Natural Health Products Online System: Additional Information
The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.
Thank you for your patience and understanding.
On this page:
- Web Product Licence Application Form
- Natural Health Products Ingredient Database
- Natural Health Products Ingredient Database Issue Form
- Trading Partner Accounts
- Epost Connect
The Natural Health Products (NHP) Online System is a suite of secure web applications and tools that you can use to fill your NHP product licence application. It accurately captures data, reducing the need for Health Canada to send follow-up requests for missing information. Although it accommodates all classes and types of NHP applications, it includes a feature that validates the information provided in Class I Compendial applications against all monograph requirements.
For applicants, the NHP Online System includes:
- Trading Partner accounts
- the web-based Product Licence Application form
- the Natural Health Products Ingredient Database (NHPID)
- the amendment and notification form
Web Product Licence Application Form
The Web Product Licence Application (web PLA) form is a web-based application that replaces the Natural and Non-prescription Health Products Directorate’s (NNHPD) PDF (ePLA) and paper versions of the Product Licence Application Form. The web-based application has the following key improvements:
- connects with the NHPID to ensure that ingredients, terminology, and monograph data is accurately reflected in your application.
- ensures that applications are complete and accurate before being submitted.
- validates completed compendial class I applications against all monograph requirements before being submitted.
- These improvements reduce the need for Health Canada to request additional information from applicants.
Electronic submission of completed documents to NNHPD
The NNHPD will only accept applications submitted electronically. Applications submitted in hard-copy (e.g., on paper), will not be accepted. The NNHPD will not accept scanned copies of the web PLA form. Stakeholders are strongly encouraged to enroll as a Trading Partner and use Canada Post's epost Connect secure communication service, to ensure that the applicable service standard can be respected. For more information, please visit epost Connect of Canada Post.
The web PLA form does not transmit any data to the NNHPD. Applicants are required to save their finalized forms and submit them by email via epost Connect.
Saving an application form
We recommend saving your work after completing a page, after entering five ingredients, or after 30 minutes, whichever comes first. We also recommend saving template web PLA forms under different names after completing contact information. Finally, it is also preferable to save your form before finalizing it and obtaining a tracking number. This way, you are able to use this un-finalized version as a template for new product submissions that may be very similar and generate a unique tracking number each time you finalize the form.
Tracking numbers for web PLA forms
The tracking number is an internal number that the NNHPD uses to catalogue applications. Having duplicate tracking numbers for different products will cause delays with new applications and a refusal of your submission. Tracking number duplication can be avoided by ensuring that web PLA forms are saved with both a finalized and un-finalized versions of the application. The un-finalized version of the form can subsequently be used to modify and finalize a new application while creating a new tracking number.
Using a Mac with the NHP Online System
The NNHPD does not test products to confirm that they are functional on Macintosh environments. If you have a Mac, please use Firefox, Chrome and/or Safari for the best user experience when accessing the NHP Online System.
Natural Health Products Ingredient Database
- Natural Health Products Ingredients Database Web Application Guide
- Natural Health Products Ingredients Database Instructional Video
The NHPID is a database holding the validated and pre-cleared NHP ingredient information. It provides standardized information that includes:
- ingredient roles and functions
- controlled vocabulary such as test methods and units of measurement.
It also assists applicants in populating sections of the web PLA form based on the application and class type.
The information in the NHPID includes information reviewed by the NNHPD and is updated regularly to reflect advancements in scientific knowledge on NHPs. We encourage applicants to submit requests for modifications or additions to the NHPID using the Natural Health Product Information Database Issue Form.
Searching for information in the NHPID
Quotation marks and wildcard characters can be helpful in conducting specific searches in the NHPID as they can help target what you are looking for. The search tip section of the Natural Health Products Ingredients Database Web Application Guide details the usage of such marks and characters when searching in the database. For example, by performing an ingredient search with "Calcium" in double quotes (“..”), you will immediately retrieve the ingredient Calcium, as opposed to receiving over 100 results containing the text ”Calcium” in one of the ingredients’ names. It is also possible to narrow down your ingredient search further by selecting a specific role (e.g., Medicinal, Non-medicinal, Homeopathic, etc.) as an additional parameter, when applicable.
Finding particular constituents available for an ingredient
Constituents are indicated as sub-ingredients in the NHPID. For chemical substances, the display of sub-ingredients is straightforward. For example, “Calcium” will appear as a sub-ingredient for the “Calcium carbonate” entry.
For organism substances, the sub-ingredients are associated with organism parts. You can access these by clicking on the organism's name in the “Source Material(s)” section of the page. For example, you can perform a search on “Garlic” and then click on the “Allium sativum” organism substance entry. Beside the “Source Material(s)” heading, you can click on the organism name “Allium sativum”, which will take you to a new page with some additional organism information. This will include a list of organism parts that have constituents associated with them, under “Source Material Constituent(s)” if any are available. Clicking on the part will bring you to the constituent list. For example, clicking on “Bulb” part listed under “Allium sativum” will bring you the list of all constituents for that part.
Restrictions in the NHP Online System
Restrictions for ingredients are meant to inform applicants on limits that the NNHPD considers when reviewing products. These restrictions may pertain to dosage amounts, the role an ingredient can have in an NHP, or the allowable route of administration. For example, applicants can only select non-medicinal ingredients that are acceptable as non-medicinal ingredients as outlined in the NHPID. If there are restrictions that are not currently available in the NHP Online System such as non-medicinal ingredient purposes, the applicant will need to submit an NHPID Issue Form and send to the NNHPD for evaluation.
Herbal components in the web PLA form
Herbal components such as “aloins” and “total gingerols” which cannot be isolated for medicinal use (see the Standard Terminology guidance document), cannot have a medicinal role. They can only be present in the web PLA form as constituents of an organism's specific part (e.g., “Aloe vera” – Whole plant; “Zingiber officinale” - Rhizome).
Natural Health Products Ingredient Database Issue Form
- Natural Health Products Ingredients Database Issue Form Guide
- Natural Health Products Ingredients Database Issue Form Instructional Video
When making a request to add new ingredient information or modify existing ingredient information in the NHPID, scientific evidence supporting the request is required. The evidence provided must be from recognized, published scientific documentation and from an authoritative source; examples are provided at the bottom of the NHPID Issue Form. The evidence should be specific when supporting a request. For example, when asking to add “flavour enhancer” as an excipient purpose for an ingredient, the evidence must clearly demonstrate that the specific ingredient has been used to provide a flavour in other products. When submitting evidence, it is the applicant's responsibility to provide either a pdf of the supporting documents or an active web link to the information. The NNHPD will not be able to review such a request if the evidence is referenced but not provided.
Requirement to specify organism parts when requesting to add an organism
This obligation depends on the request. Since the web PLA form allows the user to build their own defined organism substance in the medicinal ingredient section, applicants do not need to specify organism parts when adding a medicinal role to an organism. When requesting a non-medicinal role for an organism however, the organism's part must be specified, as not all parts can be used for a specific non-medicinal purpose. For example, the roots of a plant may provide skin-conditioning properties, while its leaves may provide flavouring properties. Finally, when making a request to add a sub-ingredient to an organism, the part of the organism must also be specified. Sub-ingredients are very particular to parts of the organisms and not all parts may produce the sub-ingredient requested.
Trouble finding ingredients in the web PLA form
When an ingredient is in the NHPID, the most common reason why an applicant cannot find it in the web PLA form is because the ingredient has either an alternate spelling or differing nomenclature. For example, all flavours are spelled with “flavour” and not “flavor” in the NHPID.
Another reason you may have trouble finding an ingredient in the NHPID is if the ingredient is not registered for the ingredient role required for your product. For example, if an ingredient has a non-medicinal ingredient role only and you attempt to select it in the Medicinal section, you will not find it in your search.
Alternatively, the ingredient may not be in the NHPID. In cases where you would like to propose modifications to either a name or role of an ingredient or if you would like to add a new ingredient, you will need to submit an NHPID Issue Form and send to the NNHPD for evaluation.
Adding non-medicinal purposes in the web PLA form
The web PLA form uses non-medicinal ingredient purposes that exist in the NHPID specific to the ingredient chosen. For example, if an ingredient only has “Flavour Enhancer” listed as its non-medicinal ingredient purpose in the NHPID, then “Flavour Enhancer” will be the only selectable non-medicinal ingredient purpose in the web PLA form. Also, you will want to ensure that the ingredient you have selected in the web PLA form is identical (i.e., has the exact same name) to the ingredient in the NHPID. If the names do not match, then you have selected another ingredient which may not have the non-medicinal ingredient purpose you seek.
In cases where you would like to propose the addition of a new non-medicinal ingredient purpose to an ingredient or if you would like to add a new ingredient, you will need to submit an NHPID Issue Form and send to the NNHPD for evaluation.
Source Ingredient and Source Material list for certain ingredients in the web PLA form
Source materials are defined as a combination of organism and part from which an ingredient is sourced.
Source ingredients are defined as ingredients that can be used as a source, typically chemical substances.
The ingredient “Calcium”, for example, can be sourced from “Calcium carbonate”, which is a source ingredient, or it can be sourced from cow's milk (“Bos taurus – Milk”), which is a combination of organism and part. When an ingredient has both source ingredients and source materials, both lists will appear in the electronic form. To successfully complete the form, a selection must be made from at least one of those two lists.
Adding dosage forms in the web PLA form
Dosage forms are directly related to the route of administration you select in the web PLA form. The most common reason applicants do not find the desired dosage form in the web PLA form is because they have selected an incompatible route of administration.
It is important to note that some dosage forms do not appear in the web PLA form, as they are synonyms for existing dosage forms. To see if the dosage for you want to use has another term, use the NHPID’s controlled vocabulary search for dosage forms. For example, “Gummy” will not appear in the web PLA form, as it is a synonym for “Block”. Therefore, applicants should select “Block” when filling out their web PLA form. “Gummy” can still be used on the label.
Trading Partner Accounts
A Trading Partner is a company or private business that has gone through the steps of validating their status with the NNHPD. Companies or businesses that are recognized as Trading Partners can transact with the NNHPD electronically via epost Connect secure conversations. It allows a company to submit confidential documentation directly to the NNHPD via email and allows users to track their transactions.
A Trading Partner requires a Primary User (delegated in writing by the company) who is legally responsible for the company's account. The account remains active so long as the Primary User remains active with the company.
Enrolling as a Trade Partner
In order to enroll as a Trading Partner, you will need to fill out two (2) copies of the Trading Partner Agreement, one (1) copy of your Trading Partner Profile and provide a Proof of Company Name and Signing Authority by email to the NNHPD (scanned copies are acceptable).
You will also have to submit two copies of the Trading Partner Agreement by mail or courier to the NNHPD . For more information including the address for mailing, please go to the Trading Partner Enrolment Page.
Proof of company name is a legal documentation that states the company's official registered company name. It is a proof of identity that is required to legally recognize the Trading Partner in their agreement with the NNHPD. Some examples include a company registration document filed with the provincial government, business documentation prepared by a lawyer, or tax return documentation.
Duration of process
Trading Partner enrollees should expect to receive an acknowledgment of receipt of the electronic Trading Partner package within one (1) business week of receipt. If they have not heard back from the NNHPD after one week, they are welcome to write to the NNHPD to request an update.
Primary Users for Trading Partner Account
It is not possible for companies to have more than one Primary User for their Trading Partner account. However, the Primary User of the account can choose to give Delegated Users “Primary User Access”. This access allows a Delegated User to have the same permissions as a Primary User with the sole exception being that they will be unable to remove or modify the Primary User's information. A Delegated User with Primary User Access must come from the same company as the Primary User and must be added by the Primary User.
Using consultants as trading partners
A consultant can sign up to deal on behalf of an applicant company. The consultant must sign up by going through all the regular enrolment steps and enroll their own company (not the company of their client). In order to submit on behalf of another company once signed up, a Designated Party Authority form authorizing their signing authority on behalf of the company, if one is not already on file, and their name listed in the application as a Contact person is required. The company they represent will also need to have a trading partner account.
Using a Trade Partner account to submit a Product Submission Package
All electronic submission documentation should be sent via epost to the NNHPD initiated conversation for new applications.
Always keep your documents and web PLA form together (within a zip file for example) to ensure that it is clear to the NNHPD that these items reference the same product licence application.
If you send additional information related to your application subsequent to its submission, reference your submission number or web PLA form's tracking number.
Updating Trading Partner information
To update your Trading Partner information, the Primary User or Delegated User with Primary User Access must fill out a new Trading Partner Profile and submit it via the NNHPD initiated Trading Partner Conversation through epost Connect.
Sharing individual Epost Connect e-mail
Your epost Connect e-mail account acts as your personal signature. Sharing it with others compromises the validity of your signature. Each user must have an individual e-mail account associated to their epost Connect address and must use that account when corresponding with the NNHPD, via the epost Connect conversations.
Epost Connect is a secure cloud document delivery and collaboration service offered by Canada Post. The NNHPD currently uses epost Connect to correspond with companies (Trading Partners). Trading partners will receive notifications by email when they receive correspondence from us through their e-Post account, and they will retrieve it by logging into the secure site. Refer to the Natural Health Products Management of Applications Policy on submitting applications by secure email.
For more information, please visit epost Connect of Canada Post.
Registering with epost Connect
Go to epost Connect of Canada Post and click “Sign in to epost”. Follow the instructions on the screen to create the account. All you need is an email account to register. It will take less than five minutes to complete the process. It is free to register an epost account.
Benefits of registering with epost Connect
Having an epost Connect account allows applicants to securely send and receive application correspondence electronically with the NNHPD. Benefits include:
- no user fees
- easy to use system
- fully electronic system
- multiple designated contacts can view and respond to the same conversation
- security and confidentiality is maintained in the protected system
- saves history of applications and correspondence is in one location and readily viewed
Checking epost Connect
When you are sent a message on epost, you will receive a notification email informing you that a new message is waiting in the system.
When logged in, the system also indicates which conversations have new messages via a visual icon.
The difference between having an epost account and being a Trading Partner
Becoming a Trading Partner associates your signature with your email address. If you are a Trading Partner, you can submit new applications electronically (e.g., for: products, sites, clinical trials, master files) via a specific conversation in epost without signatures on the document.
If you are not a Trading Partner, you can still receive and reply to submission correspondence from the NNHPD electronically via epost Connect. New applications will not be permitted through this channel without a Trading Partner agreement, as per above. Refer to the Natural Health Products Management of Applications Policy on methods of submitting applications.
Become a Trading Partner at any time by referring to the Guidance Document on How to Interact with the Natural Health Products Directorate Electronically.
Sending NNHPD correspondence to epost Connect account
The NNHPD’s standard practice is to send all correspondence via the epost connect system.
We will use the email address of the application contact(s) on the web PLA form. Please ensure that this address is the same as the e-mail associated with your epost Connect account.
Sharing individual epost Connect email
Each user must have an individual e-mail account associated to their epost Connect address and must use that account when corresponding with the NNHPD, via the epost Connect conversations.
For questions concerning the NHP Online System, contact the NNHPD Online System Support.
For questions concerning the NHPID, contact NNHPD's Ingredient Support.
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