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.
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).
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).
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.
For Natural Health Products (NHPs) manufactured, packaged, and/or labeled by sites located outside of Canada, Canadian importers are required to provide evidence that these sites will be at par with Canadian Good Manufacturing Practices (GMP) under Part 3 of the Natural Health Products Regulations (NHPR).
This can be demonstrated using pre-cleared pieces of evidence or other acceptable evidence by the Site Licensing Guidance document. Foreign sites can be added to the site license application of Canadian importers by providing GMP evidence from the foreign site. This evidence is intended to demonstrate that manufacturing, packaging, and/or labeling operations carried out at foreign sites are in accordance with Part 3 of the NHPR.
FSRN thus helps in eliminating the need for a foreign site to provide the same GMP evidence multiple times for each importer’s Site License. It is important to note that a Foreign Site Reference Number is not a site license and hence cannot be regarded as authorization for the direct export of NHPs to Canada.
In a recently issued 4-page bulletin, the Natural and Non-prescription Health Products Directorate (NNHPD) has advised stakeholders regarding the interim measures on new Foreign Site Reference Number applications and renewal/modification of existing FSRNs. This bulletin also sheds light on interim measures for the validity of the Foreign Site Reference Number. If your FSRN meets certain criteria, you may be eligible for a longer validity period (extension).
New Foreign Site Reference Number Applications – These applications will be reviewed upon annexation submission. Application for FSRN will be refused if not linked to a Canadian Importer. This measure is effective until further notice. Approval in the form of a Notice of Acceptance (NOA) will be issued if these conditions are met and the site is compliant. Previously FSRN submissions were reviewed and approved as their own application. Now the Foreign site must be linked to a Canadian importer upfront. Previously lower priority was placed on Foreign Site Reference Number applications that did not link to an importer’s site license. Now there is no mention of priority.
Need a licensed importer for your natural health products?
2. Foreign Site Reference Number Renewal Application – FSRN will be extended until further notice if the site has been inspected by a qualified authority in the last 5 years (e.g., FDA) and there have been no risk issues flagged by a recognized authority (e.g., FDA). FSRNs that were issued based on QAR or SNC from 2020-to 2023 will also be extended.
FSRN holders are required to notify the NNHPD if there are any changes to the site’s GMP that may cause a risk to health, such as a regulatory action.
Each FSRN will be re-reviewed when it is included/linked to a new importer’s submission to ensure there is no risk associated with the site. Previously FSRN sites having expiry dates were required to be renewed prior to that date.
3. Modifications to an existing Foreign Site Reference Number – When submitting changes to FSRN, the information will only be evaluated (in parallel) when the change is also submitted/ initiated by an importer or site license holder. Previously FSRNs were updated and reviewed without being triggered by a site license amendment.
As per these interim measures, the Foreign Site Reference Number holder is responsible for the following:
Providing FSRNA (authorization) form to each Canadian importer
Providing required records to site license holders in a timely manner
Providing required records at the time of site license submission, annexation, and renewal
These requirements are the same as earlier and there are no changes to previous requirements.
According to the interim measures, the Site License holder’s (Canadian Importer) responsibilities include:
Finished product testing and stability studies are conducted in accordance with Part 3 of NHPR and the relevant records are held by the importer
Ensuring that records are available from Foreign Sites in one of the official languages (i.e., English and/or French)
Ensuring that relevant records for production and quality such as Master production documents, recalls, complaints, etc. are retained and readily available
COVID had significantly impacted the processing of NHP product license applications with delays in the processing of all classes of applications with respect to the established service standards outlined in the Natural Health Products Management of Applications Policy. Similar delays were observed for NHP site license submissions. After the worst of the COVID-19 pandemic had passed, the NNHPD ramped up the review process to clear the backlog of non-priority product, site, and post-license submissions. As a result, regular updates are being provided by the NNHPD via the Performance standards for NHP applications Stakeholder Meetings, with the most recent one being March 23, 2022.
For non-COVID submissions (April 2021 to February 2022) 9,297 NHPs were licensed which includes 53% Class I; 13% Class II; 34% Class III applications. 718 sites were licensed/renewed. As per the recent performance standards for Class I applications, 93.4 % of new applications and amendments were processed within the service standard (60 calendar days) while for class II (service standard – 90 calendar days) and class III applications (service standard – 210 calendar days), these numbers were 87.8% and 59.6% respectively.
Post-licensing submissions are subdivided into two categories: amendments and notifications. Amendments are defined changes to an NHP that may have an impact on the safety, efficacy, and/or quality of the product. On the other hand, notifications are defined as changes to an NHP that do not significantly impact the product’s safety, efficacy, and/or quality. Product license amendments follow the service standards as applicable for the relevant class of application while notifications have no established service standards. As per the recent data released on performance standards, 98% and 71% of notifications received in 2021 and 2022 respectively were processed.
Within the past year, the NNHPD has managed to achieve 50% year-to-date performance for new applications and amendments for non-COVID stream I Site Licence Applications while for stream II the numbers were 81% year-to-date performance for new applications and amendments. 318 site licence renewals were completed this fiscal year
System updates for Product Licence Applications
The web-based Product Licence Application (web PLA) form is an integral component of any natural health product license submission package. The basis of developing this web-based platform is to allow web PLA form searches and ease of populating data from the Natural Health Products Ingredients Database (NHPID). Earlier version 3 and version 4 were available. Web PLA version 4 allowed in-form compendial (NNHPD monograph) (class I) validation as opposed to web PLA version 3.
Several system improvements have been implemented to support priorities for Product Licence Applications. New web PLA version 4 was released on April 9, 2022.
With the release of this latest version of web-based PLA, it was announced that web version 3 will be discontinued for new product license applications. Access to NNHPD web PLA previously finalized using version 3 will still be available for responding to IRNs. Also, these version 3 applications will be available for viewing using any browser and responding to IRNs until the end of November 2022.
It was also announced that moving forward, web PLA version 4 will support the selection and population of both validated and non-validated monographs. The validation supported monograph table was removed from the system. Following changes/updates were proposed for the new NNHPD web PLA version 4.
As per the Natural Health Products Management of Applications Policy, class I applications are required to comply with all the parameters of an individual monograph. The number of NNHPD monographs that can be referenced is subject to the maximum of one for class I applications while this number can be two or more NNHPD monographs for class II applications. Earlier web PLA version 3 was recommended for all classes of applications based on non-validation supported NNHPD monographs, but the recent version can be used for all monographs including the ones that are not validation-supported. These monographs will be included in the picklist and marked as “(validation unavailable)”. Such applications will be finalized without validation with the status being displayed as “Not validated”.
Aside from the above changes, several other changes have been made to the web PLA to make it more user-friendly and sensical. For example – the option to choose a dual-route of administration to support aromatherapy submissions, excluding pregnant and breastfeeding risk statements for products intended for male sub-population only, etc.
System updates for Web Site Licence Application (web SLA)
Version 3.0 of the web SLA was released in April 2022. Several updates have been made to make this new version more intuitive and detailed. Some of these changes include the addition of options to include qualification of the Quality Assurance Person, new validation features, the addition of an NPN lookup in the Product Information module, etc.
The ever-present changes with these updates in system and performance standards make it increasingly challenging to keep up with the most up-to-date regulatory information. Planning is a critical component of any product launch or site licensing activities; hence it is crucial to be keep abreast with the impacts of these changes to the plans for your products, sites, and their operational activities.
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.
