Natural Health Products (NHP) Licensing Regulations & Solutions
NHP Health Canada
Natural health products include goods like traditional medicines, probiotics, minerals and vitamins that are sold in Canada. To qualify as NHPs, a product must be safe for over-the-counter usage. Before these items with NPN health Canada number may be sold, Health Canada must evaluate them and provide a licence.
NHP Regulations apply to each natural health product (NHP) in Canada. For commercial sale in Canada You must adhere to NHP Regulations if you deal with the production, packing, labelling, or importationing NHPs. A Homeopathic Medicine Number (DIN-HM) or Natural Product Number (NPN) licence with 8 digit identification number is given out following Health Canada's approval of the NHP. You can sell NHPs in Canada after an NPN licence registration. Do you want to know what are Natural Health Product Regulations in Canada are? call Arora Consultancy, Canada's best NHP consulting expert for licenced NHPs, right away to get your NPN.
Importance of NHP Licensing
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Regulatory Compliance
NHP licensing ensures compliance with Health Canada's safety, efficacy, and quality standards, reassuring consumers of product safety.
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NHP LABEL COMPLIANCE
To inform consumers that the NHP has been examined and approved by Health Canada, an NPN must be present on the label.
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NHP ECOMMERCE GROWTH
Retailers who want to sell their NHPs on platforms and websites like Walmart, Amazon, and others, require Health Canada NPN license.
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NHP INTERNATIONAL EXPANSION
Many nations acknowledge Canada's regulatory standards & NPN licence similar to or faster than a licence in their nations.
Requirements to Sell NHPs in Canada
Natural Product Number
You must obtain a Natural Product Number (NPN). Health Canada gives a product license and an eight-digit NPN, or homeopathic medicine number, after evaluating a product and concluding it is safe, effective, and of high quality (DIN-HM). This number informs you that Health Canada has examined and authorized the product. Depending on the kind of application, the time it takes to issue a license might range from 60 days to 7 months. The primary display screen of the NHP must display the NPN or DIN-HM.
NHP Compliant Label
Before being sold in Canada, all Natural Health Products (NHPs) must be bilingual (English & French) and labeled/packaged in accordance with the Natural Health Products Regulations. Included are the NPN on the main display screen, a list of the active ingredients in medicine (in either tabular or linear style), usage instructions, a suggested use or use, dangers and warnings, and other information. In order to effectively calculate the amount of label space required to accommodate necessary product information, bilingual labelling should be taken into consideration early in the label and packaging creation process.
Licensed Importer of Record
An importer of record with a current Health Canada site license is necessary for NHPs made outside of Canada. The NHP being imported has to arrive to a storage or warehouse location that is part of the importer's site license. Additionally, the foreign production facility must swear to following Good Manufacturing Practices and be attached to the importer's site license (GMP). NHPs made in Canada don't need to be imported, but they must be produced, packed, and labelled in a location that has a current site license for the required activities.
NPN Canada (Natural Product number)
More than 10000 NHP Successfully Licensed
Natural Health Products NHP Site Licensing
It should be noted that the site license of a Canadian importer must be annexed by all packagers, international makers, and labelers of natural health products.
We have a 100% client satisfaction score and have helped numerous businesses obtain a site license for natural health products. In order to ensure that our clients can comply with the site licensing requirements and good manufacturing practices, we have assisted them in creating NHP license applications, SOPs, and supporting documentation. We help with:
- creating and implementing quality systems that adhere to GMP
- developing reports for quality assurance
- conducting GMP audits for good manufacturing practices
- extending site licenses for NHP
- preparing site license dossiers for NHP
- helping with NHP site license modifications
- annexations of NHP site licenses for overseas sites
Importance of NHP Site License
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A site license is a proof that your site abides by GMP (Good Manufacturing Practices)
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Site licensing demonstrates that the Canadian market only sells safe, superior NHPs.
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With the license, you can rise to the top in your field.
NHP Compliance Solutions
Formula Development
NPN License Registration
Since our founding, we have successfully registered more over 10,000 NPNs, and as a result, we have developed competence in creating all classes of Natural Health Product (NHP) License Applications in a time- and money-saving way.
New Ingredient submission (NHPID)
If one of your ingredients is missing from the database or if a non-medicinal ingredient is present but not added to a function designated for usage in the product,new ingredient request submission is prepared by us.
French Translation
We have French translators team with experience of 30 years. So package Includes both English and French language solutions.
NHP Master File Submission
Health Claims Substantiation
Advertisement and Media Compliance
International Trade Certificate (ITC)
Site Licensing
Clinical Trials Application
Importer of Record
Amazon Seller Compliance
Frequently Asked Questions - NHP (FAQ's) !
What is the cost of registering Natural Health Products with Health Canada?
The cost of registering Natural Health Products with Health Canada can vary depending on various factors such as the complexity of the product, the type of application being submitted, and any additional services required. It is recommended to consult with a regulatory consultancy firm like Arora 297 Consultancy for a personalized quote based on your specific needs.
Can I get an NPN for a protein bar or beverage with herbs and vitamins?
Yes, it is possible to obtain a Natural Product Number (NPN) for a protein bar or beverage that contains herbs and vitamins, provided that it meets the requirements set by Health Canada. The product must comply with the Natural Health Products Regulations and undergo a thorough review process.
What are your costs for NPNs registration?
The costs for NPN registration can vary depending on the complexity of the product and the services required. Arora 297 Consultancy offers customized solutions and pricing options tailored to your specific needs. It is advisable to contact them for a detailed cost assessment based on your product requirements.
Can I just acquire an NPN and start selling my current supplement package in English in Canada?
Acquiring an NPN is an essential step in ensuring the regulatory compliance of your supplement package in Canada. However, obtaining an NPN alone does not guarantee that you can start selling your product. You must also comply with other applicable regulations, such as labeling requirements and Good Manufacturing Practices (GMP), to legally sell your supplement package in Canada.
Will Canada approve the sale of my dietary supplement?
Health Canada evaluates dietary supplements based on safety, efficacy, and quality criteria. While they strive to provide an efficient review process, the approval of a dietary supplement is determined on a case-by-case basis. It is crucial to ensure that your product meets all regulatory requirements and undergoes the necessary assessment to obtain approval for sale in Canada. Working with a regulatory consultancy firm like Arora 297 Consultancy can help you navigate the process and increase your chances of approval.
