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

On this page

• At a glance
• Purpose and scope
• Cover letter
• Designated party authorization (DPA) form
• File format
• File naming and structure
• Submitting supporting documentation
• Product information
• Implementation
• Contact us

At a glance

• The NNHPD will begin refusing submissions that include the administrative deficiencies listed in this bulletin on March 21, 2023.
• Always include a cover letter with your submission.
• Always use a DPA form to designate a third-party filing on your behalf.
• Provide only necessary information, applying the file naming and formatting conventions.
• Always complete the product information section of the web SLA form.

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:

• Site licensing guidance document

Cover letter

Always include a cover letter with your submission.

Include the following information in your cover letter:

• administrative information such as licence type, submission type, company code, company name, licence number (if applicable), file number (if available)
• purpose of the application (for example, new application, adding a foreign site, renewal), which may be included in the subject line
• list of all supporting documents, including their specific file names (as per the recommended file naming convention outlined in this bulletin), for each site
• a clear description of any relevant background information (for example, details on mergers or acquisitions)

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:

• provide the responses separately as a corrective and preventive action (CAPA) plan
• list responses to observations in the order they appear on the SL issuance letter and/or inspection exit notice

For a foreign site reference number (FSRN):

• Indicate the active SL submission number or the name of the importer that is associated with the submission.

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:

• Indicate the licence renewal submission number (if known)

Note to reviewer:

• A document entitled 'Note to Reviewer' may be included to highlight any important information regarding the submission. It is our intention to add a 'Note to Reviewer' field in a future update to the web SLA form.

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.

File format

Always apply these file formatting conventions.

All documents must be legible.

• For example, ensure any scanned documents are clear and legible.

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

• A certified translation is recommended to avoid processing delays or potential submission refusal.

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

• zip, pdf, doc, docx, xls, xlsx and jpeg
  • jpeg files will only be accepted when providing photographic evidence of the physical site itself
• supporting documents must be submitted in a submission package
  • submission package to be organized individually as per the web SLA documentation checklist and not as a single undivided file

Proceed as follows for a zip format:

• A zip file should only consist of 2 folders named 'Correspondence' and 'Evidence'.
• In the 'Correspondence' folder include the cover letter, note to reviewer (if applicable), web SLA form and DPA form.
  • All other files are to be placed in the 'Evidence' folder.
• Zip folders within zip folders should not be used.

Always apply the following guidelines and nomenclatures:

General guidance:

• file names must be in 1 of Canada's official languages (English or French)
• file names should not have more than 70 characters

Recommended nomenclature:

• Web SLA form: the filename is automatically generated upon completion, and must not be changed
• Cover letter: "YourCompanyName_CoverLetter_YYYY-MM-DD"
• Note to reviewer: "YourCompanyName_NoteToReviewer_YYYY-MM-DD"
• DPA form: "DPA_PersonFirstName_PersonLastName_YYYY-MM-DD"
• Good manufacturing practices (GMP) evidence documentation:
  "SiteName_EvidenceType_DocumentType_DocumentName"
  • Short forms for company and site names are acceptable, especially when 2 or more sites share the same name.
  • Table 1 lists terminology on evidence type, document type and document name.
  • If more than 1 document has the same name based on the suggested nomenclature, add a numerical value after the document name (for example, "YourSiteName_SNC_Record_Stability1").
  • If a document applies to a specific product (for example, stability record), include the 8-digit natural product number (NPN) or homeopathic medicine number (DIN-HM) (as listed in the Licensed Natural Health Products Database) at the end of the file name by adding "_NPNnumber".

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:
"NHPinc_NSF_Record_Testing_80000000".

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 FSRNA 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.

Implementation

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

Contact us

For inquiries about this bulletin, please contact us by email: nnhpd-dpsnso@hc-sc.gc.ca.