The European Union Good Manufacturing Practice (EU GMP) Certification is similar to any other country’s GMP Certification, including the United States. It focuses on businesses that manufacture medicines, mainly the pharmaceutical industry, and sets the minimum standards they must meet to operate legally. These rules help governments to specify the quality of a medicine by the level of compliance the manufacturer meets under GMP criteria. 

The European Medicines Agency (EMA) qualifies cannabis as a medical product and therefore requires any cannabis product that’s distributed in the EU to be produced in an EU GMP Certified facility. This means forward-thinking operators interested in exporting cannabis to EU markets must be EU GMP Certified.

The certification reviews and documents nearly everything in an operation, including but not limited to:

• personnel
• supply chains
• building(s)
• clothing staff wears
• distribution chains
• storage setups
• documentation procedures

Because EU GMP for cannabis delves so deeply into the operation and ensures consistency across the board, securing the certification offers incredible benefits to businesses and consumers alike.

Check out the top three reasons why cannabis operators are getting EU GMP Certified below.

 2) EU GMP for Cannabis Opens Up New Markets

The EMA requires all medical products sold in the European Union to be manufactured in an EU GMP Certified facility. This means getting your operation EU GMP Certified opens up the entire EU market to your business.

This is an incredible advantage as the EU cannabis market is growing at a fast pace. At this point, over 20 EU nations have proposed medical cannabis legislation, with a few also working toward adult-use markets.

One emerging global player coming out of the EU is Germany. Germany’s medical market is expected to top €420 million in 2024, but the country cannot meet this demand on its own.[1] Only three federally approved suppliers are currently allowed to grow cannabis within the country; the rest of the demand is filled by imports mainly from the Netherlands, Canada, and Portugal, as well as Macedonia, Malta, Czech, and Colombia. In 2023 alone, Germany imported 30 tons of cannabis.

While US operators will have to wait for the plant’s federal status to change before they can export to Germany and other EU countries, securing an EU GMP Certification now will position them for exports in the future. Operators in other countries with federally legal markets, like Canada or Columbia, are currently able to export cannabis products, but if they didn’t start with EU GMP for cannabis, they’ll have to rework their entire business framework to meet EU GMP criteria before they can begin exporting.

If you’re a US operator planning to keep your business around for the long haul, earning your EU GMP Certification now means setting your business up for the future of global exports.

3) EU GMP Supports Long-Term Business Growth

With consistent operations in place, consumer trust earned, and new markets within reach, EU GMP for cannabis ensures long-term business growth.

Having a documented practice that’s EU GMP Certified allows manufacturers to easily mimic production in new locations, so businesses can expand and remain EU GMP compliant. It also allows operators to easily identify where changes or upgrades need to be made so they can continue to meet demand with a consistent product.

This is just the domestic side of things. With EU GMP for cannabis, operators are also positioned for long-term business growth with exporting opportunities. Instead of operating in a siloed state-specific or country-specific market, cannabis businesses can expand across oceans and establish a global presence. This can boost interest in a business’s brand and products both domestically and internationally.

Prioritize EU GMP for Cannabis Now, Reap the Rewards in the Future

The time to start working toward an EU GMP Certification is now. The process is long and detailed, especially if your operation and its SOPs are already established.

One major part of securing an EU GMP Certification for cannabis is the process you use for decontaminating your product before sending it to market. While the US doesn’t have specific requirements for decontamination in place, the EU does. Ionizing and non-ionizing radiation processes are both accepted, but using ionizing radiation (X-ray, gamma, and e-beam) comes with its own set of hoops to jump through outside of EU GMP criteria. Germany, in particular, charges exporters who use ionizing radiation around €4,500 per strain.

Radio Frequency (RF), the industry’s most popular non-ionizing radiation option, does not trigger any extra fees or licensing if used on products exported to the EU. Ziel’s RF technology, in particular, is already EU GMP Validated for microbial control and approved for organic operations by the U.S. Department of Agriculture (USDA) and the National Organic Program (NOP).

If you’re interested in learning more about securing your EU GMP Certification to prepare to export your cannabis products and are interested in leveraging the advantages of radio frequency microbial control, get in touch with Ziel today.

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.