Dáil Éireann Debate, Wednesday - 18 April 2012
1184 Deputy Shane Ross asked the Minister for Health the reason a small pharmaceutical company (details supplied) in Dublin 14 was refused an application to the Irish Medicines Board to approve a switch from prescription only medicine to over the counter; and if he will make a statement on the matter. [18063/12]
View answer1233 Deputy Shane Ross asked the Minister for Health the reason the Irish Medicines Board has refused a designation to switch the drug Fluconazole from prescription to over the counter while under pharmacy supervision; and if he will make a statement on the matter. [18062/12]
View answerI propose to take Questions Nos. 1184 and 1233 together.
Medicines containing fluconazole currently marketed in Ireland are subject to prescription.
The criteria and procedures for authorisation of medicines and/or reclassification of medicines from prescription control to non-prescription are set out in EU and national legislation. The Irish Medicines Board (IMB) makes a determination on an application for authorisation of a medicine based on a scientific assessment of the application and data submitted by the applicant.
Every application for authorisation or reclassification is evaluated on a case by case basis, based on the merits of the data submitted.
In this particular case, I understand that communication between the Irish Medicines Board and the applicant is ongoing. Consequently, it would be inappropriate for me to comment on any particular application for authorisation or reclassification at this time.
