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: https://qualitysmartsolutions.com/contact/