In Canada, cosmetics are classified as Cosmetic, OTC (Non-Prescription Drug), or Natural Health Product, regulated according to the Food and Drugs Act (FDA) and require a registration with Health Canada. EcoMundo takes care of every step of your compliance in Canada.

 
1

PRELIMINARY STUDY

EcoMundo can assist you in classifying your product(s). Health Canada classifies products that fall on the cosmetic-drug interface based on:

  • Representation : The product is represented as serving a cosmetic function, such as moisturizing or cleansing, or a therapeutic function, such as treatment of a disease.
  • Composition of the product : The presence of an ingredient, or its concentration, may result in a product being unsuitable to be classified as a cosmetic.
  • Level of action : Cosmetic effects are generally achieved by applying a product to an external part of the body, without absorption below the skin.

EcoMundo provides strategic consultancy on how to classify your product  in Canada: Cosmetic, Natural Health Product or OTC.

2

COSMETICS

The Cosmetic Regulations within the Canadian Food and Drugs Act regulate the compliance of cosmetic products based on the product itself, its ingredients, its claims, and its labelling.

Manufacturers and importers must notify Health Canada within the 10 days of selling a cosmetic in Canada. This notification is submitted through the Cosmetic Notification Form (CNF).

EcoMundo provides complete regulatory support to notify your cosmetic products and comply with Canadian FDA.

3

OTC

EcoMundo can assist you in navigating the Health Canada OTC Monographs specific to your product. These monographs provide direction on the permissible conditions of use and labelling requirements, including dose, intended use, directions for use, warnings, and active ingredients.

Whether your product is a Natural Health Product or a Non-Prescription Drug (OTC), all firms looking to manufacture, package, label or import natural health products or drugs into Canada must have a site licence. Establishments working with Non-Prescription Drugs must have a Drug Establishment License (DEL). While establishments working with Natural Health Products must have an NHP Site License. EcoMundo can assist you in obtaining your Drug Establishment License (DEL) or your NHP Site License.

Finally, EcoMundo can assist you in registering your product and obtaining your Natural Product Number (NPN) for your natural health product or your Drug Identifcation Number (DIN) for your non-prescription drug.

EcoMundo takes care of all the steps of the registration of your OTC products with the Canadian FDA.