Food & Drug Regulations (F&DR)
Dell Tech offers expert regulatory, scientific, and compliance assistance across a wide range of industries to get your product to market.
In order to market health products in Canada, manufacturers, private labelers, importers, and distributors must be in compliance with Canadian laws and regulations for the marketing of food, drugs (DIN), cosmetics, natural health products (NHP), and medical devices.
Dell Tech provides clients with regulatory, scientific, and compliance assistance on a broad spectrum of chemical-related issues to help companies market and use products in Canada.
Through our experience and technical expertise, we assist those who need to make sense of the Canadian regulatory system and obtain the required approvals to quickly and efficiently market products in Canada.
Health Canada Regulations
Health Canada, with its internal offices of the Natural and Non-Prescription Health Products Directorate and Medical Devices Bureau, is the Federal Regulatory Authority responsible for the sale of drugs, natural health products, and medical devices in Canada.
Dell Tech consultants have extensive experience with various regulatory submissions to Health Canada and can assist with bringing your products to Canadian market.
Dell Tech’s Health Canada services include:
- NPN and DIN Registrations
- Site License Applications
- NHP applications for OTCs (including vitamins, herbal remedies, homeopathic medicines, hand sanitizers, acne medications, supplements, sunscreen, etc.)
- DIN applications for OTCs (including hand sanitizers, acne medications, supplements, sunscreen, etc.)
- Disinfectant/Sanitizer Review and Registration
- Drug Establishment Licence Applications
- Development of Labels & Label Reviews
- Ingredient Reviews
- Confirmation of correct International Cosmetic Ingredient Listing
- Cosmetic Notifications
- Medical Device Classification
- High-level Disinfectants and Sterilants
- Contact Lens Disinfectants
- Class I Medical Devices
- Class II Medical Devices
- Food Labeling Review
- Preparation and submission of BCS LONO request
- Food Labeling Compliance and Health Claims
- Nutrition Facts Table (NFTs)
- General consulting on food additives and health and nutrient claims
Drug Product Registration
When a product is offered for sale in Canada to treat or prevent diseases or symptoms, it is regulated as a drug under the Food and Drugs Act (F&DA). Drug products include prescription and non-prescription pharmaceuticals and disinfectants.
There are different types of DIN applications and documentation requirements to file with Health Canada depending on your product. No additional evidence of efficacy is required for submission for Category IV and the labeling standard type of DIN application. New drug applications will require safety and efficacy data.
A “Drug Establishment Licence” is issued to Canadian importers, manufacturers, packagers, and labelers, when they can provide sufficient evidence of procedures or processes that comply with Canadian Good Manufacturing Practices.
A Drug Establishment License (DEL) is a requirement for all Human Use Drug products (DIN) and is approved based on the strength of your Quality Management Systems. Dell Tech understands the complexities of the DEL process and can help you put together your DEL application while providing guidance on the process. From your Foreign manufacturer evidence, your Active Pharmaceutical Ingredients to your on-going stability program requirements, Dell Tech is available to help you navigate the regulations.
Natural Health Product Registration
In order to sell natural health products in Canada, companies must obtain a product license called a Natural Product Number (NPN). To obtain this NPN, detailed information must be provided to, and assessed by, the Natural and Non-Prescription Health Product Directorate (NNHPD).
Once NNHPD has determined that the product is safe, effective, and of high quality, an eight-digit NPN or DIN-HM (Homeopathic Medicine Number) will be granted.
At this time, there is no government fee for obtaining an NPN, and they do not expire. A “Site Licence” is issued to CANADIAN importers, manufacturers, packagers, and labellers when they can provide sufficient evidence of procedures or processes that comply with Canadian Good Manufacturing Practices.
Site Licences are currently renewed annually for the first three years. After that, they are renewed and valid for two years. Once the first seven years have passed, registrations are valid for three years.
While the Natural Health product requires a Product License (NPN), every Manufacturer, Packager, Labeller, Importer and Distributor also require a Canadian Site License. This is based on the strength of your Quality Management System and includes evidence that your Canadian AND Foreign manufacturers are meeting the NHP Good Manufacturing Practices (GMP) requirements. Dell Tech can help you navigate all the licensing requirements and processes, submit your applications and provide guidance on any GMP areas that may need some improvements.
Medical Device Classification
The regulatory submission requirements and manufacturer compliance requirements vary greatly depending on the classification of your medical device. Therefore, it is extremely important to properly classify your product beforehand.
It should be noted that Health Canada’s definitions for medical devices and corresponding device class may not be the same as in other countries. For example, products that are known to be medical devices in the US or EU could be defined as drugs in Canada.
Our experts are qualified in Health Canada regulations and will properly classify your product and associated licensing and compliance requirements from the very beginning. This will help your company avoid unnecessary delays with Canadian regulatory authorities and ultimately save your product’s time to market.
In addition, manufacturers, distributors, and importers of medical devices are required to gain authorization to conduct those activities by obtaining approval through a medical device establishment licence. This review will examine manufacturing practices, records, complaint handling, mandatory reporting, and recall.
The Cosmetic Regulations of the Food and Drugs Act (F&DA) require that cosmetics sold in Canada be manufactured, prepared, preserved, packed, and stored under sanitary conditions. In addition, manufacturers must notify Health Canada that they are selling the product and provide a list of its ingredients. This helps to ensure that cosmetics sold to consumers in Canada are safe to use and do not pose any health risks.
Manufacturers and importers must complete Cosmetic Notification Forms (CNF) to provide specific product information to Health Canada.
Additionally, manufacturers and importers need to ensure that their cosmetic products do not contain ingredients listed on the Cosmetic Ingredient Hotlist, which is comprised of prohibited and restricted substances.
Bureau of Chemical Safety (BCS) Evaluations
Under the authority of the provisions of Section 4(a) of the Food and Drugs Act (F&DA), the Bureau of Chemical Safety (BCS) evaluates the acceptability of various incidental additive products voluntarily submitted by manufacturers wishing to supply their products to food processors.
While not defined under the Food and Drugs Act (F&DA), incidental additives may be regarded, for administrative purposes, as those substances that are used in food processing plants and that may potentially become adventitious residues in foods. They can include products that are regulated as drugs or cosmetics under Food and Drug Regulations (F&DR), but specifically exclude food additives and food packaging materials.
For products considered acceptable by the BCS, No-Objection Letters (LONOs) are issued, which may then be presented by the product manufacturers to prospective food processor customers. A no-objection letter does not constitute an approval of the product under the Food and Drugs Act (F&DA) and Regulations (F&DR), rather it is simply an opinion expressed by the BCS on the acceptability of the product, based on the information available at the time of its evaluation.
Food Safety and Labeling
In Canada, the Food and Drugs Act (F&DA) is the law governing all foods, including meat, fish, processed fruits and vegetables, dairy, and manufactured foods.
Different types of products fall under different levels of government labeling requirements.
- Federal ingredient labeling covers domestic foods, imports, and exports.
- Provincial labeling covers dairy products, alcohol, meat, and environmental packaging.
- Municipal labeling includes in-store bakeries and local manufacturing.
Nutrition Facts Tables (NFTs) are required on most pre-packaged foods in Canada and the US. Some foods may fall under exemptions or prohibitions that allow them to disregard NFTs, but most retailers require NFTs for market.
Canadian NFTs and labels are undergoing changes to provide more transparency regarding added sugars and serving sizes. Sugar-based ingredients will be grouped together instead of being listed separately, and newly-proposed serving sizes will show both the household measure (cups, tablespoons, etc.) and the metric measure (mL, g, etc.). Other proposed changes include increased transparency for allergen information, food additives, and colors.