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REGULATORY CATEGORIES
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Our consultants have expertise in different regulatory fields related to the drug, NHP, dietary supplement, cosmetic, and medical device industries. Review the definitions below to determine which category your product falls under. If you're still not sure which category your product belongs in, we can help you determine whether your product is a drug, cosmetic, NHP, dietary supplement or medical device quickly and easily.
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Drug Products
Drug products include prescription and non-prescription pharmaceuticals,
disinfectants and sanitizers with disinfectant claims.
Health Canada defines a drug as "any substance or mixture of substances
manufactured, sold, or represented for use in (a) the diagnosis, treatment,
mitigation, or prevention of a disease, a disorder, or abnormal physical state, or
its symptoms in human beings or animals, (b) restoring, correcting or modifying
organic functions in human beings or animals, or (c) disinfection in premises in
which food is manufactured, prepared, or kept." [Food & Drugs Act].
If your product is a drug, see Drugs on the Q&C® website for more information.
Natural Health Products
Natural health products are classified as:
- Vitamins and minerals (including many formulations for sunscreens and
antiperspirants)
- Herbal remedies (including many formulations for anti-acne products)
- Homeopathic medicines
- Traditional medicines such as traditional Chinese medicines
- Probiotics
- Other products like amino acids and essential fatty acids.
Health Canada defines a natural health product (NHP) as "a substance set
out in Schedule 1 of the Natural Health Products Regulations or a combination of
substances in which all the medicinal ingredients are substances set out in
Schedule 1, a homeopathic medicine or a traditional medicine that is
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 humans;
- Restoring or correcting organic functions in humans; or
- Modifying organic functions in humans, such as modifying those functions in a
manner that maintains or promotes health."
An NHP does not include a substance set out in Schedule 2 of the Natural Health
Products Regulations or any combination of substances that includes a substance
set out in Schedule 2. [NHP Regulations].
NHPs must be safe for consideration as over-the-counter products, be available
for self-care and self-selection and not require a prescription to be sold.
If your product is a natural health product, see NHP Regulatory for more
information on the services we offer.
Cosmetics
Cosmetics are best defined by what they are not. They are not:
- Products that have a therapeutic claim or that contain certain ingredients not
permitted in cosmetics, for example sunscreens - these are drugs
- Products containing natural therapeutic ingredients, for example many
toothpastes - these are considered natural health products (NHPs)
- Items where ingestion is intentional and that do not have a therapeutic effect
or claim - these are food products
- Insect repellent lotions and sprays - these are pesticides
- Products (such as creams, lotions, or shampoos) providing a therapeutic
benefit to animals - these are veterinary drugs.
Each of these categories are regulated under the Food and Drugs Act,
which
defines cosmetics as "any substance or mixture of substances manufactured,
sold, or represented for use in cleansing, improving or altering the complexion,
skin, hair or teeth, and includes deodorants and perfumes."
If your product is a cosmetic, see Cosmetics on the Q&C® website for more information.
Medical Devices
A medical device is “any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other
similar or related article, intended by the manufacturer to be used alone or in
combination, for human beings for one or more of the specific purpose(s) of:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease,
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- Investigation, replacement, modification, or support of the anatomy or of a
physiological process,
- Supporting or sustaining life,
- Control of conception,
- Disinfection of medical devices,
- Providing information for medical purposes by means of in vitro examination
of specimens derived from the human body.
And which does not achieve its primary intended action in or on the human body
by pharmalogical, immunological or metabolic means, but which may be assisted
in its function by such means.”
[Definition from ISO 13485:2003]
If your product is a medical device, see Drugs on the Q&C® website for more information on
the services we offer.
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