Food supplements classified as Natural Health Products (NHPs) require prior market authorization to be sold in the Canadian marketplace. A Product License Application (PLA) must be submitted to Health Canada (HC)’s Natural and Non-prescription Health Products Directorate (NNHPD) to get approval for such products. Product licenses are issued for applications that meet the Regulatory requirements as outlined in the Natural Health Products Regulations (NHPR).
A product license assigns the Natural Product Number (NPN) or Drug Identification Number-Homeopathic Medicine (DIN-HM) to the product. NPN is an eight (08)-digit numerical code assigned to each NHP approved to be marketed under the NHPR, and the same should be mentioned on the product label’s Principal Display Panel (PDP). On the other hand, the DIN-HM is an eight (08)-digit numerical code assigned to each homeopathic medicine approved by HC.
There are three (03) classes of PLAs, which are differentiated from one another by their use of NNHPD monographs. Here are the classes, along with their HC review timelines:
- Class I – sixty (60) days.
- Class II – ninety (90) days.
- Class III – two hundred and ten (210) days.
The web-based PLA (or the web PLA) form is the main component of any NHP license submission package. Applicants are encouraged to carefully review their PLA submission package to ensure that all the necessary information has been provided. The following documents must be included in the submission package:
- Cover Letter.
- Web-based PLA Form.
- Finished Product Specifications (FPS) Form.
- Animal Tissue Form (ATF) (if applicable).
- Support Evidence(s) and/or Summary Report (Safety Studies Data) (if applicable).
- Designated Party Authorization (DPA) Form (if applicable).
- Letter of Access (if applicable).
To sum up, the PLA process plays a pivotal role in safeguarding public health in Canada by ensuring that all the NHPs sold in the market meet the highest standards of safety, quality, and efficacy.
Are you seeking further insights into the PLA process in Canada or Regulatory support for launching your NHPs in the Canadian market? Contact Freyr for expert assistance!