Service Standards for Natural Health Product Application Reviews under the Natural Health Product Regulations

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 (NPN) or Homeopathic Medicine Number (DIN-HM), 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 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:

Service standards for the management of Product Licence Applications (PLA) for Natural Health Products (NHP)
Application Type Screening Process Full Assessment
Administrative Processing for Application Completeness Screening
These service standards apply to PLAs submitted using Natural and Non-Prescription Health Product Directorate (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
  • Compendial
  • Homeopathy Monograph
  • Class I Post-Licensing Change
April 1st to July 31st 2018
10 Business days
Not Applicable Not Applicable
August 1st 2018 to March 31st 2019
60 Calendar days
CLASS II
  • Non-Traditional
  • Traditional
  • Category IV/ Labelling Standard
  • Homeopathic Medicines with Non-Specific Claim
  • Class II Post-Licensing Change
April 1st to July 31st 2018  
10 Calendar days 20 Calendar days Not Applicable
August 1st 2018 to March 31st 2019
90 Calendar Days
CLASS III
(180 Calendar Days)
Footnote 1
  • Non-Traditional
  • Traditional
  • Homeopathic Medicines with Specific Claim
  • Class III Post-Licensing Change
10 Calendar days 20 Calendar days 180 Calendar days

Footnotes

Footnote 1

180 calendar days from successful completion of the screening process.

Return to footnote 1 referrer

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 2018 to 2019:

Annual service performance is measured over the course of the fiscal year (April 1 - March 31).

The HPFB's actual performance for all submissions received was:

Natural Health Products
Natural Health Products

Service Standard (%)

April to July 2018

Service Standard (%)

August to March 2019

Class I Product Licence Application or Amendment 28% 90.3%
Class II Product Licence Application or Amendment 32.8% 91.9%
Class III Product Licence Application or Amendment 86.8%

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: hc.nnhpd-dpsnso.sc@canada.ca
Facsimile: 613-960-8827
Teletypewriter: 1-800-465-7735 (Service Canada)

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