News Category: Regulatory news
The HPRA would like to draw marketing authorisation holders’ attention to the recent publication in the CMDh press release regarding the control of levels of pulegone and menthofuran in medicinal products.
These substances can be present as constituents of peppermint oil, mint oil or pennyroyal oil. New safety limits were adopted for these substances by the Committee on Human Medicinal Products (CHMP), based on a request from the Committee on Herbal Medicinal Products (HMPC) and after consultation with the Safety Working Party (SWP) at the European Medicines Agency.
MAHs for medicinal products containing pulegone and menthofuran, whether as constituents of the active substance or of an excipient, should now check whether their medicinal products comply with these exposure limits. A two-year timeframe for applicants to undertake regulatory action to bring products into compliance has been agreed at a European level. Work-sharing variations should be used where feasible.
Links to the CMDh press release and associated references are given below:
CMDh press release
CHMP May 2016 minutes (detail under item 14.3.3)
HMPC public statement