Authorization of Hand Sanitizers and Surface Disinfectants in Canada
Depending on the product’s intended use, ingredients, and claims, the finished product may be classified as either a natural health product (NHP), non-prescription drug, or pesticide and require pre-market approval prior to importing and marketing these products in Canada.
Hand Sanitizers
Alcohol-based hand sanitizers intended for personal-use are classified as NHPs and must obtain a Natural Product Number (NPN) from the Natural and Non-prescription Health Products Directorate (NNHPD) as per the requirements listed within the Natural Health Product Regulations.
Products that do not contain naturally-based ingredients, utilize product claims outside of the requirements of the Antiseptic Skin Cleaners monograph, or are intended to be used in commercial or institutional settings (i.e., hospitals, workplaces, stores, public washrooms, etc.) are defined as non-prescription Antiseptic Drugs and must obtain a Drug Identification Number (DIN) in accordance with the Food & Drug Regulations.
All facilities involved in manufacturing, packaging, labelling, or importing NHPs or non-prescription drugs are required to conform to good manufacturing practices (GMPs). In order to attest to the established GMPs, the following must be obtained prior to placing hand sanitizers on the market:
- A site license (SL) for NHPs
- A drug establishment license (DEL) for drugs
Our scientific and regulatory experts can help with obtaining market authorization of hand sanitizers in Canada. Our services include:
- Product review and classification (NHP or antiseptic drug)
- Preparation of Product License Applications (PLAs)
- Preparation of dossiers to support the safety, efficacy and quality of products outside monograph conditions
- Labelling and claim review of NHPs and DINs
- Preparation of SL or DEL applications
- Creation of testing strategies and/or risk assessments for products outside monograph conditions
- Application stewardship and consultation with the NNHPD regarding authorization strategies, submitted applications, etc.
In Canada surface disinfectants and sanitizers can fall under two Acts:
1. Food and Drugs Act
- Regulated by the Natural and Non-prescription Health Products Directorate (NNHPD)
- “disinfection” claims for hard surfaces, non-porous environmental surfaces and inanimate objects are regulated by Health Canada as disinfectant drugs
- Disinfectant drugs require a pre-market assessment and issuance of a DIN prior to being sold in Canada
- “disinfection” claims for hard surfaces, non-porous environmental surfaces and inanimate objects are regulated by Health Canada as disinfectant drugs
2. Pest Control Products Act (PCPA)
- Regulated by the Pest Management Regulatory Agency (PMRA)
- “sanitization” claims and other “kill” claims related to microbes are regulated as pesticides
- Pesticide registration requires the submission of efficacy data, physical/chemical product data, and toxicological data to support safet
- “sanitization” claims and other “kill” claims related to microbes are regulated as pesticides
To have both “disinfection” and “sanitization” claims appear on a product label, approval must be granted separately from the NNHPD and the PMRA.
How can Intertek Help?
- Identification of appropriate regulatory route for disinfectant products based on efficacy claims and ingredients
- Preparation and submission of the regulatory application (DIN application for a disinfectant drug product, or PMRA application for products considered an antimicrobial pesticide)
- Product label review against the applicable regulation(s)
- Act as a liaison between Health Canada and our clients during the application review
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