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NPN & the NHPID Top 6 Things to Know

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.<br><br>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 <br>

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NPN & the NHPID Top 6 Things to Know

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  1. Top 6 things to know about Natural Health Product Ingredient Database (NHPID) and Natural Product Number (NPN)

  2. What is Natural Health Products Ingredients Database (NHPID)? The Natural Health Products Ingredients Database (NHPID) is an electronic tool that contains collection of pre-cleared information on natural health products.

  3. Top 6 things to know about NHPID • 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. • NHPID user interface allows 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). • 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 purposesetc.

  4. Top 6 things to know about NHPID Contd.. • NHPID is also a great repository of pre-cleared information (such as single ingredient monographs and product monographs) for the customers. • 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. • Currently NHPID excludes information related to product names; proprietary flavours; health claims; risk information and evidence information. • Clicking the “What's New" button at the top of NHPID web application directs the user to web page identifying recent additions to the database.

  5. What is 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 for 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 licence application , NNHPD issues a product license along with an eight-digit Natural Product Number (NPN).

  6. Top 6 things to know about NPN • As per the guidance document for labelling of Natural Health Products, product Number or NPN must be clearly identified on the Principal Display Panel of a NHP label by the prefix NPN. • The Licensed Natural Health Products Database contains information about natural health products that have been issued a product license by Health Canada. Natural Product Number (NPN) can be used to identify licensed natural health products by looking for the eight-digit. • 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 new application and upon approval by NNHPD receive new NPN. These changes primarily include change to the quantity of a medicinal ingredient per dosage unit, change to dosage form or route of administration.

  7. Top 6 things to know about NPN Contd… • Post licensing changes that can be made to an existing NPN include Amendments and Notifications. • Amendments are post-licensing changes to a 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 recommended duration of use; a change in recommended dose; a change in recommended duration of use etc. • Changes that do not have a significant impact on safety, efficacy and or quality of the NHP for which NPN was previously issued are regarded as notifications. It is license holder’s responsibility to notify NNHPD of the change with 60 calendar days after the day change was made. This can be done using ANF. Examples of such changes include addition or substitution of a non-medicinal ingredient, change in brand name of product etc.

  8. Working with a third-party consultancy • www.qualitysmartsolutions.com • www.NHPLicenseExperts.com • www.QualityIMPORTSolutions.com • www.CannabisLicenseExperts.com 1.800.396.5144

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