1. What is the NHP Licensing Process/what is needed for it?
This process involves the submission of a product license application to Health Canada.
Ø Documents normally contained within a submission are Cover Letter and a Product license Application form. Other documents may be required based on the classification of the product and who is applying, depending if this is the applicant or a third party.
Ø Other documents that are submitted are the Designated party authorization form or DPA. Senior Official Letter, Finished Product Specification form. Monograph attestation form. Efficacy safety summary report and research articles, if applicable.
Ø After project quoting and onboarding we proceed to Formula Review
Ø At Quality Smart Solutions we review your labels, formulas, and raw material certificates of analysis before ensuring an agreeable and accurate submission.
Ø We also use the process to ensure you are well informed as a future license holder.
Ø Formula review is where we provide a document with any questions or requests regarding outstanding information that is crucial to the application. Or items that Health Canada may question.
Ø We discuss attestation to monographs and any research requirements to support safety and efficacy.
Ø We also discuss health claims here.
Ø After completion and agreement for the formula review, we proceed to draft the application for you. With all associated forms.
Ø Then it undergoes an internal quality audit before being provided to the applicant for their review and approval.
Ø Please know that more recently Health Canada has made site information a requirement on application forms. We will request this during the process as well.
Ø This means adding manufacturer, packager, labeler, warehouse, and importer information to the application or marking the form as hypothetical.
Ø Then once all is approved we apply to Health Canada via epost.
Ø Health Canada will review the application and reach out if any details or confirmations are required via an information request notice or IRN.
Ø After everything is addressed then you will be assigned a licensing decision. Your NPN!
Ø Should you need to make any changes you can submit notifications (minor change) amendments (major change) or a new application (fundamental change).
Ø Quality Smart Solutions is happy to look into your projects and help with applications of all classifications.
2. Why should someone get an NHP License?
Ø An NHP License is a Legal requirement for the sale of Health Products in Canada. Along with site licensing, a compliant bilingual label is another requirement.
Ø Essentially If your product is best classified as a Natural Health Product you will need an NPN to market it in Canada.
Ø Classification is the first step to deciding how to proceed with your product.
3. How long will it take to receive my Natural Product Number (NPN)?
Ø This depends on the classification.
Ø There are three classes for NHPs, classes 1, 2, and 3.
Ø One being the most simple and 3 being the most complex.
Ø Class 1 which means all ingredients and claims align with 1 Health Canada monograph is posted to take 60 days.
Ø Class 2 which means all ingredients and claims align with 2 or more Health Canada monographs is posted to take 90 days.
Ø Class 3 which means any one ingredient steps outside the Health Canada monographs is posted to take 210 days.
Please know that Health Canada currently has a queue for applications and we caution our clients that the review timeline can be somewhat longer than what they have posted.
4. Is there a government fee associated with licensing Natural Health Products?
Ø At this time there are no fees associated with submitting a Health Product License application to Health Canada.
Ø This would be beyond fees that are paid to a consultant to assist, prepare and submit the application.
Ø That doesn’t mean that Health Canada will not arrange a cost recovery program in the near or distant future, this concept has been discussed previously.
Other similar application pathways have cost recovery in place and we could see how this could be transitioned to this category eventually.
5. Do NHPs need to be tested?
Ø Yes Health Canada has posted several guidance documents explaining and detailing testing requirements for Natural Health Products.
Ø This is an effort to ensure products are safe and effective.
Ø Testing can be broken down into finished product testing and stability testing, both of which are required.
Ø Some testing that is required is physical testing, medicinal ingredient assay, medicinal ingredient identity, microbiology, heavy metals, pesticides, solvents, and ingredient-specific tests.
Ø Some testing can be confirmed at the raw material stage. But some must be done at the finished product stage.
Quality Import solutions offer testing gap analysis to assist in Canadian compliance with testing requirements.
6. What recent changes has Health Canada made to the Natural Health Product Regulations (NHPR)?
Ø July 2022 Health Canada announced changes regarding updating labeling regulations to include Productthe Facts table, updated font size requirements, and modernizing contact information.
- Previously information was in free form and we suggested they be listed as statements or sections. Now they are standardizing content to appear more like a drug in a boxy black and white facts table.
- Previously there was no font minimum and text was to appear as legible to the average eye. Now you must show a 5.5-6 point font.
- Updates to license holder and importer information can now include a phone number, website, or email rather than postal information.
- Please know that license holders for the product approved before July 2022 will have several years to comply with these new label requirements. 3 years for NPNs issued after July 6. and 6 years for NPNs issued before July 6, 2022.
- As well as the recent requirement to add site information to the application form is now required.
- If no site information is marked, the application is considered hypothetical and may be deprioritized.
- Also there are changes to Single mineral products that should now show the total salt amount and elemental amount such as zinc and zinc oxide amounts. This is to ensure the consumer is getting the proper information for the dose amount of elemental mineral.
- We are happy to review your labels for regulatory and bilingual compliance.
Natural Health Product Business Development Questions:
7. How long of a lead time does I need when planning for a production run?
- Give yourself lots of time, there are many variables that need to be managed and aligned (Price quotes, purchase orders placed and confirmed, materials purchased, tested, manufactured, packaged, finish product testing)
- First-time runs will require 12-14 weeks
- Next runs will take 10-12 weeks.
Need help with your Natural Health Products (NHP/NPN)?
8. Does my brand need to provide the raw materials or does a manufacturer like Acenzia source them?
This is the customer’s prerogative. We offer complete turn-key services or a la carte (just product design, manufacturing pills or powders, just coating, just blending, just bottling)
9. What are the biggest challenges you face with NHP brands seeking a manufacturer?
Choosing the right manufacturing partner is very important. Be sure to look out for the following criteria:
- They must be a third-party Audited GMP facility – Health Canada has in the past done a few on-site inspections – choose a partner that proves their confidence/commitment to quality – look for FDA, NSF, other – ask for the report and corrective actions required
- Do a walk-through yourself – how does it look? Would you give your loved one’s products from the facility?
- Responsive, high operating Quality, operations, warehousing, and sales teams that get you answers?
- Partner in compliance – formulations, finished product specs and testing, packaging compliance & specs, shelf life, answering consumer questions about formulas, what if a recall happens, are you ready? Do you have a shelf life program?
- Manufacturing capacities availability – do they have time to fit you in or do they have other overbearing commitments – do they have the brands that they manufacture before you?
- Formulations – do they have a formulations team? Do they do trials/benchwork? Do they charge for this work? Do you own your formulas/flavors? Know what every ingredient is called and where to get them.
- They must be a third-party Audited GMP facility – Health Canada has in the past done a few on-site inspections – choose a partner that proves their confidence/commitment to quality – look for FDA, NSF, other – ask for the report and corrective actions required
In summary, don’t go for the cheapest quotes! Seek to understand the value you’ll be getting for your money. Everything you need costs money.
10. How is Acenzia dealing with / assisting customers with the continued supply line challenges?
- Acenzia has a deep network of suppliers and has found alternative suppliers
- Become forecasting experts together – book purchase orders asap – give yourself lots of time to avoid disappointment / extra costs
- Recommending alternative options
- Airfreighting materials in if they are needed in a rushed timeline
You need to build deep relationships with qualified suppliers that can give you exactly what you need for your business’s operations. Acenzia has a diligent process for both forecasting supply chain issues and choosing the suppliers they work with. The sooner you tell them about your requirements the better chance they’ll have of getting you what we need. their supply, formulation, and quality team are also experts at suggesting alternative solutions. If things are being held up they have emergency freight solutions. Ultimately it comes down to ownership of your product, cost considerations, forecasting, and planning. Finally, this is a lot easier when you have a great relationship with your suppliers.
Natural Health Product Retail Questions:
11. What retail opportunities are there in Canada for NHPs?
All Food, Drug & Mass Retailers (over 8,000) in Canada have a “wellness section” where they sell vitamins & supplements (NHP products). There are also over 2000 Independent Health Retailers (IHR) across the country.
12. What are some of the retail requirements to sell NHPs? (eg. Costco requires special corrugated boxes, unit sizes may need to be customized, listing fees, etc).
- In the Food & Drug channel, the most significant requirement is listing/slotting fees.
- Costco requires Club Pack
13. How do I bring products into my country by shipping directly to a retailer? Do my products need to land at a site-licensed facility first?
According to Health Canada, all sites involved have to be an annexed licensed site or a foreign site until it’s released. Our sister company Quality Import Solutions can help you with this.
Even if you can ship from your facility outside of Canada directly to the retailer, distance and lead time would make that strategy prohibitive. Retailers expect to be able to replenish easily and quickly, especially if their strategy is on-demand inventory.
14. How should I best enter the Canadian market if I’m a start-up?
- Proof of Concept – if you are launching an entirely new brand/product and need proof of concept, we would recommend launching in the IHR channel because they will provide wonderful feedback.
- Consider your path to success so far; we recommend that you duplicate your path to success as you enter the Canadian Market. For example, if you started in IHR and built your brand that way, we recommend you start in IHR as well.
- Consider who your end consumer is and where they shop.
These steps will guide you on how to best enter the Canadian Market.
15. Can I get a commitment from retailers before I invest in the NPN process?
No. Canadian Retailers expect that you have done all of the leg work before presenting for their consideration.
Natural Health Product Manufacturing Questions:
16. How do you guarantee quality Natural Health Products?
- Vendor Qualification process
- Raw materials testing/micros/assays, heavy metals, etc
- In process controls and testing
- FPS/testing
17. How does shelf life work? How is it determined? Who is responsible for shelf stability data?
- the product owner is responsible for the shelf life study and assigning the shelf life of the final product
- Acenzia can assist with your shelf life study and monitor the shelf life of the final product quality before the expiration date.
18. How do NPN amendments/notifications work?
- Most of the time the customer wants to know the amendment or notification procedure of their NPN if there is a change of formulation and other information
- Acenzia will advise for the procedure
19 What are some common Amazon de-listing issues for NHPs?
A few common de-listing issues with Amazon Quality Smart Solutions has seen is miscategorizing protein powders as NHPs when they can be considered a food product. Another one would be cosmetics being mispositioned as NHPs (often driven by claims on the packaging).
How can QSS ensure your NHPs are compliant and transported without the worry of rejection?
Working with regulatory consultants such as Quality Smart Solutions and Quality Import Solutions will help bring your products into Canada in a safe and compliant manner. We hold an NHP Site License which allows us to import products and annex foreign sites for our clients. Please reach out to our team of specialists for all your NHP regulatory needs!
Special thanks to Brewin and Associates and the Acenzia Team for their expertise in this panel.
