Nicorette patch reclassification
This article was originally published in The Tan Sheet
Executive Summary
The Medicines and Healthcare products Regulatory Agency seeks to reclassify the Nicorette 16-hour, 25 mg patches from Pharmacy (P) status to General Sales List (GSL) status, according to an April 9 notice. MHRA says it is in the public interest to encourage smokers to use nicotine replacement therapy and this means "allowing smokers as much choice of NRT products as possible, and for greater convenience, making those products as widely available as possible." MHRA also says the safety profile and abuse potential of Nicorette patch is "not significantly different from other NRT formats." The patient information leaflet contains instructions on how to use and safely dispose of the patch, "thereby addressing any potential for misuse," MHRA says. Comments are due to the agency by May 7...