Europe has become the epicenter of global medical cannabis developments in recent years. While it's been a slow, often disjointed start, momentum on the continent is finally building, with several major countries establishing regulated markets. By the end of 2023, Prohibition Partners project the EU's collective medical cannabis market, including the UK, will hit €516 million ($547.39 million).
Yet, collectively, this patchwork of markets across the continent is among the most tightly controlled in the world. Hence the slow start. Cannabis, classified as medicine, requires producers, processors, importers, and exporters to achieve the European Union's Good Manufacturing Practices (EU GMP) to participate legally.
With EU-GMP as the price of entry into the lucrative EU markets, it has quickly become a primary goal for multinational cannabis companies.
What is EU-GMP Certification?
According to the European Medicines Agency, "Good Manufacturing Practices (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes." Furthermore, "Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP."
It requires that medicines "are of consistent high quality, appropriate for their intended use, and meet the requirements of the marketing authorization or clinical trial authorization."
GMP vs. EU-GMP: Critical Differences
In the US, many cannabis producers are already involved in the Good Manufacturing Practice (GMP) certification process, with foresight to a possible future of federal regulation. The GMP is a US-regulated certification that differs from what's mandated under EU-GMP.
Many consider the EU-GMP more stringent, with a greater degree of specifics than the US version. As originally summarized by BioBoston Consulting, here are just a few of the ways GMP certifications differ between the US and the EU:
- Regulatory Authority: The EMA enforces GMPs in the EU, while the FDA oversees GMP enforcement in the US.
- Quality Risk Management: EU GMPs emphasize a systematic approach to quality risk management, while US GMPs offer more flexible implementation of risk-based approaches.
- Documentation and Record Keeping: EU GMPs have detailed requirements for documentation, while US GMPs provide general expectations without specific guidance.
- Process Validation: EU GMPs require a formal process validation protocol, whereas US GMPs advocate a science- and risk-based approach without mandating a specific protocol.
- Quality Management Systems (QMS): EU GMPs require a comprehensive Pharmaceutical Quality System (PQS), while US GMPs emphasize a quality control unit and quality systems without a PQS mandate.
- Inspections and Audits: The EU focuses on routine regulatory inspections, while the US FDA uses a risk-based approach to target higher-risk facilities or those with a noncompliant history.
- Product-Specific Guidelines: EU GMPs provide detailed product-specific guidelines via annexes, while US GMPs largely rely on general requirements without product-specific guidelines.
Who Needs EU-GMP Certification?
As a general rule, achieving EU-GMP certification is paramount if you plan to participate in the EU market (and even in the related non-EU market of the UK). However, there are three specific categories of participants to which the rules apply:
- EU-based importers of medical cannabis
- EU-based producers and processors of medical cannabis
- International medical cannabis exporters to the EU
Outside of the EU-based players, a growing number of international exporters have already obtained EU-GMP certification. A few notable names include Canadian companies Eve & Co. subsidiary Natural MedCo, The Green Organic Dutchman Ltd, and most recently, Canopy Growth.
Outside of Canada, many less-famous cannabis-producing countries are also achieving certification. These include CB21 Pharma in the Czech Republic, MG Health in Lesotho, and Clever Leaves in Colombia, among many others.
International Success Hinges on EU-GMP Certification
According to Prohibition Partner's The European Cannabis Report: 8th Edition, "Europe remains the center of attention when it comes to the development of the medical cannabis industry at a global level. This is not only because it has the potential to become the largest market, but also because it is open to international players."
While Canada and the Netherlands continue their dominance as the two largest suppliers, other international sources are starting to pop up. These include Australia, Africa, South America, Israel, the Caribbean, and even internal European countries.
With an increasing number of sources fueling the burgeoning EU medical cannabis market, the pressure is on. The EU is set to become a gold standard for the rest of the world to replicate.
Achieving an international foothold requires action today — starting with EU-GMP. Locking in the critical relationships early with EU importers makes it possible to secure a foothold for success in the EU and, eventually, globally.
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In the US, in the EU, and beyond, GMP certification is increasingly a pivotal component to success and quality. The fundamental concept behind GMP is to embed it into TSRgrow’s operational DNA. With our TOTALgrow Solution approach, we help ensure your cannabis cultivation facility is not only compliant but also optimized for consistency and quality.
Interested in international expansion? We’d love to help. Let us help you future-proof your cultivation practices to meet the stringent requirements of EU-GMP. Visit us online to learn more or contact us today for a complimentary consultation.
