Service Standards for Site Licence Application Review under the Natural Health Product Regulations

Disclaimer: Information on this webpage is provided for illustrative purposes only. The Natural Health Products Regulations should be relied upon for specific requirements, including if there are discrepancies between this page and the Natural Health Products 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).

The Natural Health Products Regulations ("the Regulations") contain requirements for the manufacturing, packaging, labelling, storing, importation, distribution and sale of natural health products (NHPs). These Regulations are intended to provide Canadians with ready access to natural health products that are safe, effective, and of high quality, while respecting freedom of choice and philosophical and cultural diversity. The Regulations are administered by Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD).

All businesses in Canada who wish to manufacture, package, label, or import natural health products for sale must hold a valid site licence.

A site licence gives the licensee the authorization to manufacture, package, label or import natural health products in Canada. These activities must be carried out according to the good manufacturing practices outlined in Part 3 of the Natural Health Product Regulations.

To learn more about how NHP site licence applications are managed by Health Canada, and to access the forms, please refer to the Site Licensing Guidance Document and the Site Licensing Forms respectively.

Service Standard:

The Health Products and Food Branch (HPFB) commits to issue a licensing decision within the service delivery standards outlined in the following table:

Service Delivery Standards
Application Type Administrative Processing or Application Completeness GMP Assessment and Decision Issuance
STREAM 1
Pre-cleared evidence for very site
(no limit on # of sites)
STREAM 2
Applications which include 1-9 sites and include a QAR as GMP evidence for one or more sites
STREAM 3
Applications which include 10 or more sites and include a QAR as GMP evidence for one or more sites

Site Licence:

  • SLA (new)
  • Renewal
  • Amendment

5 business days

30 business days

60 business days

Up to 90 business days

Foreign Site Reference Number (FSRN):

  • FS Registration
  • Yearly Update
  • Modification

5 business days

30 business days

60 business days

n/a

Notification
(SL and FSRN)

15 business 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 2018 to 2019:

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

Application Type GMP Assessment and Decision Issuance
STREAM 1
Pre-cleared evidence for very site
(no limit on # of sites)
STREAM 2
Applications which include 1-9 sites and include a QAR as GMP evidence for one or more sites
STREAM 3
Applications which include 10 or more sites and include a QAR as GMP evidence for one or more sites

Site Licence:

  • SLA (new)
  • Renewal
  • Amendment

90%

88.2%

81.3%

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)

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: