EU-GMP Certification for Cannabis Producers

If you intend for your business, today or in the future, to participate in the global markets, you’ll almost certainly need to obtain EUGMP certification for your facilities and processes.

With legalization occurring around the world, and the resulting opening of markets for the import and export of cannabis for medical purposes and research, if your production facility is not EU-GMP certified you won’t be able to access certain significant markets. Ensuring your lab facility is compliant with the European Union’s Good Manufacturing Practices (EU GMP) is absolutely a requirement for products entering countries such as Germany. But it’s not absolutely necessary for all stages of production, and there is a lot of confusion in the market with regards to what is and is not required.

If your firm is producing and packaging the final product, you will require EU-GMP certification. Meaning you could be filling pre-rolls and packaging them. This doesn’t mean that the flower was grown in an EUGMP facility, but it helps. To reach EU-GMP standards in many final products it’s generally accepted that you will need GACP grown flower. For example, medical cannabis that has been grown in Uruguay is available in Germany. The flower was grown and harvested in Uruguay but processed in an EU-GMP-certified facility in Portugal. The final product came out of the process as EU-GMP certified, even if the inputs were not EU-GMP.

The overlap between GACP, GMP, and EU-GMP has created confusion in the cannabis industry. Most confusion has centred on at what point does the process of creating an EU-GMP product begin, and especially regarding how the step of drying must be handled. At the current time, the grow stage of medical cannabis should be to GACP standards, but the drying thereof must be within a GMP-certified facility. However, adding to the confusion, it’s still possible to get a product certified as EU-GMP without the drying being to GMP standard, as GACP drying can also be acceptable under certain conditions.


Overall EUGMP and CGMP / FDA-GMP are very similar, with some clear differences. Both provide for high-quality products and the differences have more to do with processes than products.

As an example, each year the FDA reviews the quality standards of each medical product to determine changes in any specifications or manufacturing processes. In contrast the European system is focused on reviewing the overall manufacturing and quality systems, and if it consistently produces consistent products. So EU-GMP verifies that the system to produce is consistent to guarantee consistency of production, whereas the US verifies that the processes followed result in consistent products. The European system is akin to an audit to verify output, whereas the US system focuses on the system by which the taxes are prepared.

Obviously, there is a lot more to each system, and we encourage you to read up on GACP / GMP / CGMP and EUGMP to understand how they flow into each other, and to determine the correct path for your business. We have been through the processes multiple times. Throughout the various processes quality, thoroughness, and organizational attention to detail is key.

  • Cannabis Industry Certifications
    • Good Agricultural Collection Practice – GACP
    • Good Manufacturing Practice – GMP
    • Current Good Manufacturing practice – cGMP
    • European Good Manufacturing Practice – EUGMP

Other certifications that would be helpful, and whose processes definitely should be considered are:

  • Global Certifications of relevance:
    • ISO Certifications: ISO-9001; ISO-13485; ISO-14001;