EU GMP Certification Valuable Asset for Cannabis Operators Looking to Export

Regulatory compliance and quality assurance are paramount for operators seeking to establish themselves in the cannabis industry. In the United States, for example, each state with a medical or recreational program has its own standards around pesticides, mold content, and other compliance factors. In Europe, a more comprehensive approach to regulatory compliance that mirrors the pharmaceutical market has been implemented.

Although the discussion around recreational cannabis in Europe is still progressing, strict regulations already govern production and distribution across the continent. With this, the European Union Good Manufacturing Practice (EU GMP) Certification has emerged as a crucial asset for cannabis operators, especially those looking to export cannabis to Europe’s medical cannabis markets.

What Is EU GMP Certification?

EU GMP Certification establishes the minimum standard that all European medical manufacturers—including cannabis cultivators and manufacturers—must meet to legally distribute their products under the European Medicines Agency (EMA). This means any domestic cannabis operators in the EU and any companies outside the EU seeking to export to the EU must be EU GMP Certified.

Specific regulations can vary depending on the product type and intended use, but essentially, the certification considers factors such as:

  • Premises and equipment
  • Documentation and records
  • Storage and distribution
  • Complaints and product recall
  • Production controls
  • Quality control
  • Audits and inspections

Germany, the largest importer of cannabis in the EU (30 tons in 2023), has taken it one step further, requiring an AMRadV license for all strains decontaminated with ionizing radiation (X-ray, gamma, and e-beam). This license can take around 12 months to secure and cost around €4,500 per strain.

Current Legal Cannabis Markets in Europe

Over 20 EU nations have proposed some sort of medical cannabis legislation, with a few also laying groundwork for an adult-use market.[1] At this point, you won't find recreational markets like Canada's or the United States’, though adult-use cannabis is still available in certain countries with specific program measures in place, and in other EU countries, patients can secure cannabis for adult use with a prescription.

  • Spain: Cannabis is decriminalized and personal consumption and private cultivation are legal in Spain; however, selling cannabis is illegal. “Social clubs” numbering more than 1,000 nationwide operate in a legal gray area.
  • Netherlands: While recreational cannabis is technically illegal in The Netherlands, the sale and possession of small quantities are tolerated in licensed "coffee shops" under a policy of "de facto" legalization.
  • Luxembourg: Last year, Luxembourg legalized the possession, consumption, and cultivation of up to three grams of cannabis, though public purchasing is still not allowed.
  • Malta: In 2021, Malta became the first EU country to legalize cannabis for adult use using non-profit cooperatives instead of dispensaries.
  • France: A three-year pilot medical program is now halfway complete. However, the government recently announced it’s discontinuing the use of cannabis flower in the program.

Germany is leading the way on proposed legislation changes that are expected to have a ripple effect across the EU and the globe. With the potential for their market to grow 7-10X in the next 18 months, the country’s AMRadV license requirement has cultivators with plans to export to Germany reconsidering their post-harvest decontamination technology choices.

Radio Frequency Decontamination Approved for EU GMP Facilities

For cannabis operators looking to earn or maintain their EU GMP Certification but in need of an effective mold remediation solution that won’t require AMRadV licensing, Radio Frequency (RF) solves both these needs.

RF decontamination is already used for food safety in established agricultural markets like nuts and dates. It’s recognized by the U.S. Department of Agriculture (USDA) as an organic process. And, as of January 2024, Ziel’s RF technology has officially received its EU GMP Certification for microbial control.

This certification allows cultivators wanting to export, or currently exporting, to Germany to avoid AMRadV costs while still maintaining their EU GMP status.

Incorporate RF Decontamination into Your EU GMP Operation

Curious to learn more about RF microbial decontamination and how it can earn you more money without compromising your EU GMP Certification? We’ll walk you through the power of Radio Frequency and what it means to treat your flower organically, without the side effects of ionizing radiation. Get in touch with us today.