Keeping health product safe in Canada
Keeping health products safe means ensuring that the product lifecycle are implemented and in control. The health product lifecycle here refers to all stages in the pre- and post-market “life” of a health product. According to Health Canada, the stages may include several or all of the following: pre-clinical studies, clinical trials, submission of product information to Health Canada for review and evaluation, decision whether to authorize the product for use in Canada, ensuring compliance with manufacturing quality standards, licensing, registration and authorization of those involved in the supply chain (they’re known as establishments), public access to the product, and post-market activities [1].
To keep health products safe, Health Canada conducts a wide range of activities to make sure health products continue to be safe, effective and of high quality. These activities include conducting post-market surveillance, monitoring health product advertising, reviewing literature and new research data for emerging safety information, reviewing reported adverse reactions (side effects), conducting safety assessments and reviewing medical device problems [2]. You can also reduce your risk of adverse effects by telling your doctor what you are taking and why, using products that are approved (look for a DIN, NPN or DIN-HM on the label), being skeptical about health-related claims for potentially serious conditions, being aware of any reaction or interactions with other drugs you are taking, and consulting your health care provider before giving a natural health product to a child [3]. Is there anything else you would like to know?
Keeping health products safe in Canada involves following specific regulations and guidelines set by Health Canada, the country’s federal health department responsible for regulating health products and ensuring their safety. Health products include drugs, medical devices, natural health products, and cosmetics. Here’s how to ensure the safety of health products in Canada:
1. Regulatory Compliance
Understand Regulations: Familiarize yourself with the regulations that apply to your specific type of health product. Different regulations govern drugs, medical devices, natural health products, and cosmetics.
2. Product Authorization
Licensing and Registration: Ensure that your health product is properly authorized by Health Canada before it can be sold. Depending on the category of the product, this might involve obtaining a Drug Identification Number (DIN), a Natural Product Number (NPN), a Medical Device License (MDL), or complying with the Cosmetic Regulations.
3. Quality Control
Good Manufacturing Practices (GMP): Follow GMP guidelines to ensure that your health products are manufactured, packaged, and labeled in a controlled environment that meets high-quality standards.
4. Labeling and Packaging
- Accurate and Clear Labels: Clearly label your health products with accurate and comprehensive information, including ingredients, usage instructions, precautions, and warnings. Labels must be in both English and French.
- Child-Resistant Packaging: Ensure that products with the potential to harm children are packaged in child-resistant containers.
5. Adverse Event Reporting
Report Adverse Events: If any adverse events or unexpected side effects are reported by users, promptly notify Health Canada. This helps in monitoring the safety of your product and taking appropriate actions if needed.
6. Post-Market Surveillance
Monitoring: Continuously monitor the safety and effectiveness of your health product even after it’s on the market. This includes conducting regular safety reviews and addressing any emerging safety concerns.
7. Recalls and Corrective Actions
Recalls: If a safety issue is identified with your health product, cooperate with Health Canada in issuing recalls or other corrective actions to protect the public.
8. Education and Training
Personnel Training: Ensure that your staff is trained on the proper procedures for manufacturing, labeling, and handling health products to minimize errors and ensure safety.
9. Risk Management
Risk Assessment: Conduct thorough risk assessments for your health products to identify potential hazards and implement measures to mitigate them.
10. Regular Updates
Stay Informed: Keep up-to-date with the latest regulations, guidelines, and best practices related to health product safety in Canada. Health Canada’s website and resources are valuable sources of information.
Because the specific steps and requirements can vary depending on the type of health product you are dealing with, it’s important to work closely with Health Canada and seek legal and regulatory advice to ensure full compliance with the applicable regulations.
References
[1] Product Life Cycle – Canada.ca. https://www.canada.ca/en/health-canada/services/science-research/emerging-technology/biotechnology/health-products/product-life-cycle-medicines-health-products-biotechnology.html.
[2] Keeping health products in Canada safe – Canada.ca. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/keeping-health-products-canada-safe.html.
[3] Health Insurance Product Development & Management [5 Stages]. https://global.hitachi-solutions.com/blog/health-insurance-product-development/.
About the author: Kossi Molley, PMP., LSSBB., Chemist