification to the HPRA of the sourcing of unauthorised (exempt) Lariam or other mefloquine containing product.
It is also possible for a prescriber to source an exempt medicine direct from an authorised wholesaler in another EU member state. In that event, there is no legal obligation on the wholesaler or the prescriber to notify the HPRA.
In relation to the request for the names of licensed importers of Lariam, the active substance in Lariam, mefloquine, is not controlled under the Misuse of Drugs Acts, so an import licence is not required for a medicine containing this substance.