Natural Health Products Licensing
Simplify your NHP regulatory process with our expert solutions, streamlining your path to market.
Natural Health Products (NHPs) are intended to promote or maintain health for individuals. In order to sell NHPs in Canada (including online sales such as amazon.ca for example), they must be regulated under the Natural Health Products Regulations (NHPR). To be regulated, companies must obtain a product license called a Natural Product Number (NPN) by submitting detailed information on the product(s) to the Natural and Non-Prescription Health Products Directorate (NNHPD) governed by Health Canada. Once the NNHPD has approved the product as safe, effective and of high quality, an eight-digit NPN will be granted, and this number must appear on the front panel of the label.
NaturalSci Regulatory will take the burden off our client's shoulders and submit an NPN application (also known as a PLA, Product License Application) to NNHPD-Health Canada and correspond with the governing body until the NPN has been approved. With this being said, NHPs are divided into three different classes. The class of the product will dictate the review period from NNHPD-Health Canada.
Class I
The product attests to a single-ingredient monograph.
Class II
Product attests to multiple ingredient monograph.
Class III
One or more ingredients cannot attest to a Health Canada monograph and, therefore, require supplemental safety and efficacy data.
