Service Standards for Natural Health Product (NHP) Application Reviews under the Natural Health Product Regulations – Health Canada
Disclaimer: Information on this webpage is provided for illustrative purposes only. The Natural Health Product Regulations should be relied upon for specific requirements, including if there are discrepancies between this page and the Natural Health Product Regulations.
Service Description:
Health Canada posts service standards and performance information for services with over 100 regulatory authorizations, such as permits or licences, issued each year (high-volume regulatory transactions).
This service is a high-volume regulatory transaction used by applicants seeking a licence. All natural health products must have a product licence before they can be sold in Canada. To get a licence, applicants must provide detailed information about the product to Health Canada, including: medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s).
Once Health Canada has assessed a product and decided it is safe, effective and of high quality, it issues a product licence along with an eight-digit Natural Product Number or Homeopathic Medicine Number, which must appear on the label. This number lets you know that the product has been approved by Health Canada.
To learn more about how NHP applications are managed by Health Canada, please refer to the Management of Product Licence Applications (PLA) For Natural Health Products Policy. Product licensing forms can be found on the Product Licensing Forms and Templates page. A map of the licensing process for natural health products can be found on the Licensing Process Map page.
The Natural Health Products Regulations ("the Regulations") contain requirements for the manufacture, packaging, labelling, storage, importation, distribution and sale of NHPs. The Regulations are administered by Health Canada's Natural and Non-Prescription Health Product Directorate (NNHPD). Health Canada is committed to balancing the desire of Canadians for a broader range of self-care choices with the need to ensure that appropriate safety and quality standards are in place.
Service Standard:
The Health Products and Food Branch (HPFB) commits to issue a product licensing decision within the service delivery standards outlined in the following table:
| Application Type | Screening Process | Full Assessment |
|---|---|---|
| These service standards apply to PLAs submitted using NNHPD's electronic PLA form. Applications submitted using a different format will be assessed within Footnote 1 180 calendar days following the screening period. | ||
CLASS I
|
60 Calendar days | Not Applicable |
CLASS II
|
90 Calendar Days | Not Applicable |
| CLASS III (180 Calendar Days) Footnote 1
|
30 Calendar Days | 180 Calendar days |
|
||
Performance Target:
The target for achieving these standards is set at 90% of submissions being completed within the applicable review timelines.
Performance result in fiscal year 2020 to 2021:
Annual service performance is measured over the course of the fiscal year (April 1 - March 31).
In fiscal year 2020-2021, due to the COVID-19 pandemic and the need to significantly increase the supply of hand sanitizers in response to public health measures, NNHPD licensed 4,263 hand sanitizers and issued 2,053 temporary COVID site licences. These applications were prioritized, which meant that Health Canada could not meet its performance standards for non-COVID related NHP applications.
The HPFB's actual performance for all submissions received was:
| Natural Health Products | Percentage (%) within Service Standard |
|---|---|
| Class I Product Licence Application or Amendment | 70.5% |
| Class II Product Licence Application or Amendment | 50% |
| Class III Product Licence Application or Amendment | 31.5% |
Departmental Contacts:
Natural and Non-prescription Health Products Directorate
Health Products and Food Branch
Health Canada
250 Lanark Avenue
Address Locator 2002B
Ottawa, Ontario
K1A 0K9 (Canada Post delivery including Xpress Post)
K1Z 1G4 (Courier service excluding Xpress Post)
NOTE: Please note this e-mail account does not have secure transmission capabilities. We therefore ask that you do not include or attach sensitive information (for example, product formulations and applications) to your message. Should you nevertheless transmit sensitive information through this account, Health Canada will not be liable for any damages that may arise as the result of interception, loss, theft of the information or other action or difficulty.
E-mail: nnhpd-dpsnso@hc-sc.gc.ca
Facsimile: 613-960-8827
Teletypewriter: 1-800-465-7735 (Service Canada)
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