CANADA

Bonjour! Although Canada borders the US, there are some unique requirements not typically seen in the rest of North America.
Canada is a bilingual country, so French is as important as English if you plan to market here.
We offer the following regulatory services for Canada:

• Cosmetic Notification
  • Each product formula and product name must be notified to Health Canada
  • Ingredient and label review available to avoid Canadian government enforcement
• Labelling Compliance
• Ingredient Compliance
• Good Manufacturing Practices (GMPs) ISO 22716
• DIN/NHP Application and Label / Claim Review
  • Drug Information Number (DIN) application
  • Natural Health Product (NHP) applications
    • DIN and NHP registrations are used for drug products issued from Health Canada.
    • Review of product for proper classification for DIN or NHP will be
      provided
    • Approval for these two categories is required before product is allowed
      to be sold in Canada.
    • Label review will be part of the application requirements

Cosmetic Notifications

Did you know that Canada has registration requirements for all cosmetics? You will need to prepare your product for ingredient and labeling compliance first. This will ensure your product classification fits cosmetic requirements. These notifications are actively reviewed and can take several months to clear Health Canada.

Labelling & Claims Compliance

Product can be stopped at Canadian Customs at any point of entry. Don’t take the risk. No one wants the disruption in their supply chain or damage to their brand.

Taking a risk on how a product is labeled by not having a professional review or choosing to risk not following recommendations of regulatory professionals will ultimately result in enforcement from Health Canada. The label and what is written about your product is the first glimpse by Health Canada for compliance.

Many companies join US labelling with Canadian labeling to meet the criteria for both countries. However, interpretation of claims can differ and so can enforcement. We can show you how to have acceptable dual labelling, avoiding enforcement in both countries.

Depending on what you say about your product(s), how you say it and/or how the consumer perceives the effects that are promised, can have a negative impact from the Health Canada viewpoint. What may be presented as a cosmetic may be reviewed by Health Canada as a drug or natural health product. That triggers many different requirements.

While International Nomenclature for Cosmetic Ingredients (INCI) are recognized worldwide, Canada has some unique trivial INCI that must be used to clear Customs.

Potential Areas of Enforcement:

• Labelling Format
• Ingredients (don’t assume your ingredients are legal!)
• Claims
• Product Classification
• Consumer Perspective

Good Manufacturing Practices (GMPs)

ISO 22716 GMP (Cosmetic)

Since the issuance of the International Standards Organization (ISO) Cosmetics GMP 22716, Health Canada recognizes this standard as a requirement for cosmetic products offered for sale.

As Designated Experts, International Cosmetics participated in the creation and development of ISO 22716 and continues to be involved with updates and the ISO proceedings internationally.

Our services include:

• Training
• Certification
• Auditing

GMP Audit

Since 1997, we have been providing GMP audit services both domestically and internationally. With our many years of experience,

we bring practical in-depth knowledge of manufacturing processes. We have performed audits in domestic and international facilities, such as Germany,Switzerland,  Poland, the UK, Mexico, Japan, China, and others.

All licensed establishments must follow Canadian GMP requirements to ensure your productsstay on the shelf and are Health Canada compliant.

We offer:

• ISO 22716 Cosmetic GMP Audits
• GMP Audits for Drug Compliance
• Audits for Natural Health Products Compliance

When Health Canada comes knocking at your door, will you be ready?

GMP Training

cGMP (Current Good Manufacturing Practices) training is required to comply with these regulations. Regulations are only part

of the requirement. As experienced Auditors, we provide mandatory training to meet GMP criteria for your participating staff

members. These individuals must stay current with ongoing training and keep records accordingly. We provide off-site classes custom tailored to your needs.

Registrations for Drug Identification Numbers (DINs)

When the product classification fits a drug definition, here is what you can expect. Before you can register with Health Canada, you will need an expert to guide you with tests and data for the submission. Manufacturers must meet Health Canada criteria and be registered with payment of corresponding fees. This applies to both Drugs and Natural Health Products (NHPs). This is a formal registration and the product cannot be marketed until it is approved by Health Canada.