A leading nicotine replacement product is to be allowed on general sale for the first time, following a decision to relax the rule that has confined the availability of such products to pharmacies up to now.
The announcement by the Health Products Regulatory Authority (formerly the Irish Medicines Board) is likely to drive down the cost of anti-smoking aids as they become available in supermarkets and other retailers.
The decision by the authority to switch Nicorette nicotine replacement therapy (NRT) from “pharmacy only” status to “general sale” status followed an application from the manufacturer.
"This will be the first NRT product range available for general sale in Ireland, and will result in these products being more widely accessible by people wishing to seek assistance to reduce or quit smoking," the authority said. It is anticipated such products will become available on general sale in retailers from late August.
The decision does not affect the sale of electronic cigarettes, which is unregulated. The authority said where e-cigarettes are promoted as an aid to giving up smoking, they are considered to be a medicine requiring marketing authorisation. Where no medicinal claim is made, they fall outside the remit of the authority.
The authority has carried out an assessment of the safety and efficacy of several NRT products available in non-pharmacy outlets in other EU countries. “The switching of NRT products to general sale status is aligned with our policy to make healthcare products available at the most convenient point of access for people, where it is safe to do so,” said Pat O’Mahony, chief executive.
Stopping smoking
The products have been in use since the late 1970s and are a well-established treatment for smoking cessation, he pointed out. “We have reviewed supporting evidence and experience of NRT use. This includes experience of other EU countries and we are satisfied that it is appropriate to classify them for general sale in Ireland.” He said the change reflected increased public health awareness.
