What are Natural Health Products
A ‘Natural Health Product’ (NHP) refers to a range of products that are used to prevent or treat a condition, to reduce health risks, or to maintain good health. Unlike prescription drugs, NHPs are sold as over-the-counter products for consumer use. Common NHPs include vitamins, workout supplements, plant & herbal remedies, traditional & homeopathic medicines, and certain non-prescription drugs & disinfectants.
Since 2004, all natural health products sold in Canada are subject to the Natural Health Products Regulations. Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) is the regulating authority for NHPs and non-prescription drugs in Canada.
What is an NHP Site Licence?
The Natural Health Product site licence is issued by the Natural and Non-prescription Health Products Directorate (NNHPD), and it allows the licencee to manufacture, package, label, or import NHPs to be sold in Canada.
Importers of NHPs include individuals or businesses who:
- Brings a finished NHP into Canada for the purpose of sale.
- Ship products directly to retailers.
- Are retailers who have imported products themselves for the purpose of sale.
NHP site licence holders must maintain distribution records, manage product recalls, as well as handle, store, and deliver products in compliance with all related good manufacturing practices (GMP).
GMP’s ensure that products meet quality and safety standards from manufacturing to final distribution of the NHP. Importers that are bringing in NHPs from foreign sites must ensure that the NHPs being imported into Canada are coming from GMP compliant facilities. GMP provisions are imbedded within all of the following:
- Product specifications
- Premises
- Equipment
- Personnel
- Sanitation program
- Operations
- Quality assurance
- Stability
- Records
- Sterile products
- Lot or batch samples
- Recall reporting.
Application Requirements
Site licence applications must include the following:
Site Licence Application (SLA) Form:
The SLA form details the following information:
- Applicant’s name, address, phone number, and, if applicable, fax number and email address.
- A statement of the activities (manufacturing, packaging, labelling, importing) the applicant plans to conduct.
- If manufacturing, packaging, or labelling a natural health product, the address of each building where these activities will take place.
- If importing a natural health product, the address of each building where the product will be stored.
- For each activity specified, a statement indicating whether it involves a sterile dosage form.
- A report from a quality assurance person confirming that buildings, equipment, practices, and procedures are compliant.
Designated Party Authorization (DPA) Form:
Applicants/licencees who have authorized a third party to file submissions with the NNHPD on their behalf must submit a Designated Party Authorization Form. This form must be submitted with each application and updated if the designated party changes.
Evidence of GMP Compliance:
This can be shown by providing either a certificate from a qualified authority or a completed Quality Assurance Report (QAR).
The QAR serves as the applicant’s attestation that the site meets all GMP requirements. The QAR form is prepared by the quality assurance person responsible for the site. This person must have the training, experience, and technical knowledge related to the activities conducted and GMP. The report is based on an assessment against GMP requirements outline-d in the Good Manufacturing Practices guidance document. It is valid for one year from the date of completion by the quality assurance person.
The Supplementary Quality Assurance Report (SQAR) form, when applicable, must be completed by manufacturers of homeopathic NHPs and submitted along with the standard QAR. This form includes additional GMP requirements for homeopathic medicines, as outlined in Appendix 1 of the Good Manufacturing Practices guidance document. The SQAR is also valid for one year from the date of completion by the quality assurance person.
Site Licence Expiry and Renewal
Site licences expire after one year from the date of issuance or renewal. The natural health product licence holder will need to submit a complete licence renewal application within the designated time frame that can be found in ‘Table 1’ here.
It’s a licence holder’s responsibility to renew their natural health product licence, and there will be no reminders or licence expiry.
What is a Product Licence?
All natural health products (NHPs) available for sale in Canada must have a product licence before they can be marketed and sold. Applicants must provide Health Canada with comprehensive details about the product before they can get their Natural Health Product Number, more commonly known as an NPN number in Canada, including:
- Medicinal ingredients
- Source
- Potency
- Non-medicinal ingredients
- Recommended use
There are seven distinct application types for obtaining a product licence, each with specific submission requirements:
- Compendial (can include traditional and/or non-traditional claims)
- Traditional Claim
- Non-Traditional Claim
- Homeopathic
- TPD Category IV/Labeling Standard
- Homeopathic DIN
- Transitional DIN.
Learn more about product licence application specifics here.
How CannDelta can Help!
CannDelta will help your business build world-leading strategies in the natural health product industry. We will complete your site or product licence application and help your business become fully operational. From legalization to large-scale research and development, CannDelta works with industry experts to achieve a better, more profitable future for the regulated and scientific community worldwide.
Prepare and Complete a Health Canada Application Package: Spend more time producing your NHP while CannDelta handles the application. We’ll take care of the entire process and compile the necessary information about your site, personnel, activities, and more. CannDelta also provides optional supporting documents like standard operating procedures.
Regulatory Compliance Consulting: CannDelta offers expert advice and guidance on meeting federal natural health products regulations in Canada for facilities, systems, and procedures. CannDelta will also assist with other aspects of the application and project by recommending contractors, joining conference calls and more.
Submission & Communications: CannDelta will submit the natural health products site license or product license application package on your behalf! We will also communicate with Health Canada reviewers before and after submission to discuss the application package.
Response to Health Canada Inquiries: Address Health Canada’s requests for more information or notices of intent to refuse by adjusting the application package as needed, working closely with your executive and facility design teams.
Ongoing Regulatory Support: CannDelta provides continued regulatory assistance until the licence is granted, focusing on ensuring all aspects of the licence application meet requirements.
Marketing Plan:
Let your brand stand out! We assist in building your brand and devising outreach strategies to make your NHP stand out!
Fill out a form below to get in-touch with our Delaware cannabis consultants today!
Frequently Asked Questions
How Do I Register a Natural Health Product in Canada?
You will need a natural health product license to register and sell an NHP in Canada. Every natural health product must pass a pre-market evaluation to verify its safety, efficacy, and quality. To demonstrate these aspects, evidence must be provided to Health Canada through a product license application for each individual product.
How Do I Get a Natural Health Product Licence in Canada?
To get a natural health product site licence or product licence in Canada you must submit a complete and comprehensive application. With a site licence you can have a business and facility that manufactures, packages, labels, and/or imports NHPs. A product licence allows you to market and sell NHPs. Each of these licences has different application requirements. You will have to submit the appropriate application and supplemental requirements depending on what you are trying to achieve.
What Is Considered a Natural Health Product?
A ‘Natural Health Product’ (NHP) is a product used to prevent or treat ailments, reduce health risks, or maintain wellness. Unlike prescription drugs, NHPs are over-the-counter items such as vitamins, workout supplements, herbal remedies, traditional and homeopathic medicines, and some non-prescription drugs and disinfectants. All NHPs must be produced, sold, imported, and marketed to natural health product regulations in Canada.
How Do I Get a Natural Health Product Number?
To get a natural product number/ NPN number in Canada you need to apply for a product licence. This will require various details about your product and an accurate application submission.
