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Management of Product Licence Applications (PLA) For Natural Health Products
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(PDF Version - 81 K)August 2010
Table of Contents
- 1. Purpose
- 2. Scope
- 3. Before Filing Product Licence Applications
- 4. Filing of Product Licence Applications
- 5. Communicating With the Natural Health Products Directorate (NHPD) Regarding Product Licence Applications
- 6. Pre-Submission Meetings
- 7. Administrative Processing
- 8. Application Assessment for Applications Fully Meeting Pre-Cleared Information
- 9. Application Assessment for Applications Requiring Full Assessment of Safety, Efficacy and/or Quality Information
- 10. Application-Full Assessment
- 11. Reviewers' Reports
- 12. Unsolicited Information
- 13. Re-Filed Applications
- 14. Request for Reconsideration
1. Purpose
The purpose of this policy is to outline the way the Natural Health Products Directorate (NHPD) will manage Product Licence Applications for natural health products submitted in accordance with the Natural Health Products Regulations. The policy also outlines the responsibilities and expectations for natural health product applicants before and throughout the application review process.
This policy is effective as of the date of publication for any applications received after that date.
2. Scope
This policy applies to all natural health product application types as follows:
Applications meeting pre-cleared information:
- Abbreviated Labelling Standards (AbLS)
- Amendments (referencing pre-cleared information)
- Compendial (Monographs)
- Labelling Standards
Applications requiring full assessment of safety, efficacy and / or quality information:
- Amendments for a Significant Change requiring assessment of Safety, Efficacy and / or Quality
- Homeopathic
- Non-Traditional
- TPD Category IV Monographs/ Labelling Standards (containing NHP ingredients)
- Traditional
All applications will be examined for completeness and suitability for review. In addition, subsequent solicited or unsolicited information will be subjected to a screening process. All information and data submitted in support of a PLA will be retained by Health Canada.
3. Before Filing Product Licence Applications
3.1 Ingredients
The applicant must ensure that the medicinal ingredients contained in the product are natural health product ingredients in accordance with Schedules 1 and 2 of the Natural Health Products Regulations. All medicinal and non-medicinal ingredients found in the product must be listed as such within the Natural Health Products Ingredients Database (NHPID). Please note that some ingredients within the NHPID have associated limits or restrictions and these must also be considered when filing. In addition, the NHPID also lists some ingredients which are not natural health product ingredients and those are clearly indicated as not acceptable. An entry in the database does not imply that the ingredient has been reviewed for safety.
If these ingredients are not listed in the NHPID, applicants are responsible for submitting a request to NHPD to add these ingredients to the database before the application is filed. The application can only be filed once the ingredients are deemed acceptable and added to the database.
Applicants must also ensure that the dosage form, route of administration and non-medicinal ingredient purposes for the product are recognized by NHPD and therefore found within the NHPID.
For more information on how to request the addition of ingredients or other information to the NHPID, please see the Natural Health Products Ingredients Database Issue Form.
3.2 Trading Partner Agreement
If applicants wish to submit applications and supporting documents via NHPD's secure email service - PosteCS™, they must first enrol as a trading partner with NHPD.
Note: PosteCS is a service that is only available to Canadian companies. Applicants from outside of Canada are still encouraged to submit electronic applications to NHPD, either through a Canadian representative who has an established Trading Partner Agreement or on CD or DVD. Please see, Section 4.2 below.
For more information on how to enrol as a trading partner, please see the Natural Health Products Online Solution.
4. Filing of Product Licence Applications
Please note that it is the intent of NHPD that the e-PLA will be the only form accepted in the future. NHPD cannot commit to the performance targets outlined in this document for applications received in any other format and applicants should expect a substantial increase in processing time. Currently, NHPD accepts both electronic and paper versions of the e-PLA and continues to accept paper versions of the original PLA; however, this section is focused on the e-PLA. The e-PLA provides several benefits to both applicants and NHPD which include:
- Reduces possibility of the application being rejected / refused due to embedded rules and checks for specific regulatory requirements
- Eliminates duplication of manual entry of product information
- Reduces mail / courier costs
- Reduces paper use
4.1 Filing of electronic Product Licence Applications (e-PLA) by secure email
NHPD strongly encourages applicants to file Product Licence Applications, amendments, notifications and responses to Information Request Notices (IRN) electronically via NHPD's secure email service - PosteCS™. In order to use PosteCS™, applicants must be enrolled as a Trading Partner. For more information on how to enrol as a Trading Partner, please see section 3.2 above.
4.2 Filing of electronic Product Licence Applications (e-PLA) on CD or DVD
Although applicants are strongly encouraged to enrol as Trading Partners and submit applications via NHPD's secure email service - PosteCS™ - as mentioned in section 4.1 above, it is also possible to submit the e-PLA and supporting documents by mail or courier. If submitting by mail or courier, applicants are encouraged to submit a CD or DVD containing the e-PLA and all supporting documents.
Applications submitted by mail or courier may be sent to:
Health Canada
Health Products and Food Branch
Natural Health Products Directorate
Bureau of Product Review and Assessment
Submission Management Division
Basement, Qualicum, Tower A
2936 Baseline Rd.AL 3300C, Ottawa, ON
K1A 0K9, Couriers: K2H 1B3
4.3 Filing of electronic Product Licence Applications (e-PLA) in paper format
If applicants cannot submit through NHPD's secure email service - PosteCS™ - and cannot submit applications and supporting documents on CD or DVD, the e-PLA and supporting documents can be printed and submitted by mail or courier. When completed, the e-PLA will generate a bar-code which can be scanned by NHPD to extract the data electronically. The capture of this data requires an extra step by NHPD staff and therefore delays the processing of the application. Therefore, applicants are encouraged to submit applications as described in sections 4.1 and 4.2 above.
Applications submitted by mail or courier can be sent to the address indicated in section 4.2 above.
5. Communicating With the Natural Health Products Directorate (NHPD) Regarding Product Licence Applications
5.1 Natural Health Product Directorate (NHPD) email distribution list (commonly known as BEEP messages)
By providing an email address within Part 1 of the PLA form, applicants are automatically included on NHPD's email distribution list and will receive updates regarding workshops, new documents (i.e. pre-cleared information), new initiatives or other information deemed relevant for NHP applicants.
5.2 Submission Coordinators
Each PLA is assigned a Submission Coordinator at NHPD. Submission Coordinators provide assistance and advice regarding the Natural Health Products Regulations and PLA review at NHPD. This includes advice regarding regulatory notices or decisions issued by NHPD, policies, guidance, procedures, tools, and initiatives. Notices sent to applicants usually include the name of the assigned Submission Coordinator; this information can also be found by contacting PLA.info.DLMM@hc-sc.gc.ca which is the email account managed by the Product Licence Application Submission Coordinators.
6. Pre-Submission Meetings
Applicants may wish to deliver a brief presentation to the NHPD prior to submitting a Product Licence Application (PLA). The purpose of pre-submission meetings is to discuss the presentation of evidence in support of the application. In addition, such meetings:
- familiarize assessment staff with the forthcoming application prior to its arrival, and provide a forum to discuss the evidence in the application to facilitate its assessment;
- have the potential to uncover any major unresolved problems or issues and manage disputes early in the application process;
- establish which studies the applicant is relying on to support the efficacy of the natural health product and discuss the adequacy and appropriateness of controls;
- provide an opportunity for the applicant to discuss details of the application with the NHPD and obtain feedback regarding any areas of concern based on current experience and regulatory requirements; and,
- provide NHPD the opportunity to re-align resources, if necessary, to accommodate the arrival of the application.
Best practices will be followed to ensure meetings are well-organized, efficient, productive, and properly documented.
6.1 Meeting Requests
Meeting requests are to be submitted to the same address as identified above in section 4 or by email to PLA.info.DLMM@hc-sc.gc.ca. Requests are to be made no less than 1 month prior to the proposed meeting date and should include the following information:
- the purpose of the meeting
- a brief description of the product to be discussed at the meeting
- three proposed dates for the meeting
In order to ensure efficient use of NHPD resources, requests should include adequate information to determine the utility of the meeting and to identify appropriate staff necessary to discuss proposed issues.
6.2 Pre-Submission Packages
Applicants will be requested to submit a pre-submission meeting information package at least 2 weeks in advance of the meeting. Packages should contain the following information:
- a cover letter
- an agenda for the meeting
- a list of specific issues the applicant would like to discuss or have addressed
- a brief summary of the natural health product for which the meeting is being called
- proposed strengths and dosages
- an overview of the market history of the product including the foreign regulatory status of the product
- identification of the indication(s) for which authorization is sought
- brief summaries of the safety and efficacy data relating to the product
7. Administrative Processing
All applications will be examined for administrative completeness. The NHPD will target to complete this examination within ten (10) calendar days of receipt in the Directorate.
7.1 Acceptable Applications
Applications meeting the administrative requirements will be forwarded for subsequent review or in some cases, for an initial assessment of the safety, efficacy and quality evidence in support of the product(s).
7.2 Unacceptable Applications
Applications that are deficient with respect to administrative content will result in the issuance of a Rejection Notice - Administrative Deficiency. The Directorate will target to issue these letters within ten (10) calendar days after completing the examination of the application.
8. Application Assessment for Applications Fully Meeting Pre-Cleared Information
8.1 Application Assessment
Applications fully meeting pre-cleared information include: Compendial Applications (Monographs), Abbreviated Labelling Standard (AbLS) Applications, Labelling Standard Applications and Amendment Applications (referencing pre-cleared information)
The NHPD will target to have the above-mentioned application types assessed and a Product Licence (PL) issued within fifty (50) calendar days following the Administrative Processing step.
If deficiencies are identified during the assessment of these applications, an Application Refusal Letter will be issued to the applicant. If the applicant wishes to re-submit the application at a future time, it will be processed as a new application.
8.2 Refusal Letters
An applicant may request a reconsideration of the decision by the Directorate to refuse their application by following the steps outlined in the NHPD=s Reconsideration Process. For more information on NHPD's Reconsideration Process, please see section 14.
9. Application Assessment for Applications Requiring Full Assessment of Safety, Efficacy and/or Quality Information
9.1 Application Assessment
Applications requiring full assessment of safety, efficacy and / or quality include: Non-Traditional Applications, Traditional Applications, Homeopathic Medicine Applications and Amendment Applications for a Significant Change requiring assessment of Safety, Efficacy and / or Quality. These applications may partially reference information that has been pre-cleared by NHPD but still require some assessment.
These applications will be subject to screening against minimum application requirements as outlined in NHPD's Product Licensing guidance document. In addition, these applications will be subject to an initial assessment of the evidence in support of safety, efficacy and quality to ensure that the requisite information for the type of application in question, as defined in the Natural Health Product Regulations and as described in various guidance documents has been submitted.
The Directorate will target to have the above-mentioned application types assessed for completeness of evidence within twenty (20) calendar days of receipt following the Administrative Processing step. An Application Acceptance Letter will be issued by the Directorate when the information and material submitted are deemed complete and are acceptable for full assessment.
If deficiencies are identified during the initial assessment, a Refusal Letter - Initial Assessment will be issued to the applicant for failure to provide a complete application.
9.2 Refusal Letters
An applicant may request a reconsideration of the decision by the Directorate to refuse their application by following the steps outlined in the NHPD=s Reconsideration Process. For more information on NHPD's Reconsideration Process, please see section 14.
10. Application-Full Assessment
Upon issuance of an Application Acceptance Letter, applications will enter the assessment queue of the Product Assessment Division of the Bureau of Product Review and Assessment. The Managers of the Division are responsible for managing Division workload and assigning new work items to their staff, taking into account performance targets.
The review target for applications for Non-Traditional Claims, Traditional Claims, Homeopathic Medicines and Amendments for a Significant Change requiring assessment of Safety, Efficacy and / or Quality is ninety (90) calendar days from the date of the Application Acceptance Letter.
10.1 Full Assessment-Information Request Notices
At any point in the assessment process, significant deficiencies or information omissions that preclude the ongoing review of a Product Licence Application or Licence Amendment may be transmitted to the applicant in a Refusal Letter. However, in most instances, NHPD will provide the opportunity for the applicant to address deficiencies or information omissions by through an IRN. These letters will be issued by the Submission Management Division of the Bureau of Product Review and Assessment. The applicant will be given thirty (30) calendar days from the date of the letter in which to submit the requested information in question and answer format. For the purpose of implementing and maintaining an efficient assessment process, the Division will target to issue one comprehensive IRN. In certain situations a second IRN may be issued.
If the response is considered to be complete, a new forty-five (45) calendar day assessment period will begin. The NHPD reserves the right to request clarification of the information submitted.
10.2 Refusal Letters
A Refusal Letter will be issued by the Director, Bureau of Product Review and Assessment in the following circumstances:
- failure to meet the requirements of the Natural Health Product Regulations or any provisions of the Act, after a comprehensive assessment; or
- failure to submit the requested information in response to an IRN within the thirty (30) calendar days specified, or submission of an incomplete or deficient response to the IRN
The Refusal Letter will contain the specific reasons or deficiencies that resulted in the decision to refuse issuance or amendment of a Product Licence. All decisions to refuse an application are without prejudice to re-filing. If an applicant wishes to resubmit an application at a future time, the application will be processed as a new application. Information and data submitted to support the original application will not be returned to the applicant. Such data may be cross-referenced only if re-filing of the new application occurs within six (6) months of the date of the Refusal Letter.
An applicant may request a reconsideration of the Directorate=s decision to refuse their application in accordance with the NHPD Reconsideration Process. For more information on NHPD's Reconsideration Process, please see section 14.
10.3 Withdrawal Letters
At any time during the review of their application, an applicant may withdraw their application by informing the Bureau of Product Review and Assessment of their intent via email or fax. Applicants can send this information by email to PLA.info.DLMM@hc-sc.gc.ca, by fax to (613) 954-2877 or directly to their Submission Coordinator via email. All withdrawal letters will be acknowledged in writing by the bureau. The status of the application will be recorded as "withdrawn by applicant".
Withdrawal of an application is without prejudice to re-filing. If an applicant wishes to resubmit an application at a future time, the application will be processed as a new application. Information and data submitted to support the original application will not be returned to the applicant. Such data may be cross-referenced only if re-filing of the new application occurs within six (6) months of the date of withdrawal.
11. Reviewers' Reports
Following receipt of a Refusal Letter as a result of Full Assessment, an applicant may request reviewers= reports by writing to the Director, Bureau of Product Review and Assessment and referencing the Submission number. The Bureau will target to provide a copy of the requested reports to the applicant within fifteen (15) calendar days from receipt of the request.
12. Unsolicited Information
12.1 Information which can be submitted at any time
Applicants are encouraged to submit at any time during the assessment, information to supplement or correct information on the regulatory status of the product in other countries, problem reports impacting the safety or efficacy of the product submitted to other Regulatory Agencies, and safety information enhancing the safe use of the natural health product, including updated safety-related labelling. The submission of such information does not include significant changes to the natural health product under assessment.
Changes to non-medicinal ingredients and brand name(s) are acceptable at any stage provided the changes do not affect the safety, efficacy and / or quality of the product. For example, any non-medicinal ingredients being added must be present in NHPD's Ingredients Database (NHPID).
Applicants are requested to clearly identify the relevant application by referencing the Submission Number in a cover letter so that the new information can be forwarded efficiently to the appropriate review team. Applicants can send this information by email to PLA.info.DLMM@hc-sc.gc.ca, by fax to (613) 954-2877 or directly to their Submission Coordinator via email.
12.2 Unacceptable application or formulation changes during review
Notwithstanding section 12.3 below, changes to the application which would result in a re-review by NHPD are not permitted; these changes include the addition of medicinal ingredients, addition of claims, changes to dosing, changes to route of administration and / or changes to dosage form. The initial assessment was performed based on the original formulation and therefore these changes are not accepted after the initial assessment stage.
12.3 Exceptions
At any time, applicants may remove proposed claims. Additionally, applicants are always encouraged to align their product with pre-cleared information published by NHPD. Pre-cleared information can be used to support the safety, efficacy and / or quality of product licence applications. Applicants can therefore revise proposed claims, ingredient quantities, dosing information or risk information to align with NHPD's pre-cleared information.
Applicants are also permitted and encouraged to update their application with a completed version of NHPD's Finished Product Specifications form at any time during the review. By completing and submitting this form, there is a reduced possibility of deficiencies relating to the quality of the product.
Please note that it is the intent of NHPD that the Finished Product Specifications form will be required in the future with regards to the performance targets outlined in this document.
Other revisions related to pre-cleared information may be acceptable but the applicant is advised to clarify with the Submission Coordinator before proceeding in order to ensure acceptability.
Applicants can send this information by email to PLA.info.DLMM@hc-sc.gc.ca, by fax to (613) 954-2877 or directly to their Submission Coordinator via email.
13. Re-Filed Applications
Applicants may re-file previously withdrawn applications or applications for which a Refusal Letter was issued. In all cases, a re-filed application is considered to be a new application and will be managed according to this policy. In addition, a re-filed application is subject to any new policies, procedures and / or guidance documents in effect at the time of re-filing.
13.1 Re-filing within six (6) months
If an application is re-filed within six (6) months of a Refusal Letter or Withdrawal Letter, the applicant may submit only the material requested in the outstanding IRN or listed in the Refusal Letter provided there is appropriate cross-referencing to the original material submitted. If the applicant chooses to cross-reference original material previously filed, certification that the original material pertaining to the natural health product remains unchanged must be included with the re-filed application. Applicants must also clearly identify new and previously submitted information in the cover letter or table of contents accompanying the re-filed application.
13.2 Re-filing after six (6) months
If an application is re-filed after six (6) months of a Refusal Letter or Withdrawal Letter, the applicant must submit a completely new application, i.e. no cross-referencing to previously submitted material is allowed. This procedure reflects the dynamic nature in the development of a natural health product.
13.3 Re-filing of a Rejected Application
If an application has been rejected as described in section 7.2, the applicant must submit a completely new application, i.e., no cross-referencing to previously submitted material is allowed.
14. Request for Reconsideration
The purpose of a request for reconsideration is to allow the NHPD and a PLA applicant to discuss issues related to a Directorate decision on an application. The parties may clarify and justify their positions using information available to the NHPD when the decision was made. The request for reconsideration must be based on the same information and material as the original decision. Information and material not submitted at the time of the initial decision will not be accepted.
The Reconsideration Process does not apply to the challenge of existing policies, guidelines or standards. The Directorate maintains other mechanisms to review and revise these documents which involve input from and consultation with a broad range of stakeholders. The Reconsideration Process also does not apply to issues related to changes in requirements resulting from the evolution of regulatory policy that have resulted in other products reaching the market under less stringent or more favourable conditions. Where requests for reconsideration involve these types of issues, the request will be denied.
For more information, please see NHPD's Reconsideration Process.
Proposed Performance Targets (In Calendar Days) For the Management of Product Licence Applications For Natural Health Products
Application type |
Administrative processing for application completeness |
Initial assessment |
Type of notice issued |
Full assessment |
Applicant response to full assessment (IRN) |
Assessment of applicant response |
Regulatory decision preparation |
|---|---|---|---|---|---|---|---|
| Compendial Application (Monograph) | 10 Days | 50 Days | Product Licence or Refusal Letter |
N/A | N/A |
N/A | N/A |
| Abbreviated Labelling Standard (AbLS) | 10 Days | 50 Days | N/A | N/A |
N/A | N/A | |
| Labelling Standard | 10 Days | 50 Days | N/A | N/A |
N/A | N/A | |
| Amendments (referencing pre-cleared information) | 10 Days | 50 Days | N/A | N/A |
N/A | N/A | |
| Non-Traditional (including TPD Cat IV / LS) | 10 Days | 20 Days | Application Acceptance Letter or Refusal Letter |
90 Days | 30 Days |
45 Days | 15 Days |
| Traditional | 10 Days | 20 Days | 90 Days | 30 Days |
45 Days | 15 Days | |
| Homeopathic Medicines | 10 Days | 20 Days | 90 Days | 30 Days |
45 Days | 15 Days | |
| Amendments for a Significant Change requiring assessment of Safety, Efficacy and / or Quality | 10 Days | 20 Days | 90 Days | 30 Days |
45 Days | 15 Days |
Please note: Day 1 of the 180 day period referred to in Section 2 (1) b of the 
E: Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) begins at this point for accepted applications.
