In a previous post, we discussed how some Canadian producers are selling excess inventory to export markets, including Europe.

In “The Europe Medical Cannabis Market,” Market Data Forecast reports, “The medical cannabis market in Europe is expected to grow from USD 4.96 billion in 2022 to USD 13.37 billion by 2027, growing at a CAGR [compound annual growth rate] of CAGR 21.96% from 2022 to 2027.”

Based on that report, Europe appears to be a significant marketplace for cannabis. But to sell into that market, the exporter must meet the region’s standards. In the case of Europe, those standards include the European Union’s Good Manufacturing Practices, referred to as EU GMP.

In their article, “A Look at Canadian Cannabis Exports,” published in 2021, The Business of Cannabis reported one reason why exports jumped in 2020. “In Canada, more cultivators gained the European Union’s Good Manufacturing Practices (EU GMP) certification, allowing them to export to that continent. More than a dozen Canadian LPs now have EU GMP certified facilities.”

Meeting EU GMP standards is critical for exporting into the European marketplace. But what is EU GMP and how does it differ from the standards Canadian companies already meet?

Health Canada requires that Canadian licensed producers comply with Good Production Practices or GPP standards. If you are a licensed producer in Canada, you are already familiar with GPP. If not, these standards are explained on the Health Canada website.

Essentially, GPP requires that cannabis businesses have appropriate procedures for all activities related to producing a product that is safe for public consumption. GPP mandates that systems be in place to ensure quality and traceability.

Good Manufacturing Practices, GMP, takes GPP further including requiring more stringent testing.

The Foundation of Cannabis Unified Standards (FOCUS) states, “GMP is the proactive part of quality assurance. It is designed to minimize the risks involved in all steps of the manufacturing process. A basic tenant of GMP is that quality cannot be tested into a product. It must be built into each batch of product during all stages of the manufacturing process.”

Originally designed for pharmaceutical products, GMP can be applied to any production process and is a requirement for those wishing to market medical cannabis in Europe.

The EU GMP standards are complex, and the information can be difficult to navigate, especially how it applies to cannabis.

But the Canadian government has published guidelines designed to help manufacturers meet GMP standards. Their guidance document has been written “with a view to harmonize with GMP standards from: the World Health Organization (WHO); the Pharmaceutical Inspection Cooperation/Scheme (PIC/S); the International Council on Harmonisation (ICH); the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); other regulatory agencies in other countries.”

While the EU is not mentioned specifically, these Canadian standards are a good starting point for cannabis companies considering exporting into other markets. These guidelines will help producers understand what is required and can be used as a stepping stone toward EU GMP certification.

According to the media, the EU standards are stringent, and certification can be time-consuming and costly. But with a market as large as Europe, Canadian companies are in a position to benefit from the opportunities that an EU GMP certificate can offer.

To access the resources quoted here, use the following links:

Business of Cannabis Canada cannabis Canadian cannabis EU GMP FOCUS Foundation of Cannabis Unified Standards Good Manufacturing Practices Health Canada quality standards