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Drugs and Health Products

Site Licensing Guidance Document

Natural and Non-prescription Health Products Directorate
December 1, 2015 - Version 3.0

Table of Contents

 

1.0 General overview

1.1 Purpose of the Site Licence Regulatory Requirements

Part 2 (sections 26 to 42) of the Next link will take you to another Web site Natural Health Products Regulations (the Regulations) sets out the requirements, rights, and responsibilities of the licensee and the Natural and Non-prescription Health Products Directorate (NNHPD) in regards to site licensing. The purpose is:

  • To ensure that the NNHPD is aware of all the sites at which businesses are manufacturing, packaging, labelling, importing, and/or storing Natural Health Products (NHPs) in Canada.
  • To require persons to meet the regulatory requirements related to manufacturing, packaging, labelling, and/or importing NHPs for sale; and
  • To require site licence holders to demonstrate that they comply with the Good Manufacturing Practices (GMP) outlined in Part 3 of the Regulations.

1.2 Purpose of this guidance document

The purpose of the Site Licensing guidance document is to outline the way that the NNHPD manages site licence applications (SLAs) submitted in accordance with the Regulations. This guidance also outlines the responsibilities and expectations for NHP site licence applicants before and throughout the application review process and for site licence holders following the issuance of a site licence.

The Site Licensing guidance document is also intended to assist site licence applicants in interpreting Part 2, (Site Licences), of the Regulations with respect to the application requirements. Included in this guidance document is a description of the different application types and their specific requirements.

1.3 What is a site licence?

Section 27 of the Regulations requires a manufacturer, packager, labeller, and/or importer of NHPs for sale to hold a valid site licence. A site licence issued by the NNHPD gives the licensee authorization to conduct the activities listed on the licence.

These activities must be carried out according to the GMP outlined under Part 3 of the Regulations. For more information on GMP see the Good Manufacturing Practices guidance document.

Part 2: Site Licences
Prohibition
Section 27

  1. Subject to subsection (2), no person shall manufacture, package, label or import a natural health product for sale unless
    1. the person holds a site licence issued in respect of the activity; and
    2. the person conducts the activity in accordance with the requirements set out in Part 3.

  2. No person who holds a site licence shall manufacture, package, label or import a natural health product for sale
    1. during the period of any suspension of the licence under section 39 or 40; or
    2. after cancellation of the licence under paragraph 41(b).

In order to maintain the validity of the site licence, a licensee must renew and amend (if applicable) his/her site licence, and notify the NNHPD of changes to the information submitted in their site licence application, as required by the Regulations. A licensee must stop performing all previously authorized activities during a period of any suspension or cancellation of the site licence. Licensee obligations are further described in Chapter 4.

1.4 Who requires a site licence?

Section 27 of the Regulations states the activities for which a site licence is required and the activities that are covered by the 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.

Notes on importing NHPs:

  • Any person (business or individual) that brings into Canada a finished NHP for the purpose of sale is considered to be an importer under Part 2 of the Regulations.
  • Importers that ship a product directly to the retailer without first storing the product require a site licence and, must be compliant with all the GMP requirements relating to the site licence.

Retailers selling products that they themselves have imported are considered the importer and, therefore, require a site licence and, must be compliant with all the GMP requirements relating to the site licence.

Products manufactured, packaged and labelled at foreign sites

Canadian importers are required to be licensed and the onus is on them to provide evidence that products coming from foreign sites meet Canadian GMP under Part 3 of the Regulations or their equivalent. Information related to approved foreign sites is listed on the importer's site licence. It is the importer's responsibility to ensure that the reports submitted to the NNHPD are complete and that all requirements of Part 3, GMP, of the Regulations are met for all foreign sites.

A site licence is not required by:

  • 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.
 

2.0 Applying for a site licence

Section 28 of the Regulations outlines the basic requirements for a complete site licence application.

Part 2: Site Licences
Licence Application
Section 28

An application for a site licence shall be submitted to the Minister and shall contain the following information and documents:

  1. the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of the applicant;
  2. a statement specifying which one or more of the activities of manufacturing, packaging, labelling or importing the applicant is proposing to conduct;
  3. if the applicant is proposing to manufacture, package or label a natural health product, the address of each building in which each activity is proposed to be conducted;
  4. if the applicant is proposing to import a natural health product, the address of each building in which that natural health product is proposed to be stored;
  5. for each activity specified under paragraph (b), a statement indicating whether or not the applicant is proposing to conduct the activity in respect of a natural health product in sterile dosage form; and
  6. in respect of the buildings, equipment, practices and procedures used to conduct each activity specified under paragraph (b), a report from a quality assurance person demonstrating that they comply with the requirements set out in Part 3.

To apply for a site licence, applicants must provide to the NNHPD, a site licence application which includes the following forms and documents:

  1. Site Licence Application (SLA) Form: The Site Licence Application Form captures all of the information outlined in section 28 (a) to (e) of the Regulations, as stated above.
  2. Designated Party Authorization (DPA) Form (when applicable): Applicants/licensees who have designated a third party person to file a submission with the NNHPD on their behalf must submit a Designated Party Authorization Form. This form must be resubmitted with each application and/or when the designated party changes.
  3. Evidence of GMP compliance, as per Part 3 of the Regulations, for each site.

    This may be demonstrated by providing a certificate from a qualified authority or a complete Quality Assurance Report (QAR) form as described below.

    Reminder: Importers must also submit evidence of GMP compliance for each foreign site with their site licence application, as described below.

2.1 Evidence of GMP compliance

2.1.1 Pre-Cleared Evidence

Pre-cleared evidence includes certificates from qualified authorities (including Health Canada) as described below. The following certificates have been assessed by the NNHPD and are considered to adequately demonstrate compliance with Part 3, GMP, of the Regulations in full or in part:

  1. Drug Establishment Licence (DEL). Drug establishment licence 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 evidence remains valid for a period of three years from the date of inspection.

    *Valid foreign sites listed in the foreign site annex of a DEL held by the importer do not require further evidence of GMP compliance. However, the activities and building addresses for the foreign site(s) listed in the annex must match up exactly with those indicated in the site licence application.
  2. Foreign Site Reference Number (FSRN) Authorization. The NNHPD may issue a FSRN to a foreign site that has demonstrated compliance to Part 3, GMP, of the Regulations via a separate FSRN application process. Once issued a FSRN, foreign site owners may authorize Canadian importers to reference their FSRN as an alternative to providing GMP evidence for their site. This process protects confidential manufacturing information and helps to expedite the review process. The FSRN is valid for a period of one or three years from the date of issuance, depending on the type of supporting GMP evidence provided in support of the foreign site. For more information on how to apply for a FSRN, see Appendix A: Obtaining a Foreign Site Reference Number
  3. Good Manufacturing Practices (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). A list of PIC/S members can be found on the Next link will take you to another Web site 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. A certificate from a qualified authority is valid for a period of three years from the date of the inspection
  4. Based on the volume of applications assessed over time, 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 the following additional supporting information:
    • 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.

Note, additional information on evidence validity and your obligation to renew a site licence is described in 2.1.4.

2.1.2 Quality Assurance Report (QAR)

  • The Quality Assurance Report (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 Good Manufacturing Practices 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.
  • Supplementary Quality Assurance Report (SQAR) form (when applicable). 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 Good Manufacturing Practices guidance document. The SQAR is valid for a period of one year from the date of completion by the quality assurance person.
  • It is to be noted that elements of the QAR can only be completed following an on-site verification by the quality assurance person.

2.1.3 Use of alternate GMP standards and/or accreditation bodies

The NNHPD recognizes there are other accreditation bodies that maybe capable of conducting high quality audits/inspections to various international GMP standards. The NNHPD promotes independent on-site verification of compliance as it may provide a greater level of assurance that products sold in Canada meet appropriate standard of quality.

With the implementation of service standards for site licensing and the nature of a paper-based review process, the NNHPD must ensure a degree of predictability in the review process. This precludes the NNHPD from being able to assess different standards and/or accreditations, without the use of the QAR, during the review of an application given the varying amount of effort required.

Applicants may submit other audits or inspection reports (with corrective actions) along with their QAR to assist in demonstrating compliance with Part 3, GMP, of the Regulations. This will allow the applicant to use the report and assist the NNHPD by facilitating the review given each report may be laid out differently and/or to standards not assessed by the NNHPD for equivalency to Part 3, GMP, of the Regulations. In this case, each section of the QAR must be completed and reference the appropriate section and page(s) of the report as supporting information if it was verified during the audit or inspection. Records/ standard operating procedures and/or other supporting information are required in the cases where the requirements were not verified as per the QAR. Records relating to finished product testing, product release and stability will be required in all cases as per the QAR. An audit or inspection report (other than those referenced in Chapter 2.1.1) will not be accepted as a standalone document. A QAR, along with a supporting audit or inspection report are valid for a period of one year from the date of completion of the QAR and/or the audit or inspection report (whichever is less).

For example, a corporate audit or third party audit report may be submitted along with the QAR. Appropriate sections of the audit report should be referenced in the QAR. Further, qualifications of the auditor or the person responsible of the inspection, standard used for the audit, and corrective actions (if applicable) are also required.

Required site licensing forms related to the application process can be found on the NNHPD website.

2.1.4 Period of Validity

Evidence must be valid at the time of submission as per the validity periods outlined above for each evidence type. This means that domestic and foreign sites may rely on the same certificate or report for future renewal applications provided the certificate or audit report remains valid as per the period mentioned above.  However, an application for renewal remains a requirement as per the renewal cycles described in section 36 of the Regulation and further described in section 4.1 of this guide.

2.2 Filing a site licence application

2.2.1 Filing of a site licence application by secure email

The NNHPD strongly encourages applicants to file SLAs, Post-licensing Changes, and Information Request Notice (IRN) responses electronically via the NNHPD's secure email service: epost Connect™. In order to use epost Connect™, applicants must be enrolled as a Trading Partner. Guidance on the use of epost connect can be found in the guidance document, How to Interact with the Natural and Non-prescription Health Products Directorate Electronically.

2.2.2 Filing of a site licence application on CD or DVD

Although applicants are strongly encouraged to enroll as Trading Partners and submit applications via epost Connect™, as mentioned above, it is also possible to submit the SLA form and supporting documents by mail or courier. In this scenario, applicants are encouraged to submit a CD or DVD containing the SLA form and all supporting documents.

Applications submitted by mail or courier may be sent to:

Health Canada
Health Products and Food Branch
Natural and Non-prescription Health Products Directorate
Bureau of Licensing and Services Systems
Submission Management Division
2nd floor, Qualicum, Tower A
2936 Baseline Rd, AL 3302B
Ottawa, Ontario  K1A 0K9
(Couriers: K2H 1B3)

2.2.3 Filing of a site licence application in paper format

If applicants cannot submit applications and supporting documents through epost Connect™, nor on CD or DVD, the SLA form and supporting documents can be printed and submitted by mail or courier. Please note that it is the intent of the NNHPD to only accept applications submitted electronically in the future.

 

3.0 Submission management

The purpose of this chapter is to outline the way the NNHPD will manage applications for a new site licence, renewal of a site licence, and notification or amendments to a site licence submitted in accordance with the Regulations. It also outlines the responsibilities and expectations for applicants before and throughout the application review process.

3.1 Processing and assessment of the application

For site licence applications, a covering letter should be included and indicates whether the supporting evidence of GMP compliance provided for each site is Pre-cleared evidence or a quality assurance report (QAR) based on the definitions below. This will ensure the application is reviewed according to its designated service standard. In the case of an amendment application, the cover letter should also outline the applicable changes to be assessed.

All applications will be examined for administrative completeness. Applications meeting administrative requirements will be sent an Application Acknowledgement Letter within 5 business days. Applications that are deficient with respect to administrative content will result in the issuance of a Rejection Notice - Administrative Deficiency. Administrative deficiencies are described in Chapter 3.1.3.

3.1.1 Application completion timelines

Timelines are indicated in business days (calendar days minus weekends and statutory holidays). A summary of service standards for the management of site applications can be found in table 1 below.

Pre-cleared evidence (as indicated in Chapter 2.1.1)

Complete applications which include only valid certificates from a qualified authority as evidence of GMP compliance for every site, as described in Chapter 2.1.1. will receive a decision regarding their site licence application within thirty (30) business days from the date of acknowledgement.

Quality Assurance Report (QAR)

Complete applications which include a QAR as evidence of GMP compliance for one or more sites as described in Chapter 2.1.2 will receive a decision regarding their site licence application within sixty (60) business days from the date of acknowledgement. These applications will be accepted into the assessment queue and reviewed for GMP compliance as outlined in Part 3 of the Regulations and in the Good Manufacturing Practices guidance document. Of note, for such applications including 10 or more sites, up to an additional thirty (30) business days may be required for assessment, depending on the complexity and type of supporting information provided for each site.

Significant deficiencies or information omissions that preclude the ongoing review may be transmitted to the applicant in a notice of refusal; however, in most instances, the NNHPD will provide the opportunity for the applicant to address deficiencies or information omissions through an Information Request Notice (IRN). For the purpose of maintaining an efficient assessment process, the NNHPD will aim to issue one comprehensive IRN. In certain situations, a second IRN may be issued but this should not be recognized as standard practice. Once a response is deemed complete, the review process will resume. The NNHPD reserves the right to request clarification on the information submitted.

If the IRN response is deemed deficient or if the applicant does not satisfy all requirements, a notice of refusal may be issued. If the applicant wishes to re-submit the application at a future time, it will be processed as a new application.

Table 1: Summary of Service Standards for the Management of Site Applications
Application Type Administrative Processing for Application Completeness GMP Assessment and Decision Issuance
Applications which include Pre-cleared GMP evidence for every site (no limit on # of sites) Applications which include 1-9 sites and include a QAR as GMP evidence for one or more sites Applications which include 10 or more sites and include a QAR as GMP evidence for one or more sites
Site Licence (SL):
  • New Application
  • Renewal
  • Amendment
5 days 30 days 60 days Up to 90 days
Foreign Site Reference Number (FSRN):
  • New Application
  • FS Renewal
  • FS Amendment
5 days 30 days 60 days n/a
Notification (SL and FSRN) 15 days

* All timelines are in business days

3.1.2 Requests for information

The NNHPD may communicate with applicants by telephone, email (including epost Connect™) or fax at any point upon application receipt. The NNHPD will issue requests for information in the form of an IRN with a specified response time indicated in the notice, in most cases 15 business days. The NNHPD reserves the right to request clarification of the information submitted and/or issue a refusal notice if the applicant does not provide a complete response in the allocated timeframe.  The NNHPD will consider requests for extensions on a case by case basis.  It should be noted that the NNHPD will strive to meet service standards for all applications, however, applicant initiated extension requests may prevent the NNHPD from being able to meet its target service standards.  Thus, extensions (if granted) may result in applications being excluded from NNHPD's service standard outlined in this document.

3.1.3 Deficiencies in the application

Deficiencies in the application can range from minor and easily correctable, to major or critical, which may indicate that the applicant did not demonstrate GMP compliance and thus prevent the applicant from meeting the requirements outlined in the Regulations. Deficiencies may prevent further assessment of the application without the provision of additional information from the applicant. Should the information be deemed inadequate by the NNHPD, deficiencies may ultimately result in the refusal of the site licence application.

Part 2: Site Licences
Additional Information
Section 37

If the information and documents submitted in respect of an application under section 28, an application for amendment under subsection 32(2) or a request for renewal under section 36 are insufficient to enable the Minister to determine whether the licence should be issued, amended or renewed, as the case may be, the Minister may request that the applicant provide the Minister with such additional information as is necessary to make the determination.

Appendix 5 of the Good Manufacturing Practices Guidance Document outlines the risk classification for natural health products' GMP observations. This is a useful tool intended to describe such observations noted during a natural health product site licence assessment (new application, amendment or renewal), inspection or audit. This information can also be used by a company's quality assurance person when conducting a GMP self-inspection.

The NNHPD assessment officers will use this document to assign a level of risk to noted GMP deviations in the evidence provided in order to assess GMP compliance. The assessment officer may address these observations by communicating them as deficiencies and requesting additional information according to section 37 of the Regulations through an Information Request Notice (IRN). Deficiencies are classified into 4 categories based on the risk classification of the observation as described in Appendix 5 of the Good Manufacturing Practices Guidance Document. The applicant is required to respond to an IRN within the timeline specified. Note that only a single consolidated response to all the deficiencies noted in the IRN should be provided. There are four types of deficiencies:

  • Administrative deficiencies are those that are not related to observations in the evidence of GMP compliance provided. These include missing forms (such as DPA form), documents (failure to provide any evidence of GMP compliance), signatures (on the SLA and evidence of GMP compliance), contact information (in the SLA form) etc.
  • Minor deficiencies (risk type 3 observations) may not require immediate correction; however, they may still indicate a deviation from GMP. Depending on the nature of the deficiency, NNHPD may request additional information prior to proceeding with the assessment or may request corrective action from the company, which will then be verified at renewal. Numerous minor deficiencies may accumulate to a major deficiency, at which time additional information would be required in order to proceed with the assessment.
  • Major deficiencies (risk type 2 observations) are those which could result in an NHP that does not meet terms of market authorization and/or results in a failure to follow GMP as per Part 3 of the Regulations, including failure of the quality assurance person to fulfill his/her responsibilities. If major deficiencies are identified, additional information will be required. Numerous major deficiencies may be considered a GMP deficiency trend, and thus be considered a critical deficiency.
  • Critical deficiencies (risk type 1 observations) are GMP deviations that can result in or are likely to result in a non-compliant product or an immediate or latent health risk. These include, but are not limited to, observations of fraud, product adulteration, misrepresentation and/or falsification of data, widespread cross-contamination, infestation, or unsanitary conditions. Failure to provide the critical information within the allocated timeframe will result in the refusal or withdrawal of the submission. In this case, the applicant will be encouraged to re-submit a new application once they have resolved the deficiencies. Evidence or statements that are identified to be false or misleading will be considered a critical deficiency and will result in the refusal of the submission.

In general, as a result of a risk 1 observation, the NNHPD may suspend, cancel, or refuse to issue, amend or renew the site licence. Upon discovery of a risk 1 observation, Health Canada may provide the company with the opportunity to take immediate corrective actions.

Any person who conducts an activity or sells an NHP in contravention of the Food and Drugs Act and/or Natural Health Products Regulations may be subjected to compliance and enforcement actions.  Refer to the Health Products and Food Branch Inspectorate - Natural Health Products Compliance and Enforcement Policy (POL-0044) for more information on the approach to non-compliance and associated risk mitigation activities for NHP manufacturers, packagers, labellers and importers.

Note: For a site licence renewal with the activity of importation, a critical deficiency for one or more of the approved foreign sites will result in the removal of the foreign site(s) from the site licence but not the refusal of the submission, unless no active foreign sites remain valid for the site licence. An importer may not hold a valid site licence without a foreign manufacturer, packager, or labeller annexed.

For additional information regarding GMP, please see the Good Manufacturing Practices guidance document on the Health Canada website.

3.1.4 Withdrawing an application

If, at any point during the application process, the applicant wishes to retract a submission, they may notify the NNHPD in writing of their wish to withdraw their submission in part or in full.

3.2 Decision

Sections 29 to 31 of the Regulations outline the reasons and procedures for the issuance or refusal to issue a site licence.

Part 2: Site Licences
Issuance and Amendment
Section 29

  1. The Minister shall issue or amend a site licence if
    1. the applicant submits an application to the Minister that is in accordance with section 28 or subsection 32(2), as the case may be;
    2. the applicant provides the Minister with all additional information requested under section 37; and
    3. the applicant does not make a false or misleading statement in the application.

  2. If the Minister issues a site licence, the Minister shall assign that licence a site licence number.
 

Part 2: Site Licences
Refusal to Issue or Amend
Section 30

  1. If the Minister refuses to issue or amend a site licence, the Minister shall send the applicant a notice that sets out the reason for the refusal.

  2. Within 30 days after the day on which the notice is sent, the applicant may make a request that the Minister reconsider the application.

  3. If the applicant makes a request in accordance with subsection (2), the Minister shall
    1. give the applicant an opportunity to be heard in respect of the application; and
    2. reconsider the application after giving the applicant that opportunity.
 

Part 2: Site Licences
Refusal to Issue or Amend
Section 31

  1. After reconsidering the application, the Minister shall issue or amend the site licence if the requirements of subsection 29(1) are met.
  2. If the Minister again refuses to issue or amend the site licence, the Minister shall send the applicant a final notice that sets out the reason for the refusal.

3.2.1 Site licence issuance

The NNHPD will only issue or amend a site licence when the applicant has submitted a complete submission with all the required supporting information that demonstrates that the site is compliant with the Regulations.

Part 2: Site Licences
Licence Contents
Section 34

A site licence shall set out the following information:

  1. the name and address of the licensee;
  2. the site licence number;
  3. each activity that the licensee is authorized to conduct and a statement indicating whether the activity is authorized to be conducted in respect of a natural health product in sterile dosage form;
  4. if the licensee is authorized to manufacture, package or label a natural health product, the address of each building in which the licensee is authorized to conduct that activity; and
  5. if the licensee is authorized to import a natural health product, the address of each building in which the licensee is authorized to store that natural health product.

The site licence contains the assigned site licence number, the name and address of the licensee, applicable activities, issuance and expiry dates, and the address of each building in which the licensee is authorized to conduct that activity. For importers, the licence will also include the name(s), address(es), and activities of the foreign site(s) from which the importer is authorized to import NHPs for sale. Domestic and foreign warehouses are also listed. A copy of the site licence will be sent to the licensee. Site licence holder information, with the exception of foreign site relationships, is also posted publicly on the Health Canada website.

3.2.2 Refusal to issue a site licence

The NNHPD may refuse to issue or amend a site licence when the site is deemed not compliant with the GMP requirements set out in Part 3 of the Regulations, when there is insufficient information to ascertain compliance, when the applicant does not provide additional information on request within the timeline specified, or when the information submitted is deficient, false or misleading. When a site licence application is refused, the NNHPD sends the applicant a notice of refusal stating the reasons for refusal.

If an applicant wishes to resubmit an application at a future time, it will be processed as a new application. Information and data submitted to support the original application will not be returned to the applicant and will be maintained by the NNHPD per the required retention schedule and procedures.

3.2.3 Request to reconsider

If the applicant would like the NNHPD to reconsider a refusal as per section 30 of the Regulations, he or she may make such a request by submitting a letter to the attention of Manager, Submission Management Division, within thirty (30) calendar days after the day on which the notice of refusal is sent. If such is the case, the NNHPD will give the applicant an opportunity to be heard regarding the refusal, after which the NNHPD will reconsider the initial refusal and decide whether to refuse, issue, or amend the site licence. If the decision is made to uphold the refusal, to issue, amend, or renew a site licence, the NNHPD sends the applicant a final notice stating the reason(s) for upholding the refusal. If the NNHPD's decision is overturned, a licence will be issued, amended, or renewed, or the assessment of the application will continue. For detailed information on the reconsideration process and requirements, refer to the NNHPD Reconsideration Process guidance document on the Health Canada website.

 

4.0 Obligations of licensees

This chapter explains the obligations licensees must meet to maintain their site licence. In particular, it explains when the licence expires, and how it can be renewed before it expires (Chapter 4.1), when it requires amendment (Chapter 4.2) or notification (Chapter 4.3), the different situations that will lead to a suspension or cancellation of a licence, and the requirements to stop performing all previously authorized activities during a period of any suspension or cancellation (Chapter 4.4).

Prior to commencing the sale of a NHP in Canada, the product licence holder shall provide the NNHPD with information, as defined in section 22 of the Regulations, concerning the relevant names, addresses and contact details of each manufacturer, packager, labeller, importer and distributor with their corresponding site licence numbers if activities are conducted in Canada. In the future, the NNHPD will require Site Licence holder to provide a list and/or information on NHPs manufactured, packaged, labelled, imported or distributed at their site, which are intended for sale in Canada at the time of application, renewal and amendment (if applicable).

4.1 Site licence expiry and renewal

A site licence will expire on the first anniversary of the day of issuance unless renewed as per section 36 of the Regulations. It is the site licence holder's responsibility to submit a complete renewal application in sufficient time to the NNHPD based on the summary of service standards for the management of site applications outlined in Table 1. For example, the renewal of a site licence with only pre-cleared evidence should be submitted at least 35 days before it is set to expire. Failure to do so may result in the inability to renew a licence before it expires. Manufacturers, packagers, labellers and importers cannot conduct activities without a valid site licence. Note, all applicants must submit their application a minimum of thirty (30) days prior to the expiry date of the site licence as per the requirements set out in section 36(1)(a) of the Regulations. The NNHPD will not remind applicants of their expiry dates.

Part 2: Site Licences
Expiry
Section 35

  1. A site licence expires on the first anniversary of the day on which it was issued unless it is renewed in accordance with section 36.
  2. A site licence that is renewed in accordance with section 36 expires on the day on which the renewal period ends unless the licence is further renewed in accordance with section 36.

 

Part 2: Site Licences
Renewal
Section 36

  1. The Minister shall renew a site licence if
    1. the licensee submits a request to renew the licence to the Minister no later than 30 days before the day on which the licence expires;
    2. the licensee provides the Minister with all additional information requested under section 37; and
    3. the renewal of the licence is not likely to result in injury to the health of a purchaser or consumer.

  2. If the Minister renews a site licence, the Minister shall renew it for a period of
    1. one year, if on the next anniversary of the day on which the licence was issued, the licensee will have held the licence for a period of less than three years;
    2. two years, if on the next anniversary of the day on which the licence was issued, the licensee will have held the licence for a period of at least three years but less than nine years; or
    3. three years, if on the next anniversary of the day on which the licence was issued, the licensee will have held the licence for a period of nine years or more.

  3. A site licence renewal becomes effective on the day after the anniversary of the day on which the licence was issued.

Section 36 of the Regulations defines the site licence expiry and renewal periods. 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.
Table 2: Site licence renewal cycle
  Site Licence issued by the NNHPD (Date of Issuance) 1st Date of Renewal 2nd Date of Renewal 3rd Date of Renewal 4th Date of Renewal 5th Date of Renewal 6th Date of Renewal** 7th Date of Renewal 8th Date of Renewal
Renewal Cycle Jan 1, 2014 Jan 1, 2015 Jan 1, 2016 Jan 1, 2017 Jan 1, 2019 Jan 1, 2021 Jan 1, 2023 Jan 1, 2026 Jan 1, 2029
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.
GMP Evidence Required Pre-cleared evidence or QAR for each site Pre-cleared evidence or SNC and records for each site

The site licence holder will submit a request to the NNHPD to renew his/her licence by submitting an application and acceptable evidence of GMP compliance as outlined below.

Each site listed on the site licence and originally authorized based on pre-cleared evidence is required to submit one of the following:

  • If the certificate provided previously remains valid at the time of renewal, no additional information is required. In this case, the applicant must indicate as such in their site licence application cover letter.
  • If the certificate is expired at the time of renewal and a new one is not obtained a Summary of Net Changes (SNC) form will be required as described below.

Each site listed on the licence and originally authorized based on QAR information are required to submit the following:

  • A Summary of Net Changes Form (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. 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.

Alternatively, applicants may opt to provide pre-cleared evidence in lieu of a SNC if a certificate was obtained since the submission of a QAR.

Under the Natural Health Products Regulations a company is not permitted to undertake licensable activities (ie. Manufacture, package, label or import) unless they have a valid site licence. The NNHPD acknowledges that some sites may not start activities immediately upon receiving a site license or may suspend operations temporarily once they have started. With the publication of service standards for the review of site licence applications by NNHPD, applicants can now plan their business accordingly when it comes to obtaining and renewing their site licence.

As such, companies will be required to submit with their renewal package records from within the previous 12 months that demonstrate their ability to comply with Part 3 - GMP - of the Regulations. 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 GMP, will see their application for renewal refused. A new application will be required prior to initiating or resuming activities.

As per the summary of service standards for the management of site applications table 1 in chapter 3.1.1, complete applications which include only pre-cleared  evidence of GMP compliance for every site, as described in Chapter 2.1.1. will receive a decision regarding their applications for renewal within thirty (30) business days from the date of acknowledgement.

Complete applications which include a SNC as evidence of GMP compliance for one or more sites will receive a decision regarding their applications for renewal within sixty (60) business days from the date of acknowledgement. For such applications including 10 or more sites, up to an additional thirty (30) business days may be required for assessment, depending on the complexity and type of supporting information provided for each site.

4.2 Site licence amendment

Section 32 of the Regulations defines changes that require a site licence amendment. The licensee shall not be permitted to conduct any activities relating to the amendments until the site licence is amended by the NNHPD.

Part 2: Site Licences
Amendment
Section 32

  1. A licensee shall not conduct any of the following activities unless the site licence is amended accordingly:
    1. conduct any activity for which a site licence is required that the licensee is not already authorized to conduct;
    2. if the licensee is authorized to manufacture, package or label a natural health product, conduct that activity in a building that is not one in which the conduct of that activity is authorized;
    3. if the licensee is authorized to import a natural health product, store a natural health product in a building that is not one in which the storage is authorized; or
    4. if the licensee is authorized to conduct an activity, but not already authorized to conduct it in respect of a natural health product in sterile dosage form, conduct the activity in respect of a natural health product in that form.

  2. An application to amend a site licence shall be submitted to the Minister and shall contain the following information and documents:
    1. the licence number;
    2. a statement that specifies each activity referred to in subsection (1) that the licensee is proposing to conduct; and
    3. a report from a quality assurance person demonstrating that the buildings, equipment, practices and procedures used in respect of each activity conducted by the licensee will remain in compliance with the requirements set out in Part 3.

An amendment is required for one or more of the following changes to a site licence:

  • Adding a new activity.
  • Adding a new building for manufacturing, packaging, labelling or storage.
  • Changing from manufacturing, packaging, labelling, or importing a non-sterile dosage form to sterile dosage form.
  • Adding a new foreign site.

When the licensee seeks an amendment to a site licence, he or she must provide an application for amendment containing the following information:

  • The SLA form indicating the site licence number and the amendment being requested (e.g. new building, site, or activity that the licensee is proposing to conduct); as well as evidence of GMP compliance to support any new activities or sites. Acceptable types of evidence of GMP compliance are described in Chapter 2.0.

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.

As per the summary of service standards for the management of site applications table 1 in chapter 3.1.1., complete applications which include only pre-cleared evidence of GMP compliance for every site being amended, will receive a decision regarding their site licence amendment within thirty (30) business days from the date of acknowledgement

Complete applications which include a QAR as evidence of GMP compliance for one or more sites being amended will receive a decision regarding their site licence amendment within sixty (60) business days from the date of acknowledgement. For such applications including amendments to 10 or more sites, up to an additional thirty (30) business days may be required for assessment, depending on the complexity and type of supporting information provided for each site.

Relinquishment of authorization

Section 38 of the Regulations describes how a licensee may relinquish any part of the authorization given to that licensee. A licensee may request an amendment to delete or relinquish part of the site licence authorization, such as the removal of a building due to its sale, or if a company ceases to perform one of its authorized functions (e.g. packaging or labelling).

Part 2: Site Licences
Relinquishment of Authorization
Section 38

  1. A licensee may, by amendment of the site licence, relinquish any part of the authorization given to the licensee under this Part.

  2. An application to amend the site licence for the purposes of subsection (1) shall be submitted to the Minister and shall contain the following information and documents:
    1. a document, signed and dated by the licensee, that sets out the site licence number and that specifies each activity or, by address, each building, in respect of which the authorization is requested to be relinquished; and
    2. an attestation, signed and dated by a quality assurance person, stating that after the relinquishment, the buildings, equipment, practices and procedures used in respect of each activity conducted by the licensee will remain in compliance with the requirements set out in Part 3.

  3. The Minister shall amend the site licence as requested by the licensee in paragraph (2)(a) if the licensee provides the Minister with an application that is in accordance with subsection (2).

To do this, the licensee must submit an amendment submission including the site licence application form, which is signed and dated by the person who originally signed the application or the licensee's senior signing official. The application form must also include the licence number; the specific building or activity that is being surrendered; and an attestation signed and dated by the quality assurance person stating that after surrendering the licensed building or activity, other activities and buildings still comply with Part 3, GMP, of the Regulations.

4.3 Site licence notification

Section 33 of the Regulations defines those changes that require a site licence notification. Licensees must notify the NNHPD within sixty (60) calendar days after a change in any of the following information contained in their original submission:

  • A change in the name, mailing address, telephone number, facsimile number or e-mail address.
  • Any substantial change that alters any building, equipment, practice or procedure.

Part 2: Site Licences
Notification
Section 33

If the licensee makes any of the following changes, the licensee shall notify the Minister of the change within 60 days after the day on which the change is made:

  1. a change to the information submitted under paragraph 28(a); and
  2. a change that substantially alters any building, equipment, practice or procedure in respect of which a report from a quality assurance person was submitted under paragraph 28(f).

When notifying the NNHPD of changes related to contact information (name, address, telephone number etc.), the licensee must provide a revised copy of the site licence application form indicating the changes. When notifying the NNHPD of changes related to the building, equipment, practices or procedures, the licensee must provide a completed notification form, along with the revised site licence application form indicating the changes. Site licensing forms can be found on the Health Canada website.

Notifications will be examined for completeness. Complete applications complying with the requirements above, will receive a revised SL (if required) within fifteen (15) business days.

4.4 Site licence suspension and cancellation

Sections 39 to 42 of the Regulations outline the reasons and procedures by which a site licence may be suspended or cancelled.

Part 2: Site Licences
Suspension and Cancellation
Section 39

  1. Subject to subsection (2), the Minister may suspend a site licence if the Minister has reasonable grounds to believe that
    1. the licensee has contravened any provision of the Act or these Regulations; or
    2. the licensee has made a false or misleading statement in the application submitted under section 28 or the application for amendment under subsection 32(2).

  2. Subject to section 40, the Minister shall not suspend a site licence unless
    1. the Minister has sent the licensee a notice that sets out the reason for the intended suspension; and
    2. the licensee has not, within 90 days after the day on which the notice referred to in paragraph (a) is received, provided the Minister with information or documents demonstrating that the licence should not be suspended on the grounds that
      1. the situation giving rise to the intended suspension did not exist, or
      2. the situation giving rise to the intended suspension has been corrected.
 

Part 2: Site Licences
Suspension and Cancellation
Section 40

The Minister shall suspend a site licence before giving the licensee an opportunity to be heard if, as a result of any circumstance, the Minister has reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a purchaser or consumer.

 

Part 2: Site Licences
Suspension and Cancellation
Section 41

If the Minister suspends a site licence under section 39 or 40, the Minister shall send the licensee a notice that sets out the reason for suspension and the day on which the suspension is effective, and the Minister shall

  1. reinstate the licence if, within 90 days after the day on which the suspension is effective, the licensee provides the Minister with information or documents demonstrating that the situation giving rise to the suspension did not exist or that it has been corrected; or
  2. cancel the licence if, within 90 days after the day on which the suspension is effective, the licensee has not provided the Minister with the information or documents referred to in paragraph (a).

 

Part 2: Site Licences
Suspension and Cancellation
Section 42

If the Minister cancels a licence under paragraph 41(b), the Minister shall send the licensee a notice that sets out the reason for the cancellation and the day on which the cancellation is effective.

The NNHPD may suspend a site licence under any of the following circumstances:

  • The licensee is found to have contravened the Regulations or any provision of the Food and Drugs Act.
  • The licensee is found to have made a false or misleading statement in the site licence application or application to amend the site licence.
  • The NNHPD has enough evidence to believe that it is necessary to suspend the licence to prevent injury to the health of purchasers or consumers.

If it is necessary to prevent injury to the health of consumers, a suspension may be immediate. Otherwise, the NNHPD will send the licensee a notice of its intent to suspend indicating the reason for the suspension. The licensee will have ninety (90) calendar days to respond from the date of issuance of the notice with the following:

  • Evidence that the situation that led to the intended suspension has been rectified; or
  • Evidence demonstrating that the situation giving rise to the intended suspension does not exist.

If the licensee does not submit this information to the NNHPD within ninety (90) calendar days, the licence may be suspended. If the NNHPD suspends a site licence, a notice of suspension, setting out the reason(s) for the suspension will be sent to the licensee. The NNHPD will reinstate the licence if, within ninety (90) calendar days of the effective date of suspension, the licensee provides the NNHPD with evidence demonstrating that the situation giving rise to suspension did not exist or has been corrected.

If within ninety (90) calendar days of the effective date of suspension, the licensee does not provide the NNHPD with information demonstrating that the situation giving rise to the suspension has been corrected, the licence will be cancelled. If the NNHPD cancels the site licence, a notice of cancellation, setting out the reason(s) and effective date of cancellation, will be sent to the licensee.

No manufacturer, packager, labeller, or importer may conduct any activity authorized by the site licence while the licence is suspended and/or after it is cancelled. Once a licence is cancelled, manufacturers, packagers, labellers or importers must submit an application for a new site licence demonstrating compliance with Part 3, GMP, of the Regulations and be issued a new site licence before conducting any NHP related licensable activities.

Licensees have the right to request decisions relating to the suspension or cancellation of a licence be reconsidered. For more information, contact the Submissions Management Division of the NNHPD at NNHPD_DPSNSO@hc-sc.gc.ca.

 

5.0 How to submit a general site licence inquiry and remain informed

For questions specific to a submission, please contact the assigned Site Licence Assessment Officer. General inquiries relating to the submission process or site licensing requirements may be submitted by email to NNHPD_DPSNSO@hc-sc.gc.ca.

The NNHPD also has a Really Simple Syndication (RSS) feed on the Health Canada website to help inform stakeholders of the latest web-related activities and postings; including updates regarding workshops, new documents, new initiatives or other information deemed relevant for NHP applicants. Once stakeholders have signed up for NNHPD's RSS feed, they will be alerted via RSS reader of new postings. Applicants are encouraged to sign up on the Health Canada website for the RSS feed.

 

6.0 Glossary

The definitions given below apply to the terms used in this guidance document. Certain terms may have different meanings in other contexts.

Acknowledgment Notice
A letter issued to all applicants to confirm the receipt of their application. The acknowledgment Notice includes the file number, transaction number and date or receipt of application and request for clarity to company information, if required.
Building
A place where a licensable activity or storage is being or has been conducted. It is one location at the same address.
Distributor
A person who sells a natural health product to another person for the purpose of further sale.
Dosage form
The final physical form of the natural health product which may be used by the consumer without requiring any further manufacturing.
Drug establishment licence (DEL)
A DEL is a licence issued to a person in Canada allowing them to conduct licensable activities in a building which has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations.
Education
The act or process of imparting or acquiring knowledge or skills, and the learning of information by instruction, training or study, which can be testified to by a degree, certificate or diploma.
Experience
Active participation in events or activities leading to the acquirement of knowledge or skills; the knowledge or skills retained from personally observing, encountering or undergoing something.
File number
A number assigned by the Natural and Non-prescription Health Products Directorate (six digits) to the original submission which will be maintained to track all subsequent applications to the initial submission.
Foreign Site Reference Number Authorization Form
An authorization form completed by a foreign site Senior Official (who maintains a valid foreign site reference number) that is used to support an importers site licence application.
Good manufacturing practices (GMP)
Measures to ensure an overall effective approach to product quality control and risk management. They apply to places, people, processes and products with respect to which activities are being conducted. Please refer to Part 3 of the Natural Health Products Regulations and the Good Manufacturing Practices guidance document.
Homeopathic medicine
Medicines that are manufactured from or contain as medicinal ingredients only those substances or sources referenced in the Homeopathic Pharmacopoeia of the United States, the Hom÷opathische Arzneibuch, the PharmacopÚe franšaise or the European Pharmacopoeia, as amended from time to time, and that are prepared in accordance with these pharmacopoeias.
Import
To bring into Canada a natural health product for the purpose of sale.
Importer
A person who imports a natural health product into Canada for the purpose of sale. This would include bulk natural health products.
Information Request Notice (IRN)
A notice issued to request additional information related to the submission that is required as per sections 15, 37 or 73 of the Natural Health Products Regulations.
Manufacture
To fabricate or process a product for the purpose of sale.
Manufacturer
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 a patient, compounds a natural health product for the purpose of sale to that patient.
Natural health product (NHP)
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, a homeopathic preparation or a traditional medicine that is manufactured, sold or represented for use in:
  • diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state or its symptoms in humans;
  • restoring or correcting organic functions in humans; or
  • modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
However, a natural health product does not include a substance set out in Schedule 2, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2. (in French produit de santÚ naturel)
Notice of cancellation of licence
As per section 42 of the Natural Health Product Regulations, a notice is issued to inform a company that their site licence has been cancelled. This is issued when corrective action is not taken within ninety (90) days of the date the site licence was suspended as per section 41(b) of the Natural Health Products Regulations.
Notice of intent to suspend a licence
As per section 39 of the Natural Health Product Regulations, a notice is issued to inform a company of intent to suspend a licence if the Minister has reasonable grounds to believe that the licensee has contravened any provision of the Act or these Regulations, or the licensee has made a false or misleading statement in the application submitted under section 28 or the application for amendment under subsection 32(2) of the Natural Health Products Regulations.
Notice of suspension of licence
As per section 41, a notice issued to inform the company that their site licence has been suspended, when the licensee fails to take corrective action within ninety (90) calendar days of receiving the notice of intent to suspend.
Package
Includes immediate container in which any food, drug, cosmetic or device is wholly or partly and directly contained, placed or packed.
Qualification
Requirement to be eligible for an office, position, or task by having the proper or necessary skills, knowledge, credentials, accomplishments or qualities.
Qualified authority
An authority member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), or country where Health Canada has a Mutual Recognition Agreement (MRA) regarding GMP for drug products.
Quality assurance person
The person who is responsible for assuring the quality of a natural health product before it is made available for sale. This person has the training, experience and technical knowledge relating to the specific activity conducted for a given building/site (e.g. manufacturing, packaging, labelling, and importing) and fulfills the requirements of Part 3 of the NHPD.
Quality Assurance Report
A report prepared by a quality assurance person who meets the requirements with respect to education, training, and experience according to section 51(a) (ii) of the. This report is based on the assessment against the good manufacturing practices regulations and requirements set out in the good manufacturing practices guidance document. It is considered a self-assessment document and evidence of good manufacturing practices compliance.
Raw material
Any substance, other than in-process product or packaging material, intended to be used in the manufacture of products, including those that appear in the master formula but that do not appear in the product such as solvents and processing aids.
Sell (section 2 of the Food and Drugs Act). Sell includes offer for sale, expose for sale, have in possession for sale and distribution, regardless of whether the distribution is made for consideration.
Site
A place of or for an activity specified under the Natural Health Product Regulations.
Site licence application
A request for authorization to manufacture, package, label, and/or import a natural health product.
Site licence number
A number issued by Health Canada's Natural and Non-prescription Health Products Directorate based on the requirements set out in the Natural Health Products Regulations as proof of authorization to conduct specified activities at the listed locations.
Sterile dosage form
A dosage form that is free from viable microorganisms.
Submission number
A number assigned by the Natural and Non-prescription Health Products Directorate (six digits) to distinguish between different submissions within the same file (i.e. an amendment to a site licence would have the same file number as the original submission but a new submission number).
Submission Receipt Acknowledgement Notice
A notice issued to confirm receipt of submission. The notice includes the application type, company code, file number and submission number, and the date of receipt. Applicants must reference the submission and file numbers assigned on all subsequent correspondence about the particular submission.
Summary of Net Changes Form
A form indicating a summary of any changes that may have taken place with respect to a site since the last application that was provided to the NNHPD.
 

Appendix A: Obtaining a foreign site reference number

What is a foreign site reference number?

A Foreign Site Reference Number (FSRN) is issued by the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada to a manufacturer, packager and/or labeller of NHPs located outside of Canada, referred to as a foreign site.A FSRN indicates that the foreign site is found to be in compliance with Part 3, Good Manufacturing Practices (GMP), of the Next link will take you to another Web site Natural Health Products Regulations (the Regulations).

The FSRN application process will benefit foreign sites by:

  • Allowing direct communication between Health Canada and the foreign site, maintaining confidentiality of the information provided;
  • Saving time, money and resources for foreign sites engaged with multiple Canadian importers by eliminating the need to supply the site GMP information to each importer several times a year. The FSRN is valid for a period of one year or three years depending on the type of supporting GMP evidence provided in the application;
  • Assessing the GMP compliance of a foreign site in advance, will also benefit the importer's subsequent site licence application. A FSRN is considered pre-cleared evidence when referenced in support of an importer's site licence applications, and is therefore subject to a shorter service standard as per section 3.1.1 of this guide.

In order to obtain a FSRN, applicants must provide a FSRN application to the NNHPD (Chapter 2.0). The application must be accompanied by acceptable evidence of GMP compliance to adequately demonstrate the foreign site's ability to manufacture, package and/or label NHPs in accordance with the requirements outlined in Part 3 of the Regulations.

To maintain the status of the FSRN, FSRN holders must renew, amend their foreign site information, and notify the NNHPD of any changes to the information indicated in their original application as outlined in Chapter 4 for renewals (4.1), amendments (4.2), and notifications (4.3) process for site licence applications.

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.

Applying for a foreign site reference number

The FSRN application process requires foreign sites to supply the same types of evidence of GMP compliance as Canadian manufacturers, packagers and labellers in support of their application.

To apply for a FSRN, applicants must provide an application to the NNHPD which includes the following forms and documents:

  1. Foreign Site Reference Number (FSRN) application form: The Foreign Site Reference Number application form captures all of the required information related to the company and contact person.
  2. Designated Party Authorization (DPA) form (when applicable): Applicants who have designated a third party person to file a submission with the NNHPD on their behalf must submit a Designated Party Authorization form. This form must be resubmitted with each application and/or if the designated party should change at any time.
  3. Evidence of GMP compliance for the site. See Chapter 2.1 for acceptable evidence types.

Required forms related to the application process can be found on the Health Canada website.

Foreign site reference number applications, renewal, amendment and notifications with their respective attachments should be submitted to the NNHPD according to the instructions indicated in Chapter 2.2.

Submission management and decision

Chapter 3.0 describes the processing and assessment process for site licence applications. Although foreign sites do not receive a site licence, the same process applies to a new FSRN, renewal, amendment or notification submitted. It also outlines the responsibilities and expectations of the applicant before and throughout the application review process.

Based on the information submitted, the NNHPD will recommend the issuance or refusal of a FSRN.

As described in Chapter 3.1.1., complete applications which include pre-cleared evidence will receive a decision regarding their FSRN application within thirty (30) business days from the date of acknowledgement. FSRN issued based on pre-cleared evidence will be valid for a period of 3 years from the date of issuance.

Complete applications which include a QAR as evidence of GMP compliance will receive a decision regarding their FSRN application within sixty (60) business days from the date of acknowledgement. FSRN issued based on QAR will be valid for a period of 1 year from the date of issuance.

Foreign site reference number issuance

The NNHPD will only issue or amend a FSRN when the applicant has provided a complete submission with all the required supporting information to assess whether the site is compliant with the Regulations.

The FSRN notice of acceptance contains the assigned reference number, the name and address of the FSRN holder, applicable activities, and the address of the building in which the FSRN holder is authorized to conduct that activity. A copy of the FSRN notice of acceptance will be sent to the Senior Official indicated in the application. FSRN holder information is also posted publicly on the Health Canada website.

Note: It is possible that certain sections of the Regulations (e.g. section 44 Specification, section 52 Stability and/or section 61 Lot or Batch Samples) may be found to be deficient or not fully compliant with Part 3 of the Regulations. In this case, a foreign site may still be issued a reference number; however, the FSRN notice of acceptance will clearly identify the sections that must be addressed by the Canadian importer in order to satisfy the GMP requirements of the site.

Refusal to issue a foreign site reference number

The NNHPD may refuse to issue or renew a FSRN or amend FSRN information when the site is not compliant with the GMP requirements set out in Part 3 of the Regulations, when it finds the application to be deficient, when the applicant does not provide additional information on request, or when the information submitted is false or misleading. When a FSRN application is refused, the NNHPD sends the applicant a notice stating the reasons for refusal.

Using a foreign site reference number

Once the foreign site has been issued a reference number, it can be used immediately to support an importer's site licence application. All foreign sites to which NHPs are imported from must be listed on the importer's site licence. The FSRN is not an authorization for direct export of NHPs into Canada. The FSRN holder will engage in a partnership with a licensed Canadian importer in order to export NHPs into Canada. The FSRN authorization will be considered as evidence of GMP compliance for the foreign site when provided to support the importer's application.

Foreign site reference number authorization form

For each application, the FSRN holder should provide each Canadian importer with a completed Foreign Site Reference Number Authorization Form, available on the Health Canada website. A separate authorization form must be provided to each importer since the information captured in the form will be specific to the business arrangement between the two companies. The authorization form allows the NNHPD to access the previously assessed GMP information for the foreign site in support of any application submitted by the importer.

The importer, in turn, will provide the authorization form to the NNHPD as part of their new site licence, renewal or amendment application. The importer must also provide GMP records for any section of the Regulations identified as incomplete in the FSRN notice of acceptance (as described under Foreign Site Reference Number Issuance) in their application.

The FSRN holder can provide an authorization form to an unlimited number of Canadian importers as long as the reference number remains valid. A new authorization form should be provided to importers when required, since the FSRN must be renewed each year or every three years depending on the type of GMP evidence that was provided.

Foreign site reference number expiry and renewal

A FSRN will expire one year after the date of issuance if a QAR was provided as GMP evidence.

A FSRN will expire three years after the date of issuance if pre-cleared GMP evidence was provided.

In order to maintain the status of a FSRN, the applicant must submit a renewal application in sufficient time to the NNHPD based on the summary of service standards for the management of site applications outlined in Table 1.

The FSRN holder will submit an application to the NNHPD to renew its FSRN along with acceptable evidence of GMP compliance. Acceptable evidence of GMP compliance for a renewal can be found in Chapter 4.1. An application for a FSRN renewal must be received by the NNHPD at least thirty (30) days prior to the expiry date. In the case where an application is not received within the required timeframe, the FSRN will no longer be valid. If the FSRN holder wishes to regain a FSRN, a new application must be provided to the NNHPD.

Foreign site reference number amendment and notification

This section describes the requirements and processes a FSRN holder must follow to apply for a amendment and/or a notification to their FSRN information. Processing timelines for amendments and notifications can be found in Chapter 3.1.1.

An amendment is required for one or more of the following changes to a foreign site:

  • Adding a new activity.
  • Relocation of a site (change of address).
  • Changing from manufacturing, packaging, or labelling a non-sterile dosage form to sterile dosage form.

When the FSRN holder seeks an amendment to foreign site information, he or she must provide an application for amendment containing the following information:

  • The FSRN application form indicating the reference number and the amendment being requested (e.g. new building/ address, or activity that the FSRN holder is proposing to conduct); as well as evidence of GMP compliance to support any new activities or sites.

The FSRN holder must notify the NNHPD within sixty (60) calendar days of a change in any of the following information contained in their original submission:

  • A change in the name, mailing address, telephone number, facsimile number or e-mail address.
  • Any substantial change that alters any building, equipment, practice or procedure

When notifying the NNHPD of changes related to business information (name, address, telephone number etc.), the FSRN holder must provide a revised copy of the FSRN application form indicating the changes.

When notifying the NNHPD of changes related to the building, equipment, practice or procedure, the licensee must provide a completed notification form, along with the revised FSRN application form indicating the changes. Forms can be found on the Health Canada website.

Foreign site reference number cancellation

The NNHPD may cancel a FSRN at any time under any of the following circumstances:

  • The FSRN holder is found to have contravened the Regulations or any provision of the Food and Drugs Act;
  • The FSRN holder is found to have made a false or misleading statement in the FSRN application; or
  • The NNHPD has enough evidence to believe that it is necessary to cancel the FSRN to prevent injury to the health of purchasers or consumers.

If the NNHPD cancels a FSRN, a notice of cancellation, setting out the reasons and effective date of cancellation, is sent to the FSRN holder. All Canadian importers who have that site on their site licence will also be contacted. Canadian importers will not be permitted to import NHPs from a foreign site using a FSRN Authorization Form after the cancellation of the FSRN.