Refusal criteria applied to submissions for a site licence and foreign site reference number

NHP Site Licensing Bulletin No. 4, December 21, 2022, from the Natural and Non-prescription Health Products Directorate

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Purpose and scope

Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) continuously strives to increase process efficiencies. This applies to processing, screening and assessing SL and FSRN submissions.

This bulletin provides information on the types of deficiencies that will result in the refusal of a submission. Except where stated, these deficiencies apply to all SL or FSRN submission types filed with the directorate.

Submissions that do not meet the administrative needs and/or requirements of the Natural Health Products Regulations (NHPR), including section 28 (application requirements) and Part 3 (GMP) will be refused. Unless otherwise noted in the following sections, the NNHPD will not issue an information request notice (IRN) before refusing the submission.

Only sites with deficiencies will be refused, and not the entire submission, unless the site in question forms the basis of the SL (for example, the Canadian importer site). These include deficiencies identified during screening and GMP compliance deficiencies identified during assessment.

The objective of this bulletin is to encourage the submission of complete and high quality applications as they will:

Learn about submission deficiencies in section 3.1.3 of the Site licensing guidance document.

Refusal criteria (applied at screening)

SL and FSRN submissions

We will refuse SL and FSRN submissions based on the following criteria:

Other criteria upon which we will refuse an application also include the following:

IRN responses

We will refuse IRN responses based on the following criteria:

Risk-based GMP refusal criteria (applied at assessment)

GMP non-compliance will result in refusal.

Appendix 5 of the NHP Good manufacturing practices guidance document describes the risk classification of GMP observations. It also explains each risk category (risk 1 as critical, risk 2 as major and risk 3 as other or minor) within each GMP area (places, people, processes and products).

We will refuse SL and FSRN new applications, amendments and renewals (unless otherwise stated) based on the following criteria:


The SL and FSRN submission refusal criteria introduced in this bulletin will take effect on March 21, 2023.

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For inquiries about this bulletin, please contact us by email:

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