Update regarding changes to the classification of nicotine replacement therapy (NRT)

Notice type: Advisory

Date: 04/07/2014

The Health Products Regulatory Authority (HPRA). formerly the Irish Medicines Board,
wishes to inform you that a number of nicotine replacement therapy (NRT) medicines have recently been reclassified and have been authorised for sale in general retail and grocery outlets.


Product name or type:
Nicorette


Product Classification:
The Health Products Regulatory Authority (HPRA). formerly the Irish Medicines Board, wishes to inform you that a number of nicotine replacement therapy (NRT) medicines have recently been reclassified and have been authorised for sale in general retail and grocery outlets.

NRT medicines were previously available in pharmacies only and the HPRA's decision to reclassify NRT to permit general sale will result in these medicines being more readily accessible to people wishing to avail of assistance to reduce or quit smoking. It is anticipated that NRT medicines will become available in general retail outlets in Ireland later this year. The first products to be authorised will be from the Nicorette range.

Certain NRT medicines containing the active substance Nicotine are affected by the reclassification. A range of NRT medicines in various forms including transdermal patches, lozenges, gums, oral inhalers and oromucosal sprays have been reclassified.


Target Audience:
Healthcare Professionals


Background Information Or Related Documents:
NRT Reclassification DHPC


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