Drug Identification Number (DIN)
Registration Services
Navigating Health Canada’s regulatory landscape for Drug Identification Number (DIN) registration is essential for companies aiming to market drug products, including sunscreens and disinfectants, in Canada. A DIN is a unique eight-digit number assigned to each drug product authorized for sale in Canada, signifying that the product has undergone evaluation and meets the necessary safety, efficacy, and quality standards
GOVERNMENT OF CANADA
DIN or NPN Guidance
According to Health Canada’s regulations, Drug Identification Number (DIN) is needed for drug products and a Natural Product Number (NPN) is needed for natural health products. Nexreg can provide registration services on both for products including (but not limited to):
Understanding DIN Registration
To register a Drug Identification Number (DIN) with Health Canada, manufacturers must submit the following key information:
- Product Details: Name, active/inactive ingredients, pharmaceutical form, and route of administration.
- Manufacturer Information: Company name, address, Canadian importer (if applicable), and contact details.
- Product Testing: Stability data, analytical test results, and any clinical evidence supporting safety and efficacy.
- Labeling & Packaging: Draft labels, bilingual content, and packaging compliant with Health Canada regulations.
- Risk & Safety Data: Known adverse reactions and risk mitigation strategies.
- Good Manufacturing Practices (GMP): Proof of GMP compliance and third-party certifications.
- Application Forms & Fees: Completed DIN application form and proof of fee payment.
- Additional Documentation: Product monograph, marketing materials (if applicable), and prior market authorizations.
Having these documents prepared ensures that Nexreg can effectively provide compliance guidance and that Health Canada can efficiently review your application. Nexreg specializes in guiding manufacturers through this process for seamless compliance.
Notice of Compliance (NOC) and Market Notification
In addition to obtaining a DIN, certain products may require a Notice of Compliance (NOC), which confirms that the product complies with the Food and Drugs Act and its regulations. Once a DIN and, if necessary, an NOC are secured, manufacturers must notify Health Canada within 30 days of commencing sales. This market notification is crucial for maintaining compliance and ensuring that Health Canada’s records are up to date
GOVERNMENT OF CANADA
Nexreg’s Expertise in Canadian Regulatory Compliance
At Nexreg, we specialize in guiding companies through the complexities of Canadian regulatory compliance for drug products. Our services include:
- DIN Registration Consulting:
Assisting with the preparation and submission of DIN applications to Health Canada, ensuring all regulatory requirements are met.
- Label Review Service:
Providing guidance on labeling requirements and ensure compliance with the applicable Health Canada Monograph.
- Market Notification Support:
Managing the necessary notifications to Health Canada upon the first sale of DIN-registered products.
With our expertise, companies can confidently bring products like sunscreens and disinfectants to the Canadian market, ensuring full compliance with Health Canada’s regulations.
Why Choose Nexreg?
Partnering with Nexreg offers
Our team has provided over 20 years of Health Canada’s chemical regulatory guidance. We continue to stay updated on global regulatory advancements to offer guaranteed compliance for every project.
In-Depth Regulatory Knowledge
Our team has provided Health Canada compliance consultations for 20 years, enabling thousands of companies to sell their products within the Canadian market. We continually stay current with Health Canada’s regulatory updates, providing accurate and timely guidance.
Tailored Compliance Strategies
We develop customized plans that align with your specific product needs and business goals.
Comprehensive Support: From initial application to post-market compliance, we offer end-to-end assistance to streamline the regulatory process.
Ensuring compliance with Health Canada’s DIN requirements is vital for the successful marketing of drug products in Canada. Nexreg is committed to providing the expertise and support needed to navigate this regulatory environment effectively.