NPN & the NHPID Top 6 Things to Know

NPN & the NHPID Top 6 Things to Know

Natural Health Products NPN, NHPID, NHPWhat is Natural Health Products Ingredients Database (NHPID)?

The Natural Health Products Ingredients Database (NHPID) is an electronic tool that contains a collection of pre-cleared information on natural health products. Presently, in Canada, there is a lack of a comprehensive exhaustive primary reference for substances and terms pertaining to Natural Health Products and hence NHPID is a critical tool for the Natural Health Products Online System.

Top 6 things about NHPID:

  1. Presently, the Natural Health Product Ingredient Database can be accessed only through electronic Product License Application (ePLA) forms and Natural Health Products Ingredients Database Web application.
  2. NHPID user interface allows the following 2 types of searches:
  • Ingredient search: This search function allows search for acceptable medicinal and non-medicinal ingredients used in Natural Health Products (NHP). Searches can be made using ingredient names (NHPID names; Proper names; Common names; Taxonomical synonyms (Taxa) or Chemical Abstract Service (CAS) numbers.
  • Controlled Vocabulary Search: This search function allows searches based on standard terminology used by the Natural Health Products Online System for e.g., quality test methods, dosage forms, non-medicinal ingredient purposes,
  1. NHPID is also a great repository of pre-cleared information (such as single ingredient monographs and product monographs) for customers. Pre-cleared information (PCI) is any form of information supporting the safety, efficacy, or quality of a medicinal ingredient or natural health product that has been reviewed and approved by the Natural and Non-Prescription Health Product Directorate (NNHPD).
  2. Changes such as additions and modifications can be proposed to NHPID. To propose a change to NHPID, Natural Health Products Ingredients Database Issue Form needs to be filled and submitted to ingredient_support@hc-sc.gc.ca.
  3. Currently NHPID excludes information related to product names; proprietary flavours; health claims; risk information and evidence information.
  4. Clicking the “What’s New” button at the top of the NHPID web application directs the user to a web page identifying recent additions to the database.

What is a Natural Product Number (NPN)?

In Canada, all Natural Health Products (NHPs) are regulated by the Natural and Non-prescription Health Products Directorate (NNHPD) and must have a product license before they can be sold in Canada. To get a product license detailed information regarded the product e.g. medicinal ingredients, source, dose, potency, non-medicinal ingredients, and recommended use(s), etc. needs to be submitted by the applicant to NNHPD. Upon reviewal and approval of a product license application, NNHPD issues a product license along with an eight-digit Natural Product Number (NPN).

Do you need help obtaining your NPN?

Top 6 things to know about NPN:

  1. As per the guidance document for labeling Natural Health Products, the product Number or NPN must be clearly identified on the Principal Display Panel of an NHP label by the prefix NPN.
  2. The Licensed Natural Health Products Database contains information about natural health products that have been issued a product license by Health Canada. These licensed products have been evaluated by Health Canada and are deemed to be safe and effective. Natural Product Number (NPN) can be used to identify licensed natural health products by looking for the eight-digit.
  3. As per the Natural Health Product Regulations (NHPR), certain post-licensing changes are considered as fundamental changes and cannot be made to the existing NPNs, these changes require a new application and upon approval by NNHPD receive a new NPN. These changes primarily include a change to the quantity of a medicinal ingredient per dosage unit, a change in dosage form, or the route of administration.
  4. Post licensing changes that can be made to an existing NPN include Amendments and Notifications. Amendments and notifications can be made using the Amendment and Notification Form (ANF).
  5. Amendments are post-licensing changes to an NHP that may have an impact on the safety, efficacy, and/or quality of the product. Amendments can only be applied to a product once the change has been approved by Health Canada and the Product License is updated to reflect the changes. Examples of such changes include a change to its recommended dose; a change in the recommended duration of use etc.
  6. Changes that do not have a significant impact on the safety, efficacy, and or quality of the NHP for which NPN was previously issued are regarded as notifications. It is the license holder’s responsibility to notify NNHPD of the change within 60 calendar days after the day change was made. This can be done using ANF. Examples of such changes include the addition or substitution of a non-medicinal ingredient, change in the brand name of a product, etc.

References:

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/online-solution/ingredients-database.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/natural-health-products/natural-health-products-ingredients-database-web-application-guide-november-2008-health-canada-2008.html

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/natural-non-prescription-health-products-directorate.html

How can Quality Smart Solutions serve you?

At Quality Smart Solutions, we have a team of experts who are skilled in NHP compliance. We offer several solutions to meet your needs like NHPID, Health Claims Substantiation, Clinical Trial Application (CTA), etc. Please contact us today or call us at 1-888-933-9551 to learn about how we can help you.

 

 

30 Minute Free Consultation
0/5 (0 Reviews)
This website uses cookies to provide necessary site functionality and improve your online experience. By using this website, you agree to the use of cookies as outlined in Quality Smart Solutions's online privacy statement.