Canada has a well-established regulatory framework for Natural Health Products (NHPs), with Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) overseeing product licensing, site licensing and Good Manufacturing Practices (GMP).
For companies looking to take Canadian NHPs into international markets, this regulatory approval can be a significant advantage, and Dell Tech Laboratories Ltd. can help you put it to work.
Supporting Canadian NHPs in Global Markets
Dell Tech is authorized under Health Canada’s NNHPD Third-Party Issuance Program to issue International Trade Certificates (ITCs) and GMP Certificates for eligible natural health products and sites.
These certificates provide regulatory documentation that foreign authorities, importers or distributors may request as part of an international market entry or product registration process. In other words: when your NHP needs documentation to support its journey into a new market, Dell Tech can help.
International Trade Certificates (ITCs)
An International Trade Certificate provides information about the regulatory status of an NHP in Canada and the Canadian site involved in its manufacture, packaging or labelling. Health Canada describes ITCs as a mechanism intended to help facilitate the export of Canadian NHPs to foreign markets.
For companies exporting NHPs, an ITC can help demonstrate to international regulatory authorities and business partners that the product has a recognized regulatory status in Canada. They are particularly valuable when a foreign market requires evidence of Canadian licensing or regulatory oversight as part of its importation or registration requirements.
GMP Certificates: Demonstrating Quality and Compliance
Good Manufacturing Practices are a fundamental part of Canada’s NHP regulatory framework. Health Canada’s GMP requirements apply to activities including the manufacture, packaging, labelling, importing, distributing, storing and testing of NHPs. The current GMP guidance provides a comprehensive framework for quality systems and GMP compliance.
A GMP Certificate provides international regulators and business partners with documented evidence of a site’s GMP compliance. For companies entering markets where proof of GMP compliance is required, having the appropriate certification readily available can help support the regulatory process and reduce potential barriers to market access.
Why Canadian Regulatory Status Is an Advantage
Canada’s NHP regulatory system provides a strong foundation for companies seeking to build credibility internationally. A Canadian product licence, site licence and GMP compliance demonstrate that a product and its associated activities are subject to established regulatory requirements for quality and safety.
Health Canada’s framework is also recognized in international regulatory relationships; for example, Health Canada has been a member of the PIC/S since 1999, an international framework that supports mutual confidence in GMP inspections among participating regulatory authorities. Arrangements like this mean GMP compliance can be recognized or used as evidence of compliance for certain products and facilities in other jurisdictions.
Maintaining a strong regulatory foundation at home can help create a smoother path to expansion abroad.
How Dell Tech Can Help
Whether you’re entering a new international market, responding to a foreign regulator’s request, or preparing documentation for an international distributor, obtaining the right certificates can be an important step in the process.
Our regulatory expertise doesn’t stop at Canadian compliance, our team can support you with the documentation needed to take your products beyond Canada’s borders, including:
- International Trade Certificates (ITCs)
- GMP Certificates
With decades of experience in NHP regulatory affairs, Dell Tech understands both the Canadian regulatory landscape and the documentation challenges that arise when taking products into international markets.
If you require an International Trade Certificate or GMP Certificate for an export or international registration, contact the Dell Tech regulatory team today to discuss your requirements.
Blog Author
Jackie Menzies Yarnton
Jackie Menzies Yarnton is a Principal Regulatory Consultant with over 15 years of experience in natural health products, cosmetics, and food regulations in Canada. She is actively involved in advancing regulatory standards through her work with industry organizations.
