Harmonized Site Licence and FSRN Harmonized Application Form (Web SLA) Guidance

Table of Contents

Recommendations for optimal results

Following the recommendations below will ensure the best possible outcome when using the Web SLA form.

Meet the system requirements and enable JavaScript

While the Web SLA form will function in most browsers, for best results, we recommend using either Firefox 54+ or Chrome 60+. The Web SLA form also requires you to have JavaScript enabled in your browser. When JavaScript is disabled the form will malfunction, e.g. buttons and text fields will be disabled and the French version will be missing some French text. Click on enable JavaScript to find the instructions specific to your browser. If you have concerns with making these changes to your security settings, consult with your IT security advisor first.

Use the Help links to access the help text while filling out the Web SLA form

Every page of the form will have a Help link. Clicking on the link will open the help page corresponding to the section of the web form you are on. While on the help page, you can scroll up and down to continue reading, or select index to navigate to a list of all sections of the user guide. To exit the help page and return to the form, you can click anywhere outside the help text or click the Esc (escape) key on your keyboard.

Save your progress — sessions will timeout

The Web SLA form may be saved at any time on your workstation and resumed at a later time by loading the saved HTML into the form. During an active session, any data you enter in the form will be temporarily retained. However, after 29 minutes of inactivity your session will timeout and any unsaved progress will be lost. A timeout warning will pop up 5 minutes before the actual timeout. Clicking on "Continue session" will refresh the timer. If you are unable to continue with your session, please remember to save your progress prior to exiting the application by clicking on "Save file".

Furthermore, to save your progress on a specific page of the Web SLA, you must hit "Continue", otherwise the work will not be saved.

Allow web pages to refresh before continuing

If you begin to make selections and enter information before the web page has fully refreshed, the information will be lost. Depending on your internet speed it might take several seconds for the web page to refresh. To prevent entering the same information twice, allow the web page to refresh before continuing.

Validate as you go

The Web SLA is continually applying form validation rules to ensure that the information being captured is as accurate and complete as possible. Where applicable, always select the "Continue" button to validate the content of a page before moving onto the next section. Where information is incorrect or where a required field has not been filled, an error message will appear above the page indicating which field has missing or incorrect information. An error message highlighted in red will also display above the field(s) causing the error. You may click on the error message or scroll through the page to access the field(s) to be revised. Be sure to review the entire page and correct each instance before selecting the "Continue" button again. The form will not finalize until these fields are completed correctly. If the page does not have a continue button, then click the "Next" button to move to the next section of the form.

Note: For all Natural and Non-prescription Health Products Directorate (NNHPD) forms, required fields are indicated by a red asterisk (*) before the field label and the word "(required)", after the field label.

Use the form's navigation features

The Web SLA has several navigation features that are consistent across the entire form. During an active session, it is highly recommended to use the Web SLA's navigation features rather than the browser's forward and back buttons, which can result in unpredictable form behaviour.

  • Table of contents: The table of contents can be accessed from the top right of the Web SLA form. It identifies the main sections of the form and allows you to move between them. Use the table of contents if the form doesn't automatically flow to the next section of the form.
  • Save file: To save your progress or to create a template, select "Save file" to save a copy of the Web SLA form to your local drive. The file will be saved in HTML format. You may be prompted to save the file to a specific location, or the file may save automatically to your default download folder. To reopen and continue working on a saved session, select "Load submission from file" from the Web SLA landing page, locate the .html file on your local drive, and select "Load data".
  • Exit: Selecting "Exit" during a session will bring you back to the Web SLA form landing page and erase any data from that current session. Only select this option to start a new form without finalizing/saving the current form, or after saving a copy of the current form to your local workstation.

Selecting License Type

The Web SLA form is divided into two pathways: Site Licence and FSRN. Select the licence type for which a submission will be sent to the NNHPD. Note that as the form is highly dependent on this selection, returning to this page and changing licence type will delete all other information already entered in the form.

Application Information

General information about the application is collected on the Application information page. This includes the application type, the site licence number or FSR number, whether a SL was held by the applicant in the past and a description of the notification (if applicable).

The application type selected in the Application Information section determines the layout and behaviour of the Web SLA.

Site licence applications

Application types

The available types of applications are as follows:

  • New site licence application: a new application for a site licence. This application type applies to companies wishing to conduct licensable activities with NHPs that have never held a SL before or companies which had their previous SL cancelled, suspended or refused.
  • Site licence amendment: An amendment is required for one or more of the following changes to a Site Licence: Adding a new activity or category to an already licenced site, adding a new building for manufacturing, packaging, labelling or storage, adding a new foreign site to an importation Site Licence and changing the address of an already licenced site. Whenever possible, it is recommended that multiple amendments to the site licence be made within one application to the NNHPD, rather than multiple separate applications. However, changes to a site are not authorized until the amendment application has been completed and an updated Site Licence issued.
  • Site licence change notification: A notification to the NNHPD is required within 60 calendar days after a change in any of the following information contained on an applicant's original submission: Change in Licensee information, Change in senior official information, Change in contact information, Change in QAP information, Changes to Building that do not meet the definition of an amendment to a SL, Changes to Practices/Procedures, Changes to Equipment.
  • Site licence renewal: A SL holder must renew their Site Licence at least 30 days prior to its expiry date in order to obtain authorization to continue conducting the activities authorized on their existing SL. The Site Licence must be renewed as follows: Every year, when the licensee has held the licence less than three years from the date of issuance, every two years, when the licensee has held the licence for a period of at least three years from the date of issuance but less than nine years, every three years, when the licensee has held the licence for nine years from the date of issuance or more. All applicants must submit their application a minimum of thirty (30) days prior to the expiry date of the Site Licence. Furthermore, companies who have not conducted activities in the 12 months prior to filing their application for site licence renewal (regardless of the renewal cycle), and who do not have records demonstrating their ability to comply with Good Manufacturing Practices (GMP), will see their application for renewal refused. A new application will be required prior to initiating or resuming activities.

Site licence Number

Should the application type be an amendment, renewal or notification, provide the site licence number linked to the applicant's site licence. This is a 6 digit number assigned to each site licence. This number begins with a "3" and is found on issued site licences.

Expired site licence

Companies who have failed to submit their site licence renewal (regardless of the renewal cycle) 30 calendar days prior to the Site Licence's expiration date will see their application for renewal refused. A new application will be required prior to initiating or resuming activities. If you previously held a site licence that expired, or was cancelled, select "Yes" in this field.

Cancelled, Refused or Suspended site licence

If your previous licence was cancelled, suspended or refused, evidence that outstanding deficiencies have been resolved is required. This 6 digit number begins with a "3" and is found on issued site licences. If "Yes" was selected in the previous field or the situations described prior apply to the applicant, the previous site licence number must be entered.

Description of notifiable changes to Site Licence

Should the application type be a notification, provide a description of the changes made to a licenced building, changes to practices/procedures and/or changes to equipment. Notifications will be examined for completeness, as a result, be sure to include as much detail as necessary for the review of the change to be performed by the NNHPD.

Foreign Site Reference Number Applications

New FSRN Applications

New FSRN applications will be considered a lower priority for review until further notice.

NOTE: FSRN applications that are linked to an importer's active submission will be assessed at the time of reviewing the importer's site licence application.

Renewals for FSRN applications that relied on pre-cleared evidence

FSRNs meeting all two (2) criteria below will have the validity period extended until further notice.

  1. The foreign company has been inspected by regulatory/qualified authorities within the last 5 years; and

  2. There have been no risk issues flagged by a recognized jurisdiction (e.g. US FDA Warning Letter).

Therefore, FSRN holders meeting the criteria above are not required to submit a renewal for the FSRN.

Note that, Health Canada should be notified if there is a change to the GMP of the facility, which could present a risk to health, including, but not limited to a non-compliant rating from regulatory/ qualified authorities and/or other regulatory action (e.g., Warning letter).

Renewals for FSRN applications that relied on a SNC/QAR as evidence of GMP compliance AND are linked to an active importer

FSRNs (with an expiry between 2020-2021) that were issued based on a SNC/QAR as evidence of GMP compliance will have the validity period extended until March 31, 2022, with the potential for further extension dependent on the pandemic situation. Therefore, FSRN holders are not required to submit a renewal for the FSRN until the extension period has passed.

Note that, Health Canada should be notified if there is a change to the GMP of the facility, which could present a risk to health, including, but not limited to a non-compliant rating from regulatory/qualified authorities and/or other regulatory action (e.g., Warning letter).

In general:

  • Each foreign site that is linked to an importer's active submission will be assessed at the time of reviewing the importer's renewal application to ensure there is no new or active risk issue with the foreign site(s).

  • An FSRN application that is not linked to any importer will not be prioritized for review.

  • A new Notice of Acceptance (NOA) will not be issued.

Application types

The available types of applications are as follows:

  • New foreign Site Reference Number: a new application for a FSRN. This application type applies to foreign companies wishing to obtain a FSRN indicating that the foreign site is found to be in compliance with Part 3, GMP, of the NHP Regulations.
  • Foreign Site Reference Number Modification: an amendment or notifiable change to an existing FSRN. FSRN amendments consist of the following and must be supported by evidence of GMP compliance: adding a new activity, relocation of a site (change of address). An FSRN notification, on the other hand, must be submitted to the NNHPD within 60 calendar days of implementation and consists of the following: a change in the name, mailing address, telephone number, fax number, e-mail address, building, equipment, practices or procedures.
  • Foreign Site Reference Number GMP Update: In order to maintain the status of a FSRN, the applicant must submit a renewal application in sufficient time to the NNHPD. A FSRN will expire one year after the date of issuance if a Quality Assurance Report(QAR) was provided as GMP evidence. A FSRN will expire three years after the date of inspection if pre-cleared GMP evidence was provided.

Applicant or licensee

The Applicant or licensee page captures information about the company in whose name the site licence or FSRN is to be registered (the applicant will be referred to as the licensee once a licence or reference number has been granted). The Company name, Company code, Street, City and Country are required in all cases. The Province/State and the Postal/ZIP Code are also required. Postal/ZIP codes must be displayed in the appropriate format (X#X #X#, X#X#X#, or #####, where X represents a letter and # a number). After the information has been entered, select the "Continue" button to save and navigate to the next section of the form.

Businesses that do not require a site licence

  • A pharmacist, aboriginal healer, traditional Chinese medicine practitioner, or health care practitioner, who, at the request of a patient, compounds a NHP for the purpose of sale solely to that individual. For clarification on what activities performed by a practitioner requires a site licence, refer to the Natural Health Product (NHP) Compounding Policy.
  • Distributors that do not import NHPs into Canada. A distributor is a person who sells NHPs to another person for the purpose of further sale in Canada. However, distributors must follow GMP (as stated in section 43 (1) of the Regulations).
  • Persons (business or individual) performing the activities of growing, harvesting, cleaning, sorting, and/or importing raw material but do not produce a product that is ready for use or consumption by the consumer. For further clarification on how the NNHPD defines a raw material, refer to the Natural Health Product Raw Material Policy. Persons (businesses or individuals) that invoke section 37 of the Food and Drugs Act, to manufacture NHPs for the sole purpose of exporting outside of Canada as per the Import and Export Policy for Health Products under the Food and Drugs Act and its Regulations.
  • Persons (businesses or individuals) that manufacture, package, label, or import NHP's solely for the purpose of a clinical trial as per section 26 of the Regulations. However, the products and activities must conform to the provisions outlined in Part 4 of the Regulations (Clinical Trials Involving Human Subjects). For more information on clinical trials, including GMP, see the Clinical Trials for Natural Health Products guidance document.
  • Testing labs do not require a site licence. However, it is expected that the activity which is required to confirm that a NHP meets its finished product specifications be conducted in a manner that assures accurate and valid results.

Form Language

The language used to fill the site licence application form. Once the applicant or licensee page is confirmed, the language cannot be changed, except by using the New Application button. The available options are English or French.

Licence Type

The available types of applications are as follows:

  • Site Licence: A site licence is required for the physical site in Canada where any persons (business or individual) wish to manufacture, package, label, and/or import a NHP for sale.
  • Foreign Site Reference Number: A FSRN is issued to a manufacturer, packager and/or labeller of NHPs located outside of Canada, referred to as a foreign site. The reference number issued is not a site licence or authorization for direct export of NHPs into Canada, but rather, a unique reference number. The FSRN holder will engage in a partnership with a licensed Canadian importer in order to export NHPs into Canada.

The licence type selected in the Application Information section determines the layout and behaviour of the web SLA.

Company Name

This is a free form text field in which the applicant is to indicate the full legal name of the applicant or company applying for a site licence. Do not abbreviate applicant/company name.

Company Code

The company code is a unique five digit code which is assigned to an individual company by the NNHPD. On the Applicant/Licensee page, the company code must be the one assigned to the applicant/licensee. Do not use a third party contact's company code on this page as this will cause a delay in the processing of your submission and may result in the rejection of your application. If you do not have a valid applicant/licensee company code, please submit a request via the email address (nnhpd-dpsnso@hc-sc.gc.ca) and indicate "Request for a company code" in the subject line. In the body of the email please include the same company contact information you will be using to complete your web SLA form such as company name, address, and senior official.

Company Mailing Address

Provide the full mailing address of the applicant/company identified in the company name field. If a suite/unit number is used, provide the suite/unit number in addition to the street and street number, the city/town, the province/state and the postal code/zip code.

Should the application be for a site licence, the country will be locked to Canada in the "Country" field.

Postal/ZIP codes must be displayed in the appropriate format (X#X #X#, X#X#X#, or #####, where X represents a letter and # a number).

Contact Information

The contacts table automatically includes a row for each required contact person: senior official, application contact and quality assurance person (if applicable). One of the SL application contacts must be physically located in Canada and will be held responsible for the quality of manufactured, packaged, labelled and/or imported NHPs, as applicable. To input or modify contact information, select the "Modify" button next to the corresponding contact. On the next page, input all required contact information and select the "Continue" button to return to the contact information table.

Senior Official

A senior official must always be designated for the applicant company. This principal contact for the applicant, at the address given, is the person to whom regulatory mail is sent. This is not the contact for site licence application-specific questions, but rather the person who represents the company. This individual should be a senior person in the company such as the Chief Executive Officer or a director. In some cases, especially small businesses, one person may be indicated as senior official and contact for the application. If the senior official of the applicant company changes, the NNHPD must be notified of this change in writing by completing a Site Licence Notification or FSRN Update.

Language preferred

The preferred language of the Senior Official. The language selected will dictate the language used for all regulatory mail, including the site licence.

Senior Official Contact Information

The information needed to contact the senior official: the full mailing address, telephone number, fax number (if available) and e-mail address. The full mailing address is not required if the Senior Official is located at the same address as the applicant company indicated in the Applicant or Licensee page.

Postal/ZIP codes must be displayed in the appropriate format (X#X #X#, X#X#X#, or #####, where X represents a letter and # a number).

Phone and fax numbers must be entered in the appropriate format (regional code (###)-###-####, for Canada and United States, where # represents a number).

Email addresses must be entered in the appropriate format (X#@X#.XXX, where X represents a letter and # a number. X# represents a combination of letters and numbers of varying length).

Contact for this application

The contact for this application is the person to whom the NHPD will direct site licence application-specific questions. This may be an employee of the licensee/applicant, or an individual contracted from another company on behalf of the applicant (for example, a consultant). If the contact for this application is also the senior official for the company, select yes in "contact same as Senior Official" and this section will be auto-completed.

Language preferred

The preferred language of the contact for this application. The language selected will dictate the language used for communication related to this application.

Contact for this Application Contact Information

The information needed to contact the contact for this application: the full mailing address, telephone number, fax number (if available) and e-mail address. The full mailing address is not required if the contact for this application is located at the same address as the senior official.

Postal/ZIP codes must be displayed in the appropriate format (X#X #X#, X#X#X#, or #####, where X represents a letter and # a number).

Phone and fax numbers must be entered in the appropriate format (regional code (###)-###-####, for Canada and United States, where # represents a number).

Email addresses must be entered in the appropriate format (X#@X#.XXX, where X represents a letter and # a number. X# represents a combination of letters and numbers of varying length)"

Quality Assurance Person

The individual who is responsible for assuring the quality of the NHP before it is made available for sale. This person should be qualified by education, training and/or experience relating to the specific activity (i.e. manufacturing, packaging, labelling and/importing). If the Quality Assurance Person is also the contact for this application, select yes in "QAP same as contact for this application" and this section will be auto-completed.

Quality Assurance Person Contact Information

The information needed to contact the Quality Assurance Person: the full mailing address, telephone number, fax number (if available) and e-mail address. The full mailing address is not required if the Quality Assurance Person is located at the same address as the contact for this application.

Postal/ZIP codes must be displayed in the appropriate format (X#X #X#, X#X#X#, or #####, where X represents a letter and # a number).

Phone and fax numbers must be entered in the appropriate format (regional code (###)-###-####, for Canada and United States, where # represents a number).

Email addresses must be entered in the appropriate format (X#@X#.XXX, where X represents a letter and # a number. X# represents a combination of letters and numbers of varying length)"

Site Information

General information about the sites conducting licensable activities is collected on the Site information page. This includes the building information, Quality Assurance Person information for the site(s), changes to an existing site (if applicable), information on the activities conducted at the site(s) for specific categories of products and the GMP evidence to be used for the site(s).

Canadian site(s)

This is the building (or buildings) where licensable activities (manufacturing, packaging, labelling, importing and/or storage of NHPs) are performed in Canada. Only include Canadian sites implicated in the application, meaning for:

  • New applications: List all Canadian sites that are proposed to conduct licensable activities following the issuance of the site licence.
  • Amendments: List only the Canadian sites to be amended or added. Do not include other sites that are already on your licence as the link between the site licence holder and the amendment to their site licence is already made in the Applicant or Licensee page.
  • Renewals: List all Canadian sites authorized to conduct activities on the previous site licence that are to be renewed. Should sites need to be removed from the Site Licence at renewal, do not list them as Canadian sites under this application and they will be removed following the review of the renewal. New sites, or changes to existing sites, will not be added at renewal.

Company Name

This is a free form text field. Enter the full name of the building conducting licensable activities with natural health products. Do not abbreviate company name.

Address

Provide the full address of the building identified in the building address field. Do not enter a P.O. Box or mailing address, enter the address of the building where activities are conducted. If a suite/unit number is used, provide the suite/unit number in addition to the street and street number, the city/town, the province and the postal code.

Postal/ZIP codes must be displayed in the appropriate format (X#X #X#, X#X#X#, or #####, where X represents a letter and # a number).

Dwelling house

Indicate if the proposed site is a place of residence.

Quality Assurance Person for this Site

The individual who is responsible for assuring the quality of the NHP before it is made available for sale. This person should be qualified by education, training and/or experience relating to the specific activity (i.e. manufacturing, packaging, labelling and/importing).

Phone and fax numbers must be entered in the appropriate format (regional code (###)-###-####, for Canada and United States, where # represents a number).

Email addresses must be entered in the appropriate format (X#@X#.XXX, where X represents a letter and # a number. X# represents a combination of letters and numbers of varying length)"

Changes to this site

This section is used to describe changes to a site during an amendment application. Select only those that apply. This section opens for completion solely if "Amendment" or "Notification" was selected as the Application Type.

  • Name/Address: Select if the building entered in this section has gone through a name change or changed addresses. Select this option only for changes to a site already on the company's site licence.
  • QAP Information: Select if the QAP information for the building entered in this section has changed.
  • Activities: Select if the approved activities for the building entered in this section are to be changed. Select this option only for changes to a site's activities already on the company's site licence.

Storage/Warehouse only

Select "YES" if the building will be used for warehousing/storage only, in which case indication of additional activities will not be necessary for this site. Storage and warehousing refer to a site, also called a warehouse, whose main purpose is to hold natural health products.

Activity Types

The available activity types are as follows:

  • Manufacturing: Refers to a person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of the patient, compounds a natural health product for the purpose of sale to that patient.
  • Packaging: Refers to a person who puts a finished natural health product in its immediate container. Not to be confused with secondary packaging, defined as placing an NHP in its immediate package/container into a secondary package/container, which under the Natural Health Products Regulations, is considered labelling of NHPs. A site conducting solely secondary packaging should select solely "Labeller" as activity type.
  • Labelling: Refers to a person who affixes the inner or outer label of the natural health product. A label is defined as including any legend, word or mark attached to, included in, belonging to or accompanying any Natural health product. Note that secondary packaging, defined as placing an NHP in its immediate package/container into a secondary package/container, is considered labelling of NHPs under the Natural Health Products Regulations. A site conducting solely secondary packaging should select solely "Labeller" as activity type.
  • Importing: Refers to a person who imports a natural health product into Canada, for the purpose of sale. This would also include bulk natural health products. Selection of this activity type will open the "foreign site(s) information" fields on this page. Information on the site(s) from which product(s) are to be imported should be included in that section.

Categories of products

The available categories of products are as follows:

  • Non-sterile: Refers to a natural health product, a substance set out in Schedule 1 of the Natural Health Products Regulations or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, that is not defined as a sterile or homeopathic product.
  • Sterile: Refers to products manufactured, packaged, labelled or imported in a dosage form that is free from viable microorganisms. Should sterile activities be selected, sufficient GMP evidence to demonstrate compliance with sections 59 and 60 of the Natural Health Products Regulations must be provided along with the required GMP evidence for this site.
  • Homeopathic: Refers to medicines that are manufactured from or contain as medicinal ingredients only those substances or sources referenced in The Homeopathic Pharmacopoeia of the United States (HPUS), the Homöopathische Arzneibuch (HAB), the Pharmacopée Française (PhF) or the European Pharmacopoeia, as amended from time to time, and that are prepared in accordance with these pharmacopoeias. Should homeopathic activities be selected, a Supplementary Quality Assurance Report (SQAR) must be provided in addition to a QAR as this form covers all the additional GMP requirements for homeopathic medicines as outlined in Appendix 1 of the GMP guidance document.

Note: if this is a renewal, only activities authorized in the most recent issuance of the licence will be renewed. Changes to activities should be done by submitting a site licence amendment.

GMP Evidence for Canadian sites

The acceptable GMP evidence to provide for this site is dependent on the Application Type selected in the previous section of the form, therefore some types of evidence listed below may not be shown as an option. Select the GMP evidence to be provided for this site:

  • Quality Assurance Report: The QAR form is a report prepared by the quality assurance person responsible for the site, who has the training, experience and technical knowledge relating to the activities conducted and the requirements of Part 3, GMP, of the Regulations. This report is based on the assessment against the GMP requirements set out in the GMP guidance document. The QAR is considered to be an attestation by the applicant that the site meets all the requirements of Part 3, GMP, of the Regulations. A QAR is valid for a period of one year from the date of completion by the quality assurance person. Only acceptable as evidence for new applicants that never held a licence previously, or if adding a new site to an existing site licence.
  • Supplementary Quality Assurance Report : Manufacturers of NHPs used in homeopathy must complete and submit this form in addition to the standard QAR. This form covers all the additional GMP requirements for homeopathic medicines as outlined in Appendix 1 of the GMP guidance document. The SQAR is valid for a period of one year from the date of completion by the quality assurance person. Only acceptable as evidence for new sites that will conduct activities with homeopathic products.
  • Summary of Net Changes (SNC): A report prepared by the quality assurance person responsible for the site, who has the training, experience and technical knowledge relating to the activities conducted and the requirements of Part 3, GMP, of the Regulations. This report allows the applicant to identify changes to the site which have occurred since the QAR was provided. The SNC is considered to be an attestation by the applicant that the site meets all the requirements of Part 3, GMP, of the Regulations. Copies of completed records from within the last 12 months are required along with the SNC form. Though the NNHPD may request additional records based on the totality of information provided and the assessment conducted, one record is required for each section per site. If there have been changes to the building(s), practice(s) and procedure(s), you are also required to complete and submit the relevant section(s) of the QAR form or provide another form of acceptable GMP evidence to support the change(s). The SNC is valid 1 year from date of completion.
  • Drug Establishment Licence (DEL): DEL holders may submit a copy of their current DEL demonstrating compliance with the requirements of part C, divisions 2 to 4 of the Food and Drug Regulations (FDR). The DEL lists all buildings where activities are authorized for drug products under the FDR. By submitting a DEL, the site licence applicant is attesting to following the same standards for NHPs as for drugs. The DEL holders must submit alternate evidence of GMP compliance for those additional NHP related activities and building addresses that were not inspected and are not listed. The DEL remains valid GMP Evidence so long as the DEL is active.
  • GMP Certificate from a Qualified Authority: A qualified authority is an authority member from a country where Health Canada has a Mutual Recognition Agreement (MRA) regarding GMP for drug products, or an authority member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) regarding GMP for drug/human medicinal products. A list of PIC/S members can be found on the PIC/S website and a list of MRA authorities can be found on the Health Canada website. The certificate must cover all the NHP related activities, equipment and buildings at the site and must be provided in one of Canada’s official languages. A certificate from a qualified authority is valid for a period of three years from the date of the inspection.
  • NSF Standard 173 section 8 Certificate: NSF International Standard 173, Section 8 for Dietary Supplements Certificate has been found to partially cover the requirements of Part 3, GMP, of the Regulations and may be submitted in support of a site licence application along with additional supporting information. Specifically, this standard does not include equivalent requirements related to testing as indicated in Part 3 of the Regulations. Therefore, along with the inspection report and corrective actions, section 44 (finished product testing) and 52 (stability) information are required. The report must cover all the NHP related activities, equipment and buildings at the site. The NSF audit is valid for a period of three years from the date of the audit.
  • UL Report: UL Report has been found to partially cover the requirements of Part 3, GMP, of the Regulations and may be submitted in support of a site licence application along with additional supporting information. Specifically, this standard does not include equivalent requirements related to testing as indicated in Part 3 of the Regulations. Therefore, along with this evidence type, section 44 (finished product testing) and 52 (stability) information are required. The report must cover all the NHP related activities, equipment and buildings at the site. The NSF audit is valid for a period of three years from the date of the audit.
  • US FDA Establishment Inspection Report (FDA EIR): Note that if the inspection was conducted according to the FDA GMP standards for dietary supplements, it does not include equivalent requirements related to testing as indicated in Part 3 of the Regulations. Therefore, along with the inspection report, the 483 form and associated corrective actions, section 44 (finished product testing) and 52 (stability) information are required. The report must cover all the NHP related activities, equipment and buildings at the site. The FDA audit is valid for a period of three years from the date of the audit.

Missed renewal or cancelled site licence

If the applicant previously conducted activities under a Site Licence that expired, was refused or cancelled by the NNHPD, then a SNC form is required in place of a QAR form, even though the application is considered new.

Previous Issuance Letter Observations

Review past issuance letters for observations made by NNHPD at the conclusion of previous application reviews. You will be required to provide evidence that all observations have been corrected with your Renewal or Amendment documents, accordingly.

Foreign site(s)

This is the building (or buildings) where licensable activities, manufacturing, packaging, labelling are performed outside of Canada. This section is mandatory for completion solely if the Licence Type was selected as "foreign site Reference Number" or if a Canadian site was selected as being an importer of NHPs.

For Importers

Only include foreign sites implicated in the application, meaning for:

  • New SL applications: Include information for all foreign Sites that are proposed to conduct licensable activities following the emission of the site licence.
  • SL Renewals: All foreign sites authorized to conduct activities on the previous site licence that are to be renewed. Should sites need to be removed from the site licence at renewal, do not list them as foreign sites under this application and they will be removed following the review of the renewal.
  • SL Amendments: Include foreign sites proposed to be amended to the site licence. Unless the amendment concerns a foreign site already included under the SL, adding already licenced sites is not necessary for amendment applications as the link between the site licence holder and the amendment to their site licence is already made Applicant or Licensee page.

For FSRN Applicants

  • New FSRN application: Include all information for the site involved in licensable activities. Note that only 1 site can be included per FSRN. Should an applicant wish to obtain a FSRN for more then 1 of their sites, multiple FSRN applications should be provided.
  • FSRN modification: Include site(s) to be updated or modified.
  • FSRN GMP Evidence Update: Include site(s) to undergo a GMP Evidence Update.

Company Name

This is a free form text field. Enter the full name of the building conducting licensable activities with natural health products. Do not abbreviate company name.

Address

Provide the full address of the building identified in the building name field. Do not enter a P.O. Box or mailing address, enter the address of the building where activities are conducted. If a suite/unit number is used, provide the suite/unit number in addition to the street and street number, the city/town, the province and the postal code.

Postal/ZIP codes must be displayed in the appropriate format (X#X #X#, X#X#X#, or #####, where X represents a letter and # a number).

Dwelling house

Indicate if the proposed site is a place of residence.

Quality Assurance Person for this Site

The individual who is responsible for assuring the quality of the NHP before it is made available for sale. This person should be qualified by education, training and/or experience relating to the specific activity (i.e. manufacturing, packaging, labelling and/importing).

Phone and fax numbers must be entered in the appropriate format (regional code (###)-###-####, for Canada and United States, where # represents a number).

Email addresses must be entered in the appropriate format (X#@X#.XXX, where X represents a letter and # a number. X# represents a combination of letters and numbers of varying length)"

Changes to this site

This section is used to describe changes to a site during an amendment application. Select only those that apply. This section opens for completion solely if "Amendment" or "Notification" was selected as the Application Type.

  • Name/Address: Select if the building entered in this section has gone through a name change or changed addresses. Select this option only for changes to a site already on the company's site licence or FSRN.
  • QAP Information: Select if the QAP information for the building entered in this section has changed.
  • Activities: Select if the approved activities for the building entered in this section are to be changed. Select this option only for changes to a site's activities already on the company's site licence or FSRN.

Storage/Warehouse only

Indicate if the building will be used for warehousing/storage only, in which case indication of additional activities will not be necessary for this site. Storage and warehousing refer to a site, also called a warehouse, whose main purpose is to hold natural health products.

Activity Types

The available activity types are as follows:

  • Manufacturing: Refers to a person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of the patient, compounds a natural health product for the purpose of sale to that patient.
  • Packaging: Refers to a person who puts a finished natural health product in its immediate container. Not to be confused with secondary packaging, defined as placing an NHP in its immediate package/container into a secondary package/container, which under the Natural Health Products Regulations, is considered labelling of NHPs. A site conducting solely secondary packaging should select solely "Labeller" as activity type.
  • Labelling: Refers to a person who affixes the inner or outer label of the natural health product. A label is defined as including any legend, word or mark attached to, included in, belonging to or accompanying any Natural health product. Note that secondary packaging, defined as placing an NHP in its immediate package/container into a secondary package/container, is considered labelling of NHPs under the Natural Health Products Regulations. A site conducting solely secondary packaging should select solely "Labeller" as activity type.

Categories of products

The available categories of products are as follows:

  • Non-sterile: Refers to a natural health product, a substance set out in Schedule 1 of the Natural Health Products Regulations or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, that is not defined as sterile or homeopathic product.
  • Sterile: Refers to products manufactured, packaged, labelled or imported in a dosage form that is free from viable microorganisms. Should sterile activities be selected, sufficient GMP evidence to demonstrate compliance with sections 59 and 60 of the Natural Health Products Regulations must be provided, along with the required acceptable GMP evidence for this site.
  • Homeopathic: Refers to medicines that are manufactured from or contain as medicinal ingredients only those substances or sources referenced in The Homeopathic Pharmacopoeia of the United States (HPUS), the Homöopathische Arzneibuch (HAB), the Pharmacopée Française (PhF) or the European Pharmacopoeia, as amended from time to time, and that are prepared in accordance with these pharmacopoeias. Should homeopathic activities be selected, a SQAR must be provided in addition to a QAR as this form covers all the additional GMP requirements for homeopathic medicines as outlined in Appendix 1 of the GMP guidance document.

Note: if this is a FSRN GMP Evidence Update, only activities authorized in the most recent issuance of the FSRN will be renewed. Changes to activities should be done by submitting a site licence amendment.

GMP Evidence for foreign sites

The acceptable GMP evidence to provide for this site is dependent on the Application Type selected in the previous section of the form, therefore some types of evidence listed below may not be shown as an option. Select the GMP evidence to be provided for this site:

  • Quality Assurance Report: The QAR form is a report prepared by the quality assurance person responsible for the site, who has the training, experience and technical knowledge relating to the activities conducted and the requirements of Part 3, GMP, of the Regulations. This report is based on the assessment against the GMP requirements set out in the GMP guidance document. The QAR is considered to be an attestation by the applicant that the site meets all the requirements of Part 3, GMP, of the Regulations. A QAR is valid for a period of one year from the date of completion by the quality assurance person. Only acceptable as evidence for new applicants that never held a licence previously, or if adding a new site to an existing site licence.
  • Supplementary Quality Assurance Report : Manufacturers of NHPs used in homeopathy must complete and submit this form in addition to the standard QAR. This form covers all the additional GMP requirements for homeopathic medicines as outlined in Appendix 1 of the GMP guidance document. The SQAR is valid for a period of one year from the date of completion by the quality assurance person. Only acceptable as evidence for new sites that will conduct activities with homeopathic products.
  • Summary of Net Changes: A report prepared by the quality assurance person responsible for the site, who has the training, experience and technical knowledge relating to the activities conducted and the requirements of Part 3, GMP, of the Regulations. This report allows the applicant to identify changes to the site which have occurred since the QAR was provided. The SNC is considered to be an attestation by the applicant that the site meets all the requirements of Part 3, GMP, of the Regulations. Samples of specific completed records from within the last 12 months are required along with the SNC form. Though the NNHPD may request additional records based on the totality of information provided and the assessment conducted, one sample record is required for each section per site. If there have been changes to the building(s), practice(s) and procedure(s), you are also required to complete and submit the relevant section(s) of the QAR form or provide another form of acceptable GMP evidence to support the change(s). The SNC is valid 1 year from date of completion.
  • Drug Establishment Licence: DEL holders may submit a copy of their current DEL demonstrating compliance with the requirements of part C, divisions 2 to 4 of the FDR. The DEL lists all buildings where activities are authorized for drug products under the FDR. By submitting a DEL, the site licence applicant is attesting to following the same standards for NHPs as for drugs. The DEL holders must submit alternate evidence of GMP compliance for those additional NHP related activities and building addresses that were not inspected and are not listed. The evidence remains valid for a period of three years from the date of inspection.
  • GMP Certificate from a Qualified Authority: A qualified authority is an authority member from a country where Health Canada has a MRA regarding GMP for drug products, or an authority member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) regarding GMP for drug/human medicinal products. A list of PIC/S members can be found on the PIC/S website and a list of MRA authorities can be found on the Health Canada website. The certificate must cover all the NHP related activities, equipment and buildings at the site and must be provided in one of Canada’s official languages. A certificate from a qualified authority is valid for a period of three years from the date of the inspection.
  • NSF Standard 173 section 8 Certificate: NSF International Standard 173, Section 8 for Dietary Supplements Certificate has been found to partially cover the requirements of Part 3, GMP, of the Regulations and may be submitted in support of a site licence application along with additional supporting information. Specifically, this standard does not include equivalent requirements related to testing as indicated in Part 3 of the Regulations. Therefore, along with the inspection report and corrective actions, section 44 (finished product testing) and 52 (stability) information are required. The report must cover all the NHP related activities, equipment and buildings at the site. The NSF audit is valid for a period of three years from the date of the audit.
  • UL Report: UL Report has been found to partially cover the requirements of Part 3, GMP, of the Regulations and may be submitted in support of a site licence application along with additional supporting information. Specifically, this standard does not include equivalent requirements related to testing as indicated in Part 3 of the Regulations. Therefore, along with this evidence type, section 44 (finished product testing) and 52 (stability) information are required. The report must cover all the NHP related activities, equipment and buildings at the site. The NSF audit is valid for a period of three years from the date of the audit.
  • US FDA Establishment Inspection Report (FDA EIR): Note that if the inspection was conducted according to the FDA GMP standards for dietary supplements, it does not include equivalent requirements related to testing as indicated in Part 3 of the Regulations. Therefore, along with the inspection report and corrective actions, section 44 (finished product testing) and 52 (stability) information are required. The report must cover all the NHP related activities, equipment and buildings at the site. The FDA audit is valid for a period of three years from the date of the audit.

Note: The validity period of a FSRN depends on the type of GMP evidence provide for the site and its validity period as described above. The FSRN could have a validity period of up to three years.

Missed renewal or cancelled site licence

If the applicant previously conducted activities under a site licence that expired, was refused or cancelled by the NNHPD, then a SNC form is required in place of a QAR form, even though the application is considered new.

Previous Issuance Letter Observations

Review past issuance letters for observations made by NNHPD. You will be required to provide evidence that all observations have been corrected with your Renewal or Amendment documents, accordingly.

Product Information

List all Natural Health Products that have been handled in the last 12 months at the sites included in this application and/or the NHPs planned to be handled in the next 12 months following the issuance of a new or amended site licence. Do not include product information for sites not implicated in the application. This sub-section is mandatory for amendment and renewal applications as it is expected the site licence holder keeps records of the products manufactured, packaged, labelled and/or imported by their company and all foreign under their SL. This sub-section is optional for new SL applications, notifications of change and all FSRN application types. However, should this information be known, we ask this sub-section is filled by the applicant.

For each product, the applicant is to include the NPN and Brand Name of the product as well as its manufacturer, packager and labeler.

To input product information, select the "Add a product" button. In the "Product information table" select "Modify" next to the corresponding product. On the "Product page", input all required information and select the "Continue" button to save the information and return to the site information table. To add a new product, select the "Add product" button. To remove a product, select the "Remove" button in the corresponding row.

Natural product Number or Homeopathic Medicine Number

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 NPN or DIN-HM, which must appear on the label. This number lets you know that the product has been reviewed and approved by Health Canada.

The NPN included will be verified against the Licenced Natural Health Product Database(LNHPD). The brand name associated to a NPN will be automatically pulled from the LNHPD. Should you find a discrepancy between the NPN and associated brand name as a result of a recent change, contact nnhpd-dpsnso@hc-sc.gc.ca for help in resolving the issue.

Supply Chain

Choose, from the list of companies included as Canadian and foreign sites in previous sections, the manufacturer, packager or labeller of the product. Should the site conducting the relevant activities not be available in the selection list, select "Other" and write the company name. Please note this site should hold their own site licence for the performed activity or already be listed on your licence.

Date modified: