Format and structure of submissions for a site licence and foreign site reference number  

NHP Site Licensing Bulletin 3, December 21, 2022, from the Natural and Non-prescription Health Products Directorate

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Purpose and scope

When applying for a new site licence (SL), renewing an SL or amending an SL, there is a process to follow, in accordance with the Natural Health Products Regulations. This bulletin provides guidance on the appropriate process and criteria that applicants should follow. This will facilitate the review process and, by extension, help applicants meet the service standards set by the Natural and Non-prescription Health Products Directorate (NNHPD).

This bulletin also provides clarity on criteria that are considered significant administrative deficiencies, relating to format and structure. The types of deficiencies are defined in Section 3.1.3 of the Site licensing guidance document. The NNHPD will not issue an information request notice (IRN) before refusing the submission for administrative deficiencies. Refer to NHP Site licensing Bulletin No. 4 for information on other submission refusal criteria.

The criteria that will result in an immediate refusal are explicitly identified in this bulletin.

Further information on the submission process as well as the responsibilities and expectations for SL applicants/holders can be found in the following document:

Cover letter

Always include a cover letter with your submission.

Include the following information in your cover letter:

For renewals:

Reference where a response to any observations included in a previous issuance letter and, if applicable, in a Health Canada inspection exit notice (for example, drug or NHP good manufacturing practices (GMP) inspection) can be found. You may:

For a foreign site reference number (FSRN):

Note: As set out in NHP SL Bulletin No. 1, FSRNs that are not linked to an active importer are considered low priority and are not reviewed within NNHPD's current service standards. FSRN submissions that do not include the name of the importer associated with the submission are also treated as low priority.

For amendments with a pending licence renewal:

Note to reviewer:

Designated party authorization (DPA) form

Always include a DPA form with your submission when applicable.

Applicants and licence holders who have designated a third-party person to file a submission on their behalf must always submit a Designated Party Authorization (DPA) Form. Include this form with each submission and/or when the designated party changes.

The DPA form is necessary for anyone other than the senior official or the primary user as denoted in the trading partner agreement or profile, regardless of whether they are employed by the same company. This includes the application contact, the quality assurance person or anyone else who may be contacting the NNHPD about a submission. Only the contact name listed on the web SLA form will be contacted about the SL submission. Third parties identified on a DPA form will not be contacted outside of the relevant submission.

Failure to provide the DPA form (when applicable) is considered a significant administrative deficiency and will result in immediate submission refusal.

File format

Always apply these file formatting conventions.

All documents must be legible.

Original documents not written in 1 of Canada's official languages (English or French) must include complete, legible and high-quality translations.

Supporting documents included in your submission must be compatible with the NNHPD's IT systems. Always use the following format for files and documents:

Proceed as follows for a zip format:

The following are considered significant administrative deficiencies and will result in immediate refusal.

  • failure to provide documents that are legible
  • failure to provide documents in 1 of Canada's official languages
  • failure to provide documents in any of the acceptable file formats
  • failure to organize files individually

File naming and structure

Always apply the following guidelines and nomenclatures:

General guidance:

Recommended nomenclature:

Note: Standard operating procedures (SOPs) named in accordance with an internal control system are exempt from these conventions and should not be renamed. An example of a properly named file would be:

Table 1. Examples of terminology to use when naming files
Evidence type Document type Document name (if applicable)
  • QAR
  • SNC
  • SQAR
  • DEL
  • MRA
  • PICS
  • FDA
  • NSF
  • UL
  • SL
  • Form
  • Record
  • SOP
  • Template
  • Licence
  • Certificate
  • CAPA
  • Storage
  • Pest
  • Training
  • Sanitation
  • Testing
  • Release
  • Recall
  • Stability
  • Sterilization
  • Mother tincture
  • Potency
  • Raw material
  • Audit

Submitting supporting documentation

Only submit necessary information.

Examining superfluous information adds to the time it takes for NNHPD to process a submission, which has a negative impact on meeting service standards. Information that is deemed unnecessary or irrelevant to the SL submission are unrelated SOPs and certificates of analysis for products.

Provide only 1 piece of supporting GMP evidence for each site (for example, quality assurance report (QAR) form, drug establishment licence (DEL)). An exception would be if the evidence provided does not cover all of the licensable site activities or all of the changes to the SL being requested.

When a QAR form or a supplementary QAR form is submitted as GMP evidence, include only the SOPs and records/templates requested by the form (in other words, QAR questions 6, 9, 10, 11 and 14 or SQAR questions 5, 6 and 7). We may ask for additional information. This must be available upon request.

Product information

Always complete the product information section of the web SLA form.

Provide all relevant information to the product information section of the web SLA form. If there are many products, it may not be practical to include information on all of them. Applicants with 100 or more relevant products may append a product list to their submission. You must mention this in your cover letter and/or your note to reviewer.

In the web SLA form, you must still list all products for which documentation is submitted (for example, certificates of analysis, batch records, specifications) or that are referenced in the supporting documents. At a minimum, the web SLA form must list 1 product from each site that is performing licensable activities. Otherwise, you will receive an error message when trying to submit the form.


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

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