Guidance document on how to interact with the Natural Health Products Directorate electronically

September 28^th, 2012 - Version 3.0

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Table of contents

• 1. Introduction
  • 1.1 System Requirements
• 2. PosteCS™
  • 2.1 Security Settings
• 3. Trading Partner
  • 3.1 Roles
    • 3.1.1 Trading Partner (the Applicant Company)
    • 3.1.2 Primary User
    • 3.1.4 Delegated User
    • 3.1.5 Delegated User with Primary User Access
  • 3.2 Trading Partner Enrolment
    • 3.2.1 Trading Partner Agreement
    • 3.2.2 Trading Partner Profile form
    • 3.2.3 Proof of Legal Authority
    • 3.2.4 Submitting Enrolment Application & Process
  • 3.3 Maintaining Trading Partner Status
• 4. Submitting Electronic Applications
  • 4.1 Submitting through PosteCS
  • 4.2 Submitting on CD/DVD
  • 4.3 Submitting ePLA by paper
  • 4.4 Maintaining electronic format
    • 4.4.1 Responding to Information Request Notices & Clarimails
    • 4.4.2 Post-Licensing Changes on ePLA
• 5. Inquiries and Assistance

List of figures

• Figure 1 - Example of a PosteCS message
• Figure 2 - Screenshot of security settings in PosteCS
• Figure 3 - Flowchart of the Trading Partner Enrolment Process
• Figure 4 - Screenshot of part of the Finalized Trading Partner Profile form
• Figure 5 - Screenshot of form to Modify an existing Trading Partner

1. Introduction

This document is intended to provide a summary of information on how to interact electronically with the Natural Health Products Directorate (NHPD) of Health Canada. A key objective of the Natural Health Products Online Solution (NHPOLS) is to provide an end-to-end process for the electronic exchange of protected information between NHPD and applicants.

By taking advantage of the electronic tools available through the Natural Health Products Online Solution, applicants will experience an efficient, secure, and cost-effective way of submitting applications and dealing with NHPD electronically. The benefits are:

• Quick and cost-effective means of communication
• Reduced frequency of application errors
• Receipt confirmations and tracking
• All correspondence sent in electronic .pdf format, resulting in less paper

1.1 System Requirements

To use the electronic forms associated with the Natural Health Products Online System most effectively, be sure that your workstation meets the System Requirements, as found in the Features and System Requirements page.

2. PosteCS™

PosteCS is a secure email service provided by Canada Post, which has the ability to send content-sensitive documentation quickly and efficiently while receiving real-time confirmation of successful receipt. PosteCS is a cost-effective service, and allows up to 100 mb of information to be sent in one package, allowing for multiple applications to be submitted at once.

To sign up for a PosteCS account, please contact the NHPD. For more information on the PosteCS service, please visit the PostCS Secure email enrollment page.

Using the PosteCS secure email system is similar to using other Web-based electronic mail software (such as Microsoft Outlook, Hotmail, Yahoo Mail etc.). Using an active Web browser, a user is able to log on to Canada Post's PosteCS site with a valid Identification (ID) and password.

When a new package is received, the recipient will receive the following notice in their Inbox.

To retrieve a package, the user must connect to the PosteCS account by selecting the Web address provided in the notification, or by going to the PosteCS Web site and logging in.

Applicants can learn more about this service with Canada Post through its  PosteCS FAQ.

If experiencing technical difficulty when signing up for a PosteCS account, or if there are any issues with an existing account (e.g. messages not sending, password issues), please contact Canada Post to resolve the issues.

2.1 Security Settings

For the security features to work properly, the user must configure their PosteCS account User Preferences. Specifically, for 'New Package Preferences', the Security selection must be 'Account Password Protection'. This setting ensures that messages sent by the Trading Partner can only be received by another PosteCS account such as the ones used by the NHPD.

Please note that NHPD will only accept emails from a registered Trading Partner with a valid PosteCS email address.

3. Trading Partner

A user must enrol and become a registered Trading Partner in order to communicate with NHPD electronically through PosteCS.

The NHPD deals electronically with 3 types of Trading Partner:

1. The applicant company
2. A third-party consultant, submitting on behalf of the applicant company
3. Both applicant company and third-party consultant

3.1 Roles

Before beginning the Trading Partner enrolment process, it is recommended that a company defines users for the following roles.

3.1.1 Trading Partner (the Applicant Company)

• An entity that has the status of a person in law (proof required)
• May be a person or an entity created by law to conduct commercial business
• A corporation, division, law firm, a consultant firm or another business or company who has a legally registered business name
• Self-employed or natural person who has a registered business such as a consultant, naturopath, shop owner, etc
• A partnership between two companies who have legally registered business names and a partnership agreement that recognized their partnership
• Has only one Primary User
• May have one or more Delegated Users

3.1.2 Primary User

• A person who signs the Trading Partner agreement on behalf of the Trading Partner (applicant company) (requires proof of authority to sign, refer to Section 3.2.3)
• Is held legally accountable by the NHPD for all electronic activity submitted by all users on behalf of the Trading Partner
• Can delegate or revoke authority to others (Delegated Users) to transact electronically with the NHPD on behalf of the Trading Partner, but is still held accountable for this activity
• Is responsible for keeping all the Trading Partner information up to date (i.e. Delegated Users, contact information, Company Name etc.)

3.1.4 Delegated User

• A person who has been designated by the Primary User to transact electronically with the NHPD on behalf of the Trading Partner (e.g. send documents)
• There can be any number of Delegated Users for a Trading Partner
• Delegation remains in effect until revoked by the Primary User
• Can submit changes to their own information (e.g. update to email address, phone number)
• Can be from the Primary User's company or a 3^rd Party Consultant, in which case the 3rd party company must also enrol as a Trading Partner

3.1.5 Delegated User with Primary User Access

• A Delegated User with Primary User Access does not have the authority to change the relationship between the Primary User and the Trading Partner;
• May perform the functions of the Primary User if delegated by Primary User.
• May delegate or revoke authority to others (Delegated Users) to transact electronically with the NHPD on behalf of the Trading Partner.
• When applicable, is responsible for keeping all the Trading Partner information up to date (i.e. Delegated Users, contact information, Company Name etc.).
• Delegated User with Primary User Access must be from the Primary User's company.

Each user indicated above must have an active PosteCS email address to uniquely identify them. The NHPD Trading Partner enrolment process establishes the PosteCS address of each individual as the electronic equivalent of a personal signature; therefore each address must be exclusive to the individual. The Trading Partner can sign up for one PosteCS account (address) with Canada Post and then create a unique sub-account for each user. Please refer to the PosteCS website for more information and how to create sub-accounts.

3.2 Trading Partner Enrolment

The enrolment process begins by downloading the necessary forms from the NHPD website.

A completed enrolment package will include the following information:

• 2 completed and signed copies of the Trading Partner Agreement (Section 3.2.1)
• 1 completed and signed copy of the Trading Partner Profile form (Section 3.2.2)
• 1 Proof of Signing Authority (Section 3.2.3)
• 1 Proof of legal name (Section 3.2.3)

3.2.1 Trading Partner Agreement

The Trading Partner Agreement sets out the terms and conditions available to the Trading Partner for the purpose of communicating electronically with the NHPD.

A company doing business under a different name from the true name of the owner must indicate both its legal (registered) name and its trade name on the Trading Partner Agreement. If a partnership exists, it should also set out the names of the partners.

3.2.2 Trading Partner Profile form

The Trading Partner Profile identifies all Trading Partner information such as users, roles, contact information and shared secrets. The NHPD uses this form to initialize and update Trading Partner accounts.

The Trading Partner Profile form is completed using Adobe Reader software (refer to Section 1.1 System Requirements). The Trading Partner Profile form is downloaded from the NHPD website and completed on the user's workstation.

The form can be completed in both English and French by selecting the appropriate button at the top of the form. To enrol as a new Trading Partner, select the option for 'New Trading Partner Profile'. All required fields are marked by an '*'; the form cannot be finalized or submitted until all required fields are completed.

Part 1 of the form is used to identify the Trading Partner in Section A and Primary User in Section B. Section C defines the Shared Secrets; these four questions are used to authenticate the identity of the Primary User during the enrolment process. The answers to these pre-determined questions should be brief, unique to the individual and easy to remember.

Part 2 of the form is for the Primary User to identify any Delegated Users who will be authorized to transact on behalf of the Trading Partner. To add more than one Delegated User, select the 'Add a Delegated User' button. A delegated user does not need to be identified during enrolment, and can be added at a later date. For more information, refer to Section 3 - Maintaining Trading Partner Status.

A Delegated User can be assigned designated authority privileges that would allow them to act as the Primary User to add and remove other Delegated Users on the Trading Partner Profile, as well as modify the contact information of the Trading Partner. The Trading Partner Profile form currently does not allow for this to be indicated and thus the Primary User must submit a letter along with the Trading Partner Profile form indicating which, if any, Delegated Users would have such authority.

Once completed, the form must be finalized by pressing the 'Finalize' button. The form will not finalize until all mandatory fields have been completed. Upon finalization, a green box will appear at the top and bottom of the form with the message 'This form has been completed'. Only forms that display this message will be accepted by NHPD.

Once finalized, the Attestation section must be signed by the Primary User before submitting to NHPD.

It is strongly recommended to save and store your completed Trading Partner Profile form. Should you wish to modify it in the future (contact changes, trading partner info changes), you will be able to work directly off of this form by selecting 'Modify' instead of starting a new application. See Section 3.3 for more information on making changes to an existing Trading Partner profile.

3.2.3 Proof of Legal Authority

As part of the Trading Partner application, proof of the Primary User's legal capacity to sign the Trading Partner Agreement on behalf of the Trading Partner must be provided. There are two types of supporting documents required:

1. Proof of the legal name of the Trading Partner; and
2. Authorization that the named Primary User has the legal authority to sign on behalf of the Trading Partner.

The supporting documentation will depend on the individual Trading Partner circumstances. For example:

1. Proof of the legal name of the Trading Partner:
   • For a corporation, any one of:
     • Certificate of Incorporation (showing incorporated name, business address and officers/senior official) provided by the Ministry of Consumer and Commercial Relations; or
     • Letters patent or any other official incorporation document.
   • For a natural person who has a registered business name, any one of:
     • Business Registration; or
     • Goods and Services Tax notice from the Canada Revenue Agency.
   • For a partnership:
     • The partnership agreement (showing partnership name, business address and names of partners).
2. Authorization that the named Primary User has the legal authority to sign on behalf of the Trading Partner
   All Trading Partner enrollees will need a letter stating that the named Primary User has the legal authority to sign on behalf of the Trading Partner; letter must be written on corporation letterhead signed by a senior official within a company. Proof of a senior official's authority to designate a primary user may be required if their name is not stated in the documentation used for Proof of legal name.
   NOTE: Not sure what supporting documents to provide? Contact the Natural Health Products Directorate by email.

This sample Signing Authority Template can be used as an example to give legal authority to a primary user to sign on the behalf of the trading partner.

3.2.4 Submitting Enrolment Application & Process

Submitting enrolment application:

The completed enrolment package must include:

Two Trading Partner Agreements need to be completed in full and sent to the NHPD so that the NHPD can keep one on record and provide one to the applicant for record purposes.

Enrolment requests cannot be processed without appropriate and complete supporting documentation.

The enrolment package must be submitted to the NHPD by regular mail or courier (fax and regular email submission will not be accepted) as the enrolment application requires that signed originals be provided.

Packages must be delivered to:

• Health Canada
  Natural Health Products Directorate
  NHP Online Trading Partner Enrolment
  2936 Baseline Road, Qualicum Tower A
  Ottawa, Ontario K1A 0K9
  Canada

The Primary or Delegated User may check the status of the enrolment request by contacting the Natural Health Products Directorate by email.

Enrolment Application Process at NHPD

Review of the enrolment application begins once the complete package is received at NHPD. The Primary User may be contacted if the NHPD has any questions or requires any clarifications about the enrolment package contents. The NHPD will schedule a telephone interview by contacting the Primary User at the PosteCS email address that was indicated on the Trading Partner Profile form. The telephone interview with the Primary User is to confirm the contents of the Trading Partner Profile that was included as part of the enrolment submission, i.e. the answers to the shared secrets, and takes minimal time (approximately 5 minutes). The NHPD will then approve the enrolment based on the results of the interview and contents of the application.

Confirmation of Enrolment

When the enrolment application is approved, NHPD will activate the Trading Partner Natural Health Products Online System account and set up the Primary User and any Delegated Users for the Trading Partner.

Upon successful enrolment, the Trading Partner receives the following:

• A confirmation message sent to the Primary User by PosteCS secure email;
• A signed copy of the Trading Partner Agreement sent by regular mail.

Upon confirmation of enrolment, the Trading Partner can now begin to correspond with NHPD electronically using PosteCS email. Once successfully enrolled, all correspondence from NHPD will be sent to the company by PosteCS.

3.3 Maintaining Trading Partner Status

It is important to keep the Trading Partner Profile up to date as correspondence can be sent at any time from NHPD. The Trading Partner Profile form is used to maintain trading partner information, such as:

• Trading Partner company information (name, address etc.);
• Contact information for Primary or Delegated Users;
• Adding or Revoking Delegated users;
• Shared Secrets

To make changes to an existing Trading Partner, select the 'Modify Existing Trading Partner Profile' at the top of the Trading Partner Profile Form.

Each section of the Trading Partner Profile form has a modify button, which can be selected to indicate that changes are being made. For Delegated Users, there are three options:

1. Add - to be used when adding new delegated users
2. Modify - to be used when revising information for existing delegated users
3. Revoke - to be used when a delegated user is no longer active

Revised Trading Partner forms must be finalized to ensure that all mandatory fields are complete before sending to NHPD. Modified forms do not require a signature and NHPD will accept modified forms by email trough PosteCS.

All modified Trading Partner Profile forms can be sent to the following email address: NHPSN_POSTECS_TPC@hc-sc.gc.ca

4. Submitting Electronic Applications

The Natural Health Products Online Solution's suite of tools provides a completely electronic process for product licence applications. Using the electronic Product Licence Application form (ePLA) allows the applicant to take advantage of the many benefits offered. When combined with the electronic Submission Builder (eSB), the applicant benefits from the enforced requirements. Using these tools together helps to minimize the chance of refusals and deficiency requests/follow-up, as well as the time taken for processing the applications.

Some general requirements when using the electronic tools:

• ePLA must be finalized; unfinalized ePLAs will be returned to the applicant
• the eSB package (.hcs format) must be validated; unvalidated packages will be returned to the applicant

For more information on the ePLA, please refer to the Natural Health Products Online Solution electronic Product licence application guide.

For more information on the eSB, please refer to the NHP Online eSubmission Builder.

4.1 Submitting through PosteCS

The most efficient way to submit an ePLA is using PosteCS email.

• NHPD only accepts packages from enrolled Trading Partners through PosteCS
• NHPD accepts all new applications through PosteCS
• NHPD will accept correspondence, e.g. IRN and clarimail responses, requests for reconsideration etc., through PosteCS
• Keeps the application process electronic and paperless, saving on paper and storage costs
• Allows for more efficient processing (e.g. internal data entry) and sending of correspondence
• If a new application is submitted by PosteCS from a delegated user, the delegated user must have a DPA (Designated Party Authorization form) from the product licence holder. This is because the PosteCS account acts as the electronic signature for the ePLA (as verified through the Trading Partner enrolment process).
• Does not require a hard copy to be sent by regular mail.

4.2 Submitting on CD/DVD

Less efficient than PosteCS, however it still allows NHPD to maintain the electronic records and if using ePLA allows application to proceed through a paperless process.

• When submitting an ePLA by CD/DVD, the Senior official or delegated contact, with a DPA, must sign and print the attestation code on the top of the CD/DVD
• Must ensure that all documents are working and not password protected. Password protected or damaged files will not be processed and must be re-sent to NHPD

4.3 Submitting ePLA by paper

Applicants can still benefit from the ePLA by printing the ePLA and mailing it in. When printed, the senior official or designated contact, with a DPA, must sign the finalized ePLA form. Please note that all ePLAs, whether submitted electronically or by paper, must be finalized; only upon finalizing will the signature block appear when printed.

4.4 Maintaining electronic format

When sending in a revised ePLA, the applicant must send the complete ePLA, not just the relevant pages; this ensures that NHPD has the most up to date information, and helps ease update in to our online systems.

Responses can be sent through PosteCS with a new, updated version of ePLA at any time. Otherwise, respond in the way the initial application was submitted.

4.4.1 Responding to Information Request Notices & Clarimails

When responding to IRNs and Clarimails, respond with the full revised ePLA. If initially submitted by CD, send in response by CD to maintain electronic status. If information is faxed or mailed in, the electronic status is compromised and there will be no benefit from the electronic tools or a paperless process. Additionally, during the response process, a complete ePLA may be submitted to replace a paper application form. If submitting a revised ePLA, please ensure that only what was requested is changed and the rest of the ePLA matches the previous paper version.

4.4.2 Post-Licensing Changes on ePLA

Any post-licence change, e.g. amendments and notifications, can be submitted using the ePLA. If the original application was submitted on paper, please ensure that the ePLA matches the originally submitted paper PLA. NHPD requires a complete, finalised ePLA to be submitted for a post-licence change.

5. Inquiries and Assistance

Inquiries related to Trading Partner Management should be submitted using the PosteCS account and sent to the following secure email: NHPSN_POSTECS_TPC@hc-sc.gc.ca

• Address to be used exclusively with PosteCS (non-PosteCS messages will be returned)
• Requests for Trading Partner enrolment
• Request for modifications to an existing Trading Partner Profile

Inquiries related to Submissions Management should be submitted using the PosteCS account and sent to the following secure email: NHPSN_POSTECS_SM-GP@hc-sc.gc.ca

• Address to be used exclusively with PosteCS (non-PosteCS messages will be returned)
• To submit new applications
• Correspondence relating to product or site licence applications, master files etc.

Inquiries related to the Natural Health Product Ingredients Database Support should be sent to the NHPD by email.

• Request additions or modifications of Ingredient Information to the NHPD via Issue Form
• Request additions or modifications of Controlled Vocabulary in the NHPD via Issue Form

Inquiries related to the Natural Health Products Online Solutions should be sent to the NHPD by email.

• Inquiries regarding Trading Partner Enrolment
• To report feedback or technical issues with the NHPD's electronic tools and forms

Inquiries related to Natural Health Product Licensing should be sent to the NHPD Product Licensing email account.

• Request for contact information for Submission Coordinator
• Pre-submission meeting requests
• Product Licence correction requests and PLA withdrawal requests
• Company information updates
• To determine if your product meets the definition of a NHP
• Other inquiries regarding product licensing

Inquiries related to Natural Health Products Site Licensing should be sent to the NHPD Site Licensing email account.

• Contact information for Submission Coordinator (if unknown)
• Site Licence correction request
• General inquiries regarding site licensing, Good Manufacturing Practices and International Trade Certificates and Foreign Site Reference Number Application Process