Classifying Your Self Care Product in Canada
By: Jacqui Jenskey, Principal Regulatory Affairs Consultant, email
Bringing a cosmetic, drug, or natural health product to market in Canada requires a classification assessment and completion of a cosmetic notification or a product registration for a DIN for drugs, or an NPN for natural health products.
What is a Cosmetic?
As per the Food and Drugs Act, a cosmetic is any substance or mixture of substances, manufactured, sold, or represented for use in cleansing, improving, or altering the complexion, skin, hair, or teeth. This includes deodorants and perfumes. Other products include hair and body shampoo, soaps, lotions, and creams that make claims such as cleaning, improving the appearance of, and/or soothing dry skin, etc.
What is a Drug?
As per the Food and Drugs Act(Act), a drug is defined as a product that is offered for sale in Canada to treat or prevent diseases or symptoms. All drugs require registration for a DIN. DIN, stands for Drug Identification Number and is a computer-generated 8-digit number assigned by Health Canada to a drug product (prescription, disinfectants, and over-the-counter drugs) prior to being marketed in Canada. The DIN is a unique number and identifies the drug’s characteristics such as the manufacturer, product name, active ingredient(s), strength(s) of active ingredient(s), pharmaceutical form, and route of administration.
The issuance of a DIN permits the manufacturer to market the drug in Canada. It also indicates that the product has undergone and passed a review of its formulation, labeling, and instructions for use. A drug product sold in Canada without a DIN is not in compliance with the law.
What are Natural Health Products?
Natural Health Products are defined as vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines (like Traditional Chinese Medicines), probiotics, and other products like amino acids and essential fatty acids. A natural health product must be safe, be an over-the-counter product (available for self-care and self-selection) and not require a prescription to be sold. All natural health products require registration for a NPN. NPN stands for Natural Product Number and is an eight-digit number assigned to each natural health product approved to be marketed under the Natural Health Products Regulations.
Similar to the requirements for drugs. All natural health products are required to submit an online Product Licence Application (ePLA) prior to being marketed in Canada. The ePLAs will be screened against regulatory requirements as outlined in the regulations and guidance documents for safety, efficacy, and quality. A Product Licence will be issued for applications satisfying the regulatory requirements. The Product Licence will include the NPN assigned to the product. In Canada, no person shall sell a natural health product unless a product license is issued for the natural health product.
How do you determine your product classification?
Each product needs a formula and label claim review to help determine the classification and potential options available to you. Let’s consider the Canadian classification system of Sunscreens. A sunscreen with no SPF/sunscreen claims is a cosmetic, even if that ingredient is present in the formula. If that sunscreen makes a SPF/Sunscreen claim on the label and the active ingredient is a synthetic active (Octinozinate) then your Sunscreen must be registered as a Drug. If the active ingredient is natural (Titanium Dioxide or Zinc Oxide) then your SPF/Sunscreen product must be registered as a Natural Health product.
Dell Tech can take the complications out of your classification and can assess your formula and claims to determine the correct regulatory path for your product. Contact Jacqui Jenskey at firstname.lastname@example.org or Kim Samela at email@example.com for more information.
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