In order to sell a Natural Health Product (NHP) in Canada you’ll require an NPN. NPN stands for Natural Product Number, which is a product license that is issued by the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada. The NNHPD oversees all NHP applications submitted in accordance with the Natural Health Products Regulation (NHPR). Here are our top 5 tips to successfully secure an NPN number:
Determine the Correct NPN Classification
For starters, obtaining an NPN can take anywhere between 60 days to 210 days depending on the class of the application. There are 3 different classes of an NPN applications, Class I, II or III. Determining the correct class of NPN application is extremely important, if the class is not identified correctly the application may be refused. Learn more about the different NHP application classes here: The Difference between a Class I, II and III NHP Application
Knowing the Risk of each NPN
The NNHPD has developed what is known as a Compendium of Monographs. These monographs are used to support NPN applications and can speed up the evaluation of safety and efficacy for certain medicinal ingredients. Class I and II NPN applications are supported entirely with NNHPD monographs, which makes them very low risk when complying strictly to these monographs. Class III NPN applications often have the most risk. This is because these NPN’s usually fall outside of these monographs and therefore require additional safety and efficacy studies.
Having Enough NPN Evidence – Class III Only
For Class III applications additional safety and efficacy studies are required for any new novel ingredients or claims. Class III NPN’s also includes partially referencing monograph information but they go beyond the parameters established in the monographs. This ensures that there is enough high-quality evidence to really assist Health Canada in evaluating and approving the NPN.
Prompt Responses to Information Request Notices (IRNs) – Class II and III
For Class II and III NPN applications Health Canada will sometimes require additional information during their review. These requests are called IRNs which are time sensitive and comes with a specific deadline, if the information is not provided to Health Canada by the specific deadline the NPN application will be refused. Ensuring all necessary information is provided to Health Canada in a timely manner will prevent avoidable refusals.
Proper NPN Administrative Documents
Finally, making sure to have all the proper administrative documents prior to submitting an NPN application. This is immensely important as having insufficient documents can lead to an NPN administrative refusal. This will require you to re-submit an entirely new NPN application which can cause further delays in getting an NPN insurance.
All Natural Health Products (NHPs) sold in Canada are subject to the Natural Health Products Regulations (NHPR). Natural Health Products have 3 different classes of application – Class I, II and III.
Determining the correct Class of NHP is important, and if the class is not identified correctly the application may be refused. Learn more about the different NHP application classes here: The Difference between a Class I, II and III NHP Application
The NNHPD has developed what is known as a Compendium of Monographs. These Monographs are used to support NPN applications and can speed up the evaluation of safety and efficacy for certain medicinal ingredients. Class III applications usually fall outside of these monographs and therefore require additional safety and efficacy studies. For Class III applications a rationale should be provided for not attesting to the monograph(s).
Components of a Class III Product Licence Application (PLA)
Class III applications are comprised of general, traditional, and homeopathic applications requiring full assessment (not captured in Class I or II) and can include:
Products with a novel preparation and/or dosage delivery system presenting unique safety and/or efficacy profiles
Applications referencing a Master File to support safety, efficacy and/or quality
Products with ingredient combination issues that may require safety assessment
Partially referencing monograph information but going beyond the parameters established in the relevant monograph(s)
Homeopathic applications with specific claims
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In a Class III application, the following are required as part of the Product Licence Application:
Web-based NHP PLA form – Applications for new products must be provided using the web-based NHP PLA form while amendments to existing products can be submitted using the Amendment and Notification Form (ANF)
Label text – all PLAs must include a label text that meets all the requirements outlined in the NHPR section 93-94. The label text generator within the PLA form can be used
Evidence summary report – To meet all safety and efficacy requirements summary reports are submitted to help assist all class III applications. summary reports serve to reflect the totality of available information relevant to the NHP and provide context that speaks to what may otherwise appear as gaps/uncertainties in the information concerning the safety, efficacy, and/or quality of the product
Finished Product Specifications (FPS) – Class III applications require an FPS, this should attest to specifications in the Quality of Natural Health Products Guide
Once Health Canada has assessed an NHP and decided it is safe, effective and of high quality, Health Canada issues a product license along with an eight-digit Natural Product Number (NPN), which must appear on the label. This number lets you know that the product has been reviewed and approved by Health Canada. Class III applications have a processing time of around 210 days. Find out What to Expect After Submitting an NPN Application.
Our Experts at Quality Smart Solutions are here to help and offer any NHP-related regulatory advice and support on submitting your NPN applications, keeping your product license updated, and reviewing your NHP labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here:
What to Expect After Submitting an NPN Application
In order to sell a Natural Health Product (NHP) in Canada, you require an NPN. NPN stands for Natural Product Number, this is a product license that is issued by the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada. The NNHPD oversees all NHP applications submitted by the Natural Health Products Regulation (NHPR).
For starters obtaining an NPN can take anywhere between 60 days to 210 days depending on the class of the application (Class I, II, and III). Safety, efficacy, and quality of products and ingredients are important. The NNHPD has developed what is known as a Compendium of Monographs. These Monographs are used to support NPN applications and can speed up the evaluation of safety and efficacy for certain medicinal ingredients. Determining the correct Class of NPN application is important, if the class is not identified correctly the application may be refused. Learn more about the different NHP application classes here: The Difference between a Class I, II, and III NHP Application
What comes next after you have successfully submitted your NPN application?
Administrative Verification
The NNHPD will verify the NPN application and screen for any deficiencies. You will receive a Notice of Refusal if the application contains any issues or deficiencies. Class II and III applications that meet all screening requirements will receive an Application Acknowledgement Letter before proceeding to the regulatory screening stage. The acknowledgment letter will contain more information regarding the application, you will receive the official date of receipt of the application and a five-digit submission number. This submission number will be important for future communications with Health Canada regarding your application.
Information Request Notice
The NNHPD will provide you the opportunity to address any non-administrative deficient or missing deficiencies through an Information Request Notice (IRN), as per Section 15 of the NHPR. The IRN will contain a specified response time between 2 to 15 calendar days depending on the information being requested.
Class I applications: may be issued an IRN for brand names or other non-significant deficiencies
Class II and III applications may be issued an IRN for non-significant deficiencies during the regulatory screening stage
Class III applications may be issued IRNs during the assessment stage
Regulatory Screening
After the applications have undergone administrative verification, all NPN applications will be screened against all regulatory requirements mentioned in the NHPR. The application will be screened against all parameters of the NNHPD monographs, and a Notice of Refusal will be issued, if there are any significant deficiencies during the screening process.
Significant deficiencies include:
Incomplete or inaccurate information on the product license application form
Missing mandatory application requirements, such as FPS, product label text, supporting evidence for safety and/or efficacy, letters of access, animal tissue form, and/or attestation forms
The product does not meet the definition of an NHP
Did not meet the parameters of an NNHPD monograph to which the product attested
A Notice of Refusal will also be issued if you do not submit the requested information in response to an IRN within the timelines specified in the notice.
Safety and Efficacy Assessment (For Class III NPN Applications Only)
Upon successful completion of the regulatory screening process, all Class III applications will be further assessed for the safety and efficacy requirements. A Notice of Refusal will be given during assessment if the IRN is not submitted within the timelines specified by Health Canada.
Withdrawal of an Application
At any time during the application process, you may withdraw the application by submitting a request to the NNHPD or if the withdrawal is in response to an IRN response, to the submission coordinator via epost Connect™. Any withdrawals will be acknowledged in writing, if you wish to re-submit the application in the near future the application will be treated as a new application.
Decision Issuance
Once NNHPD has completed the processing of a Product License Application (PLA) they will come to a regulatory decision of either giving you a product license or refusal.
A Product License will be issued for applications that meet all the regulatory requirements outline in the NHPR. The Product License will include an eight-digit NPN, or Drug Identification Number-Homeopathic Medicine (DIN-HM) assigned to the product and this number is required to be present on the front panel of the NHP product label. Lean more about what is required on an NHP label here: The Components of an NHP LabelAll licensed NHPs can be found online on the Licensed Natural Health Products Database (LNHPD) website the status of the licensed product on the LNHPD will appear as “Active”.
A Notice of Refusal will be issued for applications that do not meet the requirements of the NHPR. A reconsideration is available if you choose to make a valid argument against the refusal. If you wish to submit additional information for the product which you received a Notice of Refusal, a brand-new application must be submitted.
Post Licensing Activities
After you have successfully received your NPN what if you need to make changes to your product or license? Post licensing activities include everything from making a fundamental change to the product formulation, changing the dose, changing the brand name, or discontinuing a Product License. Contact us to learn more about what’s required for these post license changes.
Our Experts at Quality Smart Solutions are here to help and offer any NHP-related regulatory advice and support on submitting your NPN applications, responding to potential IRNs, keeping your product license updated, and reviewing your NHP labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: https://qualitysmartsolutions.com/contact/
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