December 8, 2015 Health Canada releases Policy and Monograph on Medicated Vapour products.
Health Canada’s Medicated Vapour Products Classification Decision
In December, Health Canada published a notice to the industry regarding the classification of medicated vapour products, such as those intended to provide relief from symptoms of colds, coughs and congestion via inhalation. The final decision as outlined in the published notice is that medicated vapour products will now be classified as drugs, and will fall into either the non-prescription or Natural Health Product (NHP) divisions of this category. It is important to note that the updated policy pertains to the active ingredients and not the delivery system, such as a vapourizer or a plug-in, through which some medicated vapour products achieve their effects. For products which use a delivery system, Health Canada has advised that the delivery system may be considered a medical device.
Additionally, if your medicated vapour product is pre-filled when purchased by the consumer, then it is considered to be combination drug-device product and will be regulated as either a drug, or a medical device depending on the principal mechanism of action by which the claimed effect of the product is achieved.
Natural and Non-Prescription Health Product Directorate’s Publication of Medicated Vapours Monograph
To ease the regulatory burden of filing a submission of an NHP medicated vapour product, the Natural and Non-Prescription Health Products Directorate (NNHPD) published a monograph. Products containing only camphor, menthol and/or eucalyptus are now eligible for expedited licensing if the product is to be used topically or via inhalation and marketed for the temporary relief of mild nasal congestion and cough associated with the common cold.
dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products. We can be reached at 1-866-647-3279 or firstname.lastname@example.org.