Disinfectants can be regulated by either Health Canada’s Pest Management Regulatory Agency (PMRA) or Natural Health Products Directorate (NHPD). PMRA is given authority to regulate disinfectants through Pest Control Act (PCA) and Pest Control Products Regulations. NHPD is given authority to regulate disinfectants through the Food and Drugs Act and the ensuring Food and Drugs Regulations.
Antimicrobial products such as sterilants and disinfectants intended for use on environmental surfaces, inanimate objects, and to reprocess medical devices are regulated as drugs under Health Canada’s Food and Drugs Act because they decrease the chance of transmitting disease. NHPD thoroughly reviews these products including their ingredients, uses, and claims before they can be marketed.
Similarly to the United States, Canada also uses monographs to describe the requirements that topical antiseptics and wound cleaners must meet before being offered for sale and use. These products are required to have a Drug Identification Number (DIN) or Natural Product Number (NPN) before entering the marketplace.
TSG can help
- Regulatory product jurisdictional mapping
- Prepare and submit registrations
- Strategy development for addressing data requirements
- Develop and review labels
- Act as a Canadian Agent for foreign companies