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Product categories

The limit between the different categories of products is often blurred. Here are some examples:

  • Products that have a therapeutic claim or that contain certain ingredients not permitted are considered to be drugs, for example sunscreens.
  • Products containing natural therapeutic ingredients are considered natural health products, for example many toothpastes.
  • Items where ingestion is intentional and that do not have a therapeutic effect or claim are food products.
  • Insect repellent lotions and sprays are pesticides.
  • Products (such as creams, lotions, or shampoos) providing a therapeutic benefit to animals are veterinary drugs.

Many products can be «hybrids», containing one or many natural health and/or drug and/or food and/or cosmetic ingredients. A hybrid product may be subject to one or more of the Natural Health Products Regulations, Food and Drug Regulations, Cosmetics Regulations, or Medical Devices Regulations, depending on the ingredients, representation for use (primary purpose) and health claims of that product. The hybrid products, given their complexity and diversity of ingredients, are assessed differently from product categories listed below and analyzed on a case by case basis by Health Canada.

What is a Natural Health Product?

The NHP definition has two components: function and substance. The function component refers to the natural health product definition capturing those substances that are manufactured, sold or represented for use in:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
  2. restoring or correcting organic functions in humans;
  3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

The substance component refers to the medicinal ingredient in a natural health product.
Under the Natural Health Products Regulations, which came into effect on January 1, 2004, natural health products (NHPs) are defined as:

  • Vitamins and minerals
  • Herbal remedies
  • Homeopathic medicines
  • Traditional medicines such as traditional Chinese medicines
  • Probiotics
  • Other products like amino acids and essential fatty acids
How are they regulated in Canada ?

All the natural health products (NHPs) marketed in Canada fall under Food and Drugs Act. The Natural Health Products Regulations require individuals to obtain a product licence before they can sell a natural health product (NHP) in Canada. To obtain a product licence, individuals must submit a product licence application to the Natural Health Products Directorate (NHPD). The application must include sufficient data to allow NHPD to evaluate the safety, quality and efficacy of the NHP when used according to the recommended conditions of use. Drug-natural health product combinations are always regulated as drugs.

Who is affected by this regulation?
  • Manufacturers
  • Packers
  • Labellers
  • Importers
  • Distributors
And if I don’t comply with this regulation ?

Health Canada may at any time inspect a site, and suspend or cancel a product or site licence when there are reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a purchaser or consumer of a natural health product. Moreover, Health Canada shall suspend the marketing or importation authorization of a natural health product, and to require the manufacturer/distributor to recall the product.
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What is a cosmetic?

The law defines a cosmetic as a product which cleanses, improves or alters the complexion, skin, hair or teeth. A beauty product or grooming aid is usually categorized as a cosmetic, but will be legally classified as a drug if it makes any claims to modify body functions, to prevent or treat disease.
Here are one example :

  • A deodorant is a cosmetic because they stop the smell of perspiration.
  • An antiperspirant is a drug because it removes perspiration.
How are they regulated in Canada ?

On 1 December 2004, Health Canada pubished the new Regulations on cosmetics. This new regulation requires the listing of ingredients on the label for all cosmetic products sold in Canada. This measure, along with other changes made on the cosmetic regulations, strengthens the protection of health and safety of the Canadian public regarding the use of cosmetics. This change entered into force on November 16, 2006. This means that companies selling cosmetics in Canada must comply with the new requirements.

Who is affected by this regulation?

The manufacturer must submit to Health Canada a Declaration of cosmetics, together with information regarding labeling and safety. The ingredients must be listed according to the INCI nomenclature. Health Canada is reviewing the ingredients to determine if they meet the requirements.

And if I don’t comply with this regulation ?

Only ingredients that do not pose an unreasonable health and safety risk to the Canadian public, when used according to directions, are allowed in cosmetic products. Where a cosmetic product may pose a risk to health: The Company may be required to provide additional information; tests can be performed on the product; a risk assessment can be undertaken.

The various corrective actions are:
  • The reformulation of the product or ask a new label on it;
  • withdraw the product from the market / voluntary recall;
  • importation refusal;
  • seizure and disposal;
  • issue a public notice.

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What is a food?

A food is any article manufactured, sold or presented like which can be used as food or drink for human being, the chewing gum as any ingredient which can be mixed with a food at some end that it is.

How are they regulated in Canada ?

In Canada, the labelling of food is mainly regulated by the Food and Drug Act and the Consumer Packaging and Labelling Act, managed by the Ministry for Justice and applied by the Canadian Food Inspection Agency. Other laws can “be grafted” on food labelling depend on the category of food.

Food and drug regulations envisages the labelling of all food pre-packaged, including the requirements relating to the list of the ingredients on the label with the nutritional labelling, with the deadlines of conservation, the allegations relating to the nutritive content, the allegations relating to health and food intended for the consumers having special food modes. The regulation also establishes requirements as regards bilingual labelling.

Who is affected by this regulation?
  • Manufacturers
  • Distributors
And if I don’t comply with this regulation ?

Whoever contravening the Food and Drug Regulations and/or the Consumer Packaging and Labelling Act is liable to a fine being able to go from 1000 to 250,000$ as well as the imprisonment.
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What is a medicinal product (drug)?

A medicinal product is any substance or mixture of substances manufactured, sold or represented for use in:

  • the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
  • restoring, correcting or modifying organic functions in human beings or animals,
  • disinfection in premises in which food is manufactured, prepared or kept”

Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.

How are they regulated in Canada ?

Health Canada’s Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product’s safety, efficacy and quality as required by the Food and Drugs Act and Regulations. To be done, a manufacturer must present substantive scientific evidence of a product’s safety, efficacy and quality as required by the Food and Drugs Act and Regulations.

Therefore, to sell a drug in Canada, the manufacturer must have a drug identification number (DIN) and a licence of establishment. The manufacturers, packers, labellers, importers, distributors must follow the Canadian Good manufacturing Practices.

Who is affected by this regulation?
  • Manufacturers
  • Packers
  • Labellers
  • Importers
  • Distributor
And if I don’t comply with this regulation ?

Health Canada may at any time inspect a site, and suspend or cancel a product or site licence when there are reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a purchaser or consumer of a natural health product. Health Canada may suspend the authorization to sell or import a drug at any time and require the owner of the DIN to recall the product.

What can we do for you?

We can assist you in your steps with the TPD for the request of a DIN, the request for a licence of establishment, their modification or renewal.
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What is Control and Quality assurance?

Every manufacturer must have a control and quality assurance system to conform to the Canadian Good Manufacturing Practices (GMP).

Quality assurance is a wide-ranging concept that covers all matters that individually or collectively influence the quality of a drug. It is the total of the organized arrangements made with the objective of ensuring that drugs are of the quality required for their intended use. Quality assurance therefore incorporates Good Manufacturing Practices, along with other factors that are outside the scope of these guidelines.

A system of quality assurance appropriate for the manufacture of drugs should ensure that:

  • Drugs are designed and developed in a way that takes into account the GMP requirements;
  • Managerial responsibilities are clearly specified;
  • Systems, facilities and procedures are adequate;
  • Production and control operations are clearly specified, and GMP are adopted;
  • Arrangements are made for the supply and use of the correct raw and packaging materials;
  • Control on intermediates, in-process monitoring, and validation activities are carried out;
  • The finished product is processed, packaged/labelled, verified, and tested according to defined procedures;
  • Drugs are not sold or supplied before the quality control department has indicated that each batch has been produced and controlled in accordance with the requirements of the marketing authorization and of any other regulations relevant to the production, control and release of drugs;
  • Satisfactory arrangements exist for ensuring that the drugs are stored, distributed, and subsequently handled in such a way that quality is maintained throughout their shelf life;
  • There is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system;
    How are they regulated in Canada ?

    Title 1A, Part C of the Food and Drug Regulations defines the activities for which compliance with good manufacturing practices must be demonstrated before a site licence is granted.

    Who is aimed by this regulation?
    • Manufacturers
    • Packers
    • Labellers
    • Importers
    • Distributors
    And if I don’t comply with this regulation ?

    Any drug must be manufactured in accordance with the Canadian GMPs under a valid site licence. If Health Canada have reasonable reasons to believe that a drug was manufactured under conditions which does not conform to the GMPs, it can requires with the manufacturer to withdraw the product of the market and also, in some cases, to suspend the site licence to the manufacturer.

    What can we do for you?

    Our team of experts can assist you to build a control and quality assurance system which conforms to the Canadian GMPs.
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