Natural Health Products Online Solution: Frequently Asked Questions

 

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.

For questions concerning the Online Solution contact NHPD's Online Solution Support.

For questions concerning the NHPD's ingredient database contact NHPD's Ingredient Support.

NHP Online Solution - General Information

What is the NHP Online Solution?

The NHP Online Solution is a suite of secure electronic tools that allow for quicker drafting and processing of natural health product licence applications. Through accurate data capture and product content validation for the applicant the Online Solution provides higher quality submissions requiring fewer clarifications and contributes to faster decision making.

The suite of tools includes the Electronic Product Licence Application Forms (ePLAs), the Natural Health Products Ingredient Database (NHPID), the Electronic Submission Builder (eSB) and Trading Partner accounts.

What is the Natural Health Products Ingredient Database (NHPID)?

The NHPID is a database holding the NHPD's standards for validated NHP ingredient information and pre-cleared NHP information. Standardized information includes terminologies, ingredient roles and functions, and controlled vocabulary such as test methods and units of measurement. It also assists in populating selected portions of the ePLA based on the application type. The information found inside the NHPID, and thereafter populating the ePLA, is seen as the most current information from the NHPD. It is important to note that the information within the NHPID is constantly growing and evolving along with advancements in the knowledge of natural health products. As such, it only houses information that has been reviewed and does not represent the final state of all NHP related items. This is why the NHPD encourages applicants to submit NHPID Issue forms to modify and add new information to the database when required.

What is the Electronic Product Licence Application (ePLA) form and why should I use it?

The ePLA is an electronic version of the NHPD's paper Product Licence Application Form with several key improvements. To ensure that submitted applications are not missing information needed for processing, the ePLA will check that required fields were not left blank and that certain pieces of data are in the correct format. The ePLA also connects with the NHPID in order to confirm that only ingredients and nomenclature that have been pre-validated are selectable from the application. Certain data like NMI purposes are also pulled from the NHPID for specified ingredients. This ensures applications will contain less errors and be processed faster by the NHPD. Finally, the ePLA eliminates the need for paper, which expedites processing times and reduces costs. The NHPD is moving towards a paperless process; applicants should begin to familiarize themselves with the ePLA and start using them for their current and future applications.

How do I submit my completed documents electronically to NHPD?

Because an electronic submission package (HCS file) from the Electronic Submission Builder and an electronic form built using the electronic Product Licence Application (ePLA) contains confidential information about a stakeholder's business, they cannot be sent via regular email. Stakeholders should enrol as a Trading Partner and use Canada Post's epost Connect secure communication service. For more information, please visit the  epost connect website of Canada Post.

Does the Electronic Product Licence Application form auto-submit my application when I finalize it?

The ePLA does not transmit any data to the NHPD. Applicants are required to save their finalized forms and submit them by email via epost Connect.

What is a Trading Partner and why should I become one?

A Trading Partner is a company or private business that has gone through the steps of validating their status with the NHPD. Company or businesses that are recognized by the NHPD as Trading Partners can transact with the NHPD electronically via epost Connect secure conversations through their designated staff. It allows a company and its designates to submit confidential documentation directly to the NHPD via email removing the need for paper and giving users the ability 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 and that account remains active so long as the Primary User remains active with the company.

What is epost Connect?

Epost Connect is a super-secure cloud document delivery and collaboration service offered by Canada Post. Trading Partners will receive correspondence information and documents from NHPD, through Canada Post's epost™ service. Trading partners will receive notifications by email when they receive submission-related correspondence, and they will retrieve it by logging into the secure site. Due to the security standards set by Canada Post, this electronic delivery system is the only way NHPD will accept sensitive documentation electronically. For more information, please visit  Canada Post's epost Connect website.

What is the Electronic Submission Builder and why should I use it?

The eSB is a program that helps applicants applying for a product licence to gather all supporting documentation electronically into a single file. The program is dynamic depending on the type of product you are attempting to licence and has a set of checks that validate whether or not all the required documentation is present. This allows for faster processing times of the submission by the NHPD. The program is only compatible with a finalized version of the most recent ePLA. When saved, the program saves all documents including the ePLA into a single HCS file that can be submitted to the NHPD via epost Connect.

What are the system requirements?

Most modern PCs running Windows XP or higher will work with the NHP Online Solution tools. For best results, you will want to run Microsoft Internet Explorer when using the NHPID and will want to ensure that you have the most recent version of both Adobe Reader and Java. A complete listing of requirements can be found at the Features and System Requirements page.

I have a Mac, can I use the NHP Online Solution?

The NHPD does not actively test their products to confirm if they are fully functional on Macintosh environments. That said, browsers such as Firefox and Safari shouldn't encounter too many issues when accessing Online Solution tools and the ePLA should work with the Mac version of Adobe reader. Unfortunately, the eSB requires a Windows environment to install and run, so it will not work on a Mac environment at this time.

NHP Online Solution - Natural Health Products Ingredient Database

What's the best way to search information in the NHPID?

Quotation marks and wildcard characters are usually the best tools to use in searching the NHPID as they can help target your search. The search tip section of the NHPID Web Application guidance document details their usage in searching the database. For example, by performing an ingredient search with "Calcium" in double quotes, you will immediately retrieve ingredient Calcium as opposed to having over 100 results containing the text 'Calcium' in one of their names. It's 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.

My search found results, but none of them are the ingredient that I was looking for. Why?

When you receive search results, it means that the NHPID has found a match for the name you have entered. The reason why you can't see the name you were looking for in the search results most likely has to do with the fact that the name you were looking for is considered a synonym by the NHPD and not a proper or common name. This will only occur with organism entries. Synonyms do not appear on the search results page. In order to view synonyms for organisms, you will have to click on an ingredient in the search results and select the organism's name in the ingredient's "Source Material(s)" section.

How do I find out if a particular constituent is 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 and this is accessed by clicking on the organism's name in the 'Source Material(s)' section of the page. For example, one can perform a search on 'Garlic' and then click on the 'Allium sativum' organism substance entry. Besides 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 to them, under 'Source Material Constituent(s)' if there are any 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.

What do the restrictions in the NHPID mean?

Restrictions for ingredients are meant to inform applicants on limits the NHPD considers when reviewing product. These restrictions may be in the form of dosage amounts, a restriction of the role an ingredient can have in a Natural Health Product or a restriction on the allowable route of administration. For some restrictions such as NMI purposes and routes of administration, modifications must first be made to the NHPID prior to submission. The applicant will need to submit an NHPID Issue Form and send to the NHPD for evaluation.

Why am I unable to select a Herbal component as a medicinal ingredient in the ePLA?

Herbal components, being chemical substances 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 ePLA as constituents of an organism ingredient's specific part.

NHP Online Solution - Ingredient Database Issue Form

What kind of references do I need to provide?

When making a request to add new ingredient information or make modifications to existing ingredient information in the NHPID, scientific evidence supporting the request is required. The best form of evidence is recognized, published scientific documentation from an authoritative source. There are many examples of this type of evidence included at the bottom of the NHPID issue form. It is also important to note that 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 outline this specific ingredient has been used to provide flavour in 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 NHPD will not be able to proceed with a review of the request if the evidence is simply referenced without providing it.

Do I need to specify organism parts when making a request to add an organism?

This depends on the request. Since the ePLA 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. This is mainly due to the fact that when dealing with organisms, 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.

Do I need to be connected to the internet when filling out the request form?

When filling out the form, an internet connection is not required. However, once the form is complete, the applicant will need to connect to the internet to finalize the form. This allows the form to gather a unique tracking number required for internal purposes.

NHP Online Solution - Electronic Product Licence Application Form

Do I need to be connected to the internet when using the ePLA?

Yes, you must always be connected to the internet when using your ePLA. The ePLA maintains a constant connection with the NHPID in order to ensure that the data it is pulling and finalizing is the most up to date information. The ePLA will automatically lock itself, preventing any further progress until it is reconnected to the internet.

My ePLA is locked. What can I do?

The ePLA uses a protocol on your computer in order to access the NHPID. In order for this protocol to work correctly, your Adobe enhanced security settings must be disabled, the NHPID must be up and running and you must be connected to the internet. If these requirements are not met, the form will lock itself as a result.

Always double check your internet connection when using the ePLA.

To disable the enhanced security option, go into your Adobe reader preferences, find Security (Enhanced) and uncheck Enable Enhanced Security. Please note that you are only setting this security setting for the adobe program and not for your entire PC.

When the NHPID is undergoing maintenance, applicants can confirm if the database is active by logging into the NHPID and seeing if the webpage loads. If it does not, applicants will have to wait until maintenance is complete before the ePLA will unlock.

I am not receiving any error messages, but I can't use the form's lists and buttons. Why?

The ePLA uses Javascript in order to provide you with the lists you need when completing information in your application and provide validation for the data in your application. Therefore, the form requires that you have your Javascript enabled in Adobe reader. While the form will not lock, it will also not allow you to make any selections until Javascript is activated. To enable Javascript, go into your Adobe reader preferences, find Javascript and check Enable Javascript.

Why is my form behaving oddly or incorrectly?

Many times, any issues you may be experiencing with the ePLA will most likely be caused by a build-up of cache memory in the Adobe program you're using. We recommend you save the work you're doing and close out of the program. When you restart the Adobe program it should automatically clear out the cache memory and your form should begin working properly again. Should you continue to experience issues, please contact the NHPD to investigate the problem.

When should I be saving my form?

Applicants should be saving their work on a regular basis when using the ePLA. We recommend saving after completing a page, after entering 5 ingredients, or after 30 minutes, whichever comes first. We also recommend saving template ePLA under different names after completing Parts 1-3, but before starting Part 4. Finally, it's also a good idea to save your form right before finalizing the form and issuing a tracking number. This way, you are able to use this unfinalized version as a template for new product submissions that may be very similar to the previous product and generate a unique tracking number each time you finalize the form.

Can my ePLAs have the same tracking number?

No, the tracking number is an internal number that the NHPD uses to catalogue applications. Having duplicate tracking numbers for different products will cause delays with new applications. Tracking number duplication can be avoided by ensuring that ePLAs are saved with both a finalized and unfinalized version of the application. The unfinalized version of the form can later be used to modify and finalize a new application while creating a new tracking number.

My ingredient is not in the ePLA. What do I do?

When an ingredient is in the database, the most common reason why an applicant can't find it in the ePLA 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 could be that the ingredient may not have the role required for your product. If an ingredient has an NMI role only and you attempt to select it in the Medicinal section, you will not find it in your search.

Some ingredients that are organisms that have a part and method of preparation defined (see defined organism substances) will not be selectable in the ePLA as an ingredient because they can be built by the applicant in the ePLA. The applicant would select an organism ingredient, then select its organism part and method of preparation to create an ingredient such as garlic bulb dry (organism garlic, part bulb, method of prep dry).

Alternatively, the ingredient may not be in the NHPID at all. In cases where you need to make 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 NHPD for evaluation.

My non-medicinal purpose is not selectable in the ePLA. What do I do?

The ePLA uses NMI purposes that exist in the NHPID specific to the ingredient chosen. For example, if an ingredient only has Flavour Enhancer listed as its NMI purpose in the NHPID, then Flavour Enhancer will be the only selectable NMI purpose in the ePLA. Also you will want to ensure that the ingredient you have selected in the ePLA has the exact same name as the ingredient in the NHPID. If the names do not match, then you have selected another ingredient will may not have the NMI purpose you seek.

In cases where you need to make modifications to add a new NMI 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 NHPD for evaluation.

Why are there both a Source Ingredient and a Source Material list for certain ingredients of the ePLA?

Source materials are defined as a combination of organism and part from which an ingredient is sourced, while Source ingredients are 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. If the source ingredient or source material you need is not selectable, please complete an NHPID issue form and send to the NHPD for evaluation.

My dosage form is not selectable in the ePLA. What do I do?

Dosage forms are directly related to the route of administration you select in the ePLA. The most common reason people do not see their dosage form is due to the fact that they have selected an incompatible route of administration. It is also important to note that some dosage forms names do not appear in the ePLA due to the fact that they are synonyms for existing dosage forms. This is viewable in the NHPID's controlled vocabulary search for dosage forms. For example Gummy will not appear in the ePLA as it is a synonym for Block. Therefore, applicants should select Block when filling out their ePLA. Gummy can still be used on the label. In the case where you need to add a new dosage form to a route of administration, you will need to submit an NHPID Issue Form and send to the NHPD for evaluation.

Why am I unable to select a range for my extract ratio?

The ePLA is not currently built to include extract ratios that vary between an upper limit and lower limit. Should your product contain an ingredient with an extract ratio that should be represented as a range, you will have to select the average and include the range itself in a cover letter for your application. The NHPD is exploring the incorporation of this item into future ePLAs.

How do I get the Label Text Editor of the ePLA to use the units I wish to put on my product's package?

While the Weight/Measure/Number field of the Label Text Editor will contain a certain number of units based on the dosage form of your product, the list can never be all inclusive. For this reason, we have added a modifiable entry entitled '--Text Entry' which can be used to provide additional units. For example, litres is not available in the Weight/Measure/Number field for a mouthwash dosage form, but by overwriting '--Text Entry' with 'litres', one can easily indicate the amount in the container as, perhaps, 1.5 litres.

NHP Online Solution - Electronic Submission Builder

Why won't the eSB accept my ePLA?

The eSB is designed to only accept finalized forms and will not accept incomplete forms that have not been finalized. If you are having other issues with the eSB where it will not accept your finalized form, we urge you to contact the NHPD so we can investigate the cause.

How do I replace my old ePLA in the eSB with an updated one?

If you have made changes to your ePLA and don't want to rebuild your submission in the eSB from scratch, then you have the option of replacing the existing ePLA. You will have to open up eSB and reopen your completed HCS file. Once open you can select the "Import an Electronic Form" option from the File menu. This will allow you to select another finalized ePLA and replace the one that is currently packed in your HCS file. You will want to be cautious when replacing ePLAs as there is no way to undo this action and there is no way to retrieve an ePLA that has been replaced.

Why won't the eSB validate my submission package?

The eSB has built in validation rules where it will check that the minimum documentation requirement for each specific application types is met. For example, submitting a non-compendial application will require you to submit a finished product specification document. If documentation has not been attached to the submission when needed, then the eSB will display a red flag and request that you include the document before validating the submission. It will also display red flags in cases where you had told it that you would attach additional documentation, but have not yet done so (e.g. a cover letter). The eSB must validate the HCS file prior to it being submitted to the NHPD.

NHP Online Solution - Trading Partner Accounts

How do I enrol as a Trading Partner?

In order to enrol as a Trading Partner, you will need to fill out 2 copies of the Trading Partner Agreement, 1 copy of your Trading Partner Profile and provide a Proof of Company Name and Signing Authority. When these documents have been assembled, you will have to submit them by courier to the NHPD. For more information including the address for mailing, please go to the Trading Partner Enrolment Page.

What is a proof of company name?

It 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 Trading Partner in their agreement with the NHPD. Some examples include a company registration document filed with the provincial government, business documentation prepared by a lawyer or tax return documentation.

How long does the process take?

TP enrolees should allow 2 weeks for mail and one week for initial processing. If they haven't heard anything after 3 weeks, they are welcome to write to the NHPD to request an update.

Can I have more than one Primary User?

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 for 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.

Can a consultant be a Trading Partner dealing on behalf of an applicant company?

Yes, 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 enrol their own company (not the company of their client). In order to submit on behalf of another company once signed up, they would only require a Designated Party Authority form authorizing their signing authority on behalf of the company (if one isn't already on file) and their name listed in the application as a Contact person. The company they represent will also need to have a trading partner account.

How do I use my Trading Partner account to submit a Product Submission Package?

All electronic submission documentation should be sent via post to the NHPD initiated conversation for New applications.

We suggest using the Electronic Submission Builder to bundle your submission into one file. If you are unable to use the Electronic Submission Builder, you should always keep your documents and ePLA together (within a zip file for example) to ensure that it is clear to the NHPD that these items reference the same product licence application.

Other documentation that may be sent later on in reference to a submission in NHPD's queue should reference your submission number or ePLA's tracking number if a submission number has not yet been acquired.

How do I update my Trading Partner information?

To update your Trading Partner information, the Primary User or Delegated User with Primary User Access will have to fill out a new Trading Partner Profile with all the up to date and current information and submit it via the NHPD initiated Trading Partner Conversation through epost Connect.

Can I share my epost Connect e-mail with other users?

No. 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 NHPD, via the epost Connect conversations.

NHP Online Solution - epost Connect

How do I register with epost Connect?

Go to https://www.epost.ca  and click “Create Account”.  Follow the instructions on the screen to create the account.  All you need is an email account to register.  It will take less than 5 minutes to complete the process. It is free to register an epost account.

What is the benefit of registering with epost Connect?

Having an epost Connect account allows applicants to receive application correspondence electronically from NNHPD in a safe and secure fashion.  Benefits include:

  • Easy to use no fee system
  • No paper involved, all documents transmitted  are electronic copies (including the Product Licence)
  • All correspondence, along with responses and inquiries, will be done through a distinct submission-specific conversation;  the history of applications is in one location and readily viewed
  • Multiple designated contacts can view and respond to the same conversation
  • Security and confidentiality is maintained in the protected system

Do I have to check epost Connect often?

When you are sent a message on epost from NNHPD, 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 message via a visual icon.

What is the difference between having an epost account and being a Trading Partner?

If you are a Trading Partner, you can submit new applications electronically (for: products, sites, clinical trials, master files) via a specific conversation in ePost without signatures on the document, as becoming a Trading Partner associates your signature with your email address.

If you are not a Trading Partner you can still receive and reply to submission correspondence from NNHPD electronically via epost Connect.  New applications will not be permitted through this channel without a Trading Partner agreement, as per above.  To submit new applications, you must continue to do so by mail or courier in this case.

Become a Trading Partner at any time by referring to the Guidance Document on How to Interact with the Natural Health Products Directorate Electronically

How do I let NNHPD know to send correspondences to my epost Connect account?

NNHPD’s new standard practice is to send all correspondence via the epost connect system.

NNHPD will use the email address of the application contact(s) on the ePLA form. Please ensure that this address is the same as the e-mail associated with your epost Connect account.

Can I share my epost Connect e-mail with other users?

No. 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.

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