Disinfectants and sanitizers compliance – 加拿大
Disinfectants can be regulated by either Health 加拿大’s Pest Management Regulatory Agency (PMRA) 或者是 Natural and Non-prescription Health Products Directorate (NNHPD),以前 Natural Health Products Directorate (NHPD). PMRA is given authority to regulate disinfectants through the Pest Control Act (PCA) and the Pest Control Products 监管s. NNHPD is given authority to regulate disinfectants through the Food and Drugs Act and the ensuring Food and Drugs 监管s.
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 加拿大’s Food and Drugs Act because they decrease the chance of transmitting disease. NNHPD thoroughly reviews these products including their ingredients, 使用, and claims before they can be 市场ed.
与美国类似, 加拿大 also 使用 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 市场place.
- Regulatory product jurisdictional mapping
- Strategy development for addressing data requirements
AG8大厅登录 provides 公司 with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. AG8大厅登录's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect f或者是 confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
AG8大厅登录’s team specializes in assisting 公司 to prepare and submit registrations for sterilants and disinfectants, as well as supporting clients with label compliance.
Disinfectants and sanitizers help combat the spread of germs in the home, 餐厅, hospitals and other industrial and public health settings. Disinfectants destroy microorganisms on surfaces while sanitizers significantly reduce the level of microorganisms to acceptable levels established by federal or provincial authorities.
Non-food contact surface sanitizers, 柔软的表面消毒液, greenhouse disinfectants and swimming pool and spa disinfectants are regulated under the Pest Control Products Act and Pest Control 监管s.
The following disinfectants / sanitizers are regulated by the Food and Drugs Act and the Food and Drug 监管s: hard surface disinfectants for use in food processing facilities, hard surface disinfectants for use in federally registered food establishments, food contact surface sanitizers and sanitizers for use in federally registered food establishments. Antimicrobial products such as sterilants and disinfectants intended for use on environmental surfaces, inanimate objects and to reprocess medical devices are also regulated under the Act.
酒精洗手液, 例如酒精洗手液, gels or rinse sanitizers are disinfectants containing at least 60% alcohol. They are regulated under the Food and Drugs Act and 监管s. AG8大厅登录’s experts can advise on data requirements, as well as help prepare and submit product registrations.
A药品识别编号, 也被称为DIN, is an eight-digit computer-generated number that uniquely identifies a product’s manufacturer, 的名字, 活性成分(s), strength(s) of 活性成分(s), pharmaceutical form and route of administration. Health 加拿大 issues a DIN to all authorized prescription and over-the-counter drugs in 加拿大, permitting the manufacturer to 市场 the drug in 加拿大. The DIN number is included on the product’s label. AG8大厅登录’s regulatory experts can assist in preparing the information and filing the DIN application to Health 加拿大.