What 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 about Natural Health Products, and hence NHPID is a critical tool for the Natural Health Products Online System.
What is the Natural Health Product Database?
The Natural Health Product Database is an online database maintained by Health Canada. It contains information on the safety, effectiveness, and quality of thousands of natural health products. It also features product labels, listing information including sources, ingredients, and directions. By using the Database, you can get fast facts on specific products or search more broadly to compare different natural health products to find the best option for meeting your needs.
How to Use the NHPD Database for Your Research?
The Natural Health Product Database can be a great resource for anyone looking to find out more about natural health products. It includes detailed information on thousands of natural health products. To use the Database, start by searching for the product you’re interested in either by its brand name or active ingredients. You’ll then be presented with all the relevant product labels for that product, each containing information on sources, active and non-active ingredients, and directions for use. You can also use advanced search features such as filtering by efficacy or safety ratings.
What are the Regulations and Safety measures for Using Natural Health Products?
Health Canada requires that all natural health products meet strict safety, efficacy, and quality standards. To ensure these products can be used safely and effectively, they are closely regulated by the Natural Health Products Regulations. These regulations cover many aspects of natural health products, including studies for safety and effectiveness, product labels, and manufacturing and advertising practices. When purchasing and using a natural health product, it’s important to always check for valid evidence of its safety and quality.
What are the NHPID regulations?
The NHPID is a comprehensive database containing information on all natural health products authorized for sale in Canada. The database is maintained by Health Canada and is used to regulate the marketing and distribution of NHPs. The NHPID contains information on the ingredients, dosage forms, recommended uses, and safety information for each authorized NHP.
To sell a natural health product in Canada, it must be authorized for sale by Health Canada. This involves submitting a product license application to Health Canada, which includes detailed information on the product’s ingredients, dosage form, recommended use, and safety information. Once the product is authorized for sale, it is assigned a Natural Product Number (NPN), which must be displayed on the product label.
What are the requirements for NHPID product licensing?
Obtaining a product license for an NHP involves submitting a comprehensive application to Health Canada. The application must include detailed information on the product’s ingredients, dosage form, recommended use, and safety information. In addition, the application must consist of evidence to support the safety and efficacy of the product.
The product license application process can be time-consuming and expensive. Still, ensuring your NHP is safe, effective, and compliant with NHPID regulations is essential. Working with a regulatory compliance consultant can help streamline the process and ensure your application is complete and accurate.
What are the labeling requirements for NHPID products?
In addition to obtaining a product license, all NHPs must comply with strict labeling requirements. The product label must include the product name, the NPN, the name and address of the manufacturer, the recommended use, the dosage form, and the list of ingredients. The label must also include any relevant warnings or precautions and instructions for use.
Complying with labeling requirements can be challenging, especially for small businesses that need more resources to hire a graphic designer or label printing company. However, ensuring that your product label is clear, accurate, and compliant with all NHPID regulations is crucial.
What are the advertising and marketing regulations for NHPID products?
Advertising and marketing natural health products in Canada is heavily regulated, and all advertising must comply with the Food and Drugs Act and the Natural Health Products Regulations. This includes ensuring that all claims about the product are supported by scientific evidence and are not misleading or false.
In addition, all advertising must include the product name, the NPN, and a statement that the product is a natural health product. Advertising must also comply with the guidelines set forth by Advertising Standards Canada, which regulates advertising across all industries in Canada.
What are the challenges of NHPID regulation compliance?
Complying with NHPID regulations can be challenging, especially for small businesses that need more resources to hire a regulatory compliance consultant. However, there are several steps that companies can take to ensure that they comply with NHPID regulations.
One of the most important steps is to stay up-to-date with the latest regulations and guidelines. Health Canada regularly updates its policies and regulations, so it’s essential to stay informed and make any necessary changes to your products or labeling.
Another critical step is to work with a regulatory compliance consultant. A consultant can help ensure that your products and labeling comply with NHPID regulations and help with product license applications and other regulatory requirements.
What are the common pitfalls to avoid when dealing with the NHPID regulations?
Businesses should avoid several common pitfalls when dealing with NHPID regulations. One of the most common is making false or misleading claims about the product. All claims about an NHP must be supported by scientific evidence and not be deceptive or dishonest.
Another common pitfall is failing to comply with labeling requirements. All NHPs must have a clear and accurate product label that complies with all NHPID regulations.
Finally, businesses should avoid claiming that their products can cure or treat a specific disease or condition. Health Canada prohibits this, which can result in fines or other penalties.
Top 6 things 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 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 e.g., quality test methods, dosage forms, non-medicinal ingredient purposes,
- 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).
- 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 out and submitted to ingredient_support@hc-sc.gc.ca.
- Currently NHPID excludes information related to product names; proprietary flavors; health claims; risk information and evidence information.
- 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:
- 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.
- 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.
- 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.
- 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).
- 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.
- 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:
Who needs a Foreign Site Reference Number (FSRN)?