Getting to grips with good practice for exports

Natural Health products (NHPs) in Canada include products such as vitamins and minerals, herbal remedies and homeopathic medicines, and other products classified as NHPs based on their ingredients and claims.

Alongside these, nicotine-containing products continue to sit within a more complex regulatory landscape. In Canada, therapeutic nicotine products authorised for smoking cessation are regulated as drugs (NRTs). Depending on dosage form and nicotine content, NRTs may be authorised either as a natural health product or as a prescription drug.

What has not changed is that the regulatory foundation remains the same. Although Version 4.0 introduces clearer and more detailed expectations, the underlying legal framework for natural health product GMP has not changed. 

GMP requirements for NHPs remain rooted in Part 3 of the Natural Health Products Regulations. These regulations continue to set out the core obligations relating to specifications, premises, equipment, personnel, sanitation, operations, quality assurance, stability and record-keeping. Companies involved in manufacturing, packaging, labelling or importing NHPs must still operate within a site-licensed framework supported by documented procedures and effective quality oversight across the product lifecycle. 

The update is not about rewriting the rulebook, but about demonstrating that established GMP principles are embedded in day-to-day operations and supported

In that sense, Version 4.0 does not introduce a new compliance regime. There are no new statutory GMP requirements. Instead, Health Canada has clarified how existing regulatory expectations should be interpreted, implemented and evidenced during inspection.

For many organisations, this distinction is important. The update is not about rewriting the rulebook, but about demonstrating that established GMP principles are embedded in day-to-day operations and supported by mature, functioning quality systems.

Clearer expectations and a stronger inspection lens

While the legal framework remains unchanged, Version 4.0 is more detailed and more explicit in how compliance should be demonstrated in practice. The shift is less about new rules and more about clearer expectations, and a stronger inspection lens on how GMP systems function day to day.

The updated guide places increased focus on the effectiveness of company-wide quality systems. Governance, accountability and documented oversight by senior management are more clearly articulated. Health Canada is signalling that quality assurance must be an active, embedded function rather than a procedural formality.

Inspectors are likely to look beyond the existence of SOPs and assess whether quality systems are implemented, monitored and capable of driving continual improvement.

The shift is less about new rules and more about clearer expectations

Although stability has always been a GMP requirement, Version 4.0 provides significantly greater clarity on what constitutes an acceptable stability programme. Expectations around protocol design, ongoing studies, trending, reporting and scientific justification of shelf life are more explicit.

For some organisations, this may require revisiting stability strategies to ensure they are risk-based, scientifically defensible and inspection-ready. Shelf-life rationale and storage condition justification should be supported by robust data rather than historic precedent.

The guidance expands on how companies should manage deviations, investigations, out-of-specification results and corrective and preventive actions (CAPA). There is a clear expectation that systems are not only documented but demonstrably effective.

Recall systems, including mock recalls, are also addressed with greater clarity. Health Canada is reinforcing that traceability and responsiveness are critical components of GMP compliance, particularly in a market where product categories can span both NHP and prescription classifications.

Version 4.0 provides enhanced direction on documentation practices, including electronic records and electronic signatures. Greater attention is given to traceability, data integrity and the availability of GMP evidence during inspection.

Companies using electronic quality management or laboratory systems should ensure controls, access management and audit trails are clearly defined and defensible.

While importer obligations already exist in Part 3 of the Regulations, Version 4.0 is more explicit about the evidence importers should maintain, including quality agreements and batch documentation review. This includes supplier qualification, quality agreements, review of batch documentation and documented release decision-making within the quality system.

Using the transition period effectively

Organisations will need to validate their GMP systems to meet the clarified expectations of Version 4.0. Stability programmes, CAPA effectiveness, data integrity controls and importer oversight should be demonstrably inspection-ready. Addressing gaps now enables structured improvement and minimises the risk of findings, supply delays or reputational impact once the updated guide becomes the primary inspection reference.

Broughton can support companies in translating Health Canada’s updated GMP expectations into practical, inspection-ready solutions. This includes GMP gap assessments against Version 4.0, stability strategy development and execution, batch and lot testing, and the creation of robust documentation packages that stand up to regulatory scrutiny.

As an MHRA-inspected GMP and UKAS-ISO17025 certified testing laboratory and consultancy, Broughton brings experience across pharmaceuticals, reduced risk nicotine products, medicinal cannabis and other regulated health products. By combining scientific testing with regulatory insight, Broughton helps manufacturers and importers navigate the up-version to GUI 0158 Version 4.0 with confidence and continuity.

Chris Allen is CEO of analytical testing and regulatory support provider Broughton