NHP Law Firm in Ontario
In Canada, natural health products (NHPs) are defined as “natural substances that are used to restore or maintain good health” and include products such as herbal remedies, vitamins and minerals, traditional medicines, and homeopathic medicines. NHPs are regulated by Health Canada under the Natural Health Products Regulations, which are part of the Food and Drugs Act (FDA).
Under the Natural Health Products Regulations, a company must obtain a Natural Health Product Number (NPN) before it can sell an NHP in Canada. To obtain an NPN, a company must first submit an application to Health Canada that includes information about the NHP, such as its ingredients, intended use, and the recommended dose. The application must also include evidence to support the safety, efficacy, and quality of the NHP.
The review process for NHP applications can be complex and may take several months to complete. Health Canada will assess the application to ensure that the NHP meets the requirements set out in the Regulations, and will make a decision on whether to issue an NPN. If the NHP is approved, the company will be issued an NPN and can then sell the product in Canada.
There are several factors that Health Canada takes into consideration when evaluating an NHP application. These include the quality and purity of the ingredients, the dosage and strength of the product, and any potential risks or interactions with other medications. Health Canada may also request additional information or require that certain conditions be met before an NPN is issued.
It is important to note that NHPs are not subject to the same level of clinical testing and approval as prescription drugs. However, Health Canada has established stringent standards for NHPs to ensure that they are safe and effective for their intended use.
If you are thinking of launching a Natural Health Product in Canada, you need a law firm by your side that understands the nuances of the Canadian Natural Health Product Regulations. At Harrison Jordan Law, we’re here to help. The Regulations in full can be read here. Keep in mind you will also have to abide by the Food and Drugs Act and any other relevant regulations.
Please note: We assist with client matters related to Health Canada. None of our lawyers work for Health Canada.
Natural Health Products include:
• Probiotics
• Herbal remedies
• Vitamins and minerals
• Homeopathic medicines
• Traditional medicines such as traditional Chinese medicines
• Other products like amino acids and essential fatty acids
NPN Number Consultant and Lawyers
To sell a Natural Health Product in Canada, you need to apply for approval from Health Canada. After reviewing your application, which includes evidence demonstrating the safety and efficacy of the ingredients in your product, Health Canada will issue you something called an NPN, or Natural Product Number, an 8-digit code identifying that the specific product you are applying to Health Canada in respect of. This NPN identifies the product and will be used by you on the label encompassing the package of your product when it is sold to the general product.
Natural Health Products Ingredients Database
Health Canada has maintained a database that contains all medicinal ingredients that can be used in Natural Health Products. THis Ingredients Database is helpful to NHP applicants because it shows if an ingredient has been accepted by Health Canada in the past, and may also contain restrictions that HEalth Canada has imposed on the ingredient. If you are planning to launch a natural health product in Canada, ensure that any ingredients with a medicinal or therapeutic effect are found in this Database. The database can be found here.
What is a Natural Health Product (NHP) in Canada?
Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health. They come in many different product forms such as tinctures, solutions, creams, ointments, and drops. NHPs in Canada are marketed for health reasons, and may include claims that it prevents or treats illnesses or conditions, reduces health risks, or maintains good health.
According to Health Canada, this can include:
• Probiotics
• Herbal remedies
• Vitamins and minerals
• Homeopathic medicines
• Traditional medicines such as traditional Chinese medicines
• Other products like amino acids and essential fatty acids
What is a Natural Product Number (NPN) in Canada?
The Natural Product Number, or NPN, is an 8-digit number that Health Canada assigns to every Natural Health Product it approves in Canada. This code identifies your product and must be included on the outside label on the packaging of your product.
Do Natural Health Products Need to be manufactured according to Good Manufacturing Practices (GMP)?
Yes. NHPs in Canada need to be manufactured according to Good Manufacturing Practices (GMP). Health Canada has published guidance documents that outline how to best achieve GMP standards, which depends on the activities you are conducting.
Can you import an NHP product into Canada commercially?
In certain circumstances, NHPs can be imported commercially into Canada. However, there are some import restrictions contained within the Food and Drugs Act that you need to be aware of if you are thinking of importing NHPs into Canada. You will have to ensure necessary information is submitted to Health Canada so that they can approve your request. You will need to obtain an authorization to sell the product in Canada, as well as obtain an 8-digit Natural Product Number (NPN) before you can import it.
Harrison Jordan is a lawyer assisting businesses on matters related to Natural Health Products in Canada. Harrison Jordan has experience dealing with Health Canada in matters related to NHP/NPNs and can help guide you through the NHP Application process with Health Canada. Call his office at +1 647 371 0032 or email him today via the contact form on this website.
