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EU GMP Certification for Medicinal Cannabis

Become EU GMP certified with our practical compliance solutions for medicinal cannabis manufacturers.

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Why you should choose PCS for medicinal cannabis certification

  • Experts in EU GMP for medicinal cannabis
  • Our services are worldwide
  • We usually respond within the hour to urgent requests
  • Full support in 1 to 2 weeks
  • EU GMP certification support from A-to-Z
  • More than 33 years of EU GMP experience

What is EU GMP certification?

The Good Manufacturing Practices (GMP) are a set of laws/regulations adopted by governments in most countries. These laws are designed to protect patients from sub-standard medicinal products. Medicinal cannabis containing THC is considered a medicinal product. All medicinal products must be produced under GMP conditions.

If you want to produce medicinal cannabis in the EU, or export your medicinal cannabis to the EU, you must implement the EU Good Manufacturing Practices (EU GMP) requirements. Before you can be GMP certified you will receive an inspection against the GMP requirements by your national healthcare inspectorate or a qualified auditor of your importer.

What we do

We’ve helped numerous companies worldwide with GMP implementation, our core expertise is EU GMP but can also implement the WHO GMP or U.S. FDA GMP. What we can do for you? Prepare your organization to the best of our ability. We have a set of plans, documents and standards to get you to EU GMP certification quickly.

We guide your organization from A-to-Z, from green field to your first commercial sale. We can do as little or as much as you need, we offer fully flexible packages.

Grow your business with EU GMP certification

EU GMP certification is the perfect opportunity to show your customers your dedication to quality. There are numerous producers of medicinal cannabis with poor quality and low prices that are not able to penetrate the EU market.

EU GMP allows you to control your quality, stability and market value. Become a master of your process and quality. The investment in GMP allows you to expand your business dramatically with higher prices.

Who we help

Medicinal cannabis companies in any stage of their lifecycle, this includes companies that are being set-up. We help -and have helped- companies on every continent.

  • If you are an importer of medicinal cannabis in the EU, you need the EU GMP

  • If you are a company producing/processing medicinal cannabis in the EU, you need the EU GMP

  • If you are a company based outside the EU and you export to the EU, you need the EU GMP

If you fit any of the listed categories, we can help you become EU GMP certified.

Jaap Koster, CEO of PCS, avatar

PCS managed the first medicinal cannabis EU GMP implementation worldwide for Bedrocan in 2016. Since then we’ve been working on 30+ medicinal cannabis projects in North and South Europe, Africa, North-America, South-America and Australia.

Eng. J.J.M. Koster
CEO of PCS

Our EU GMP certification solutions

  • EU GMP gap analysis

  • Project plan to remedy gaps (if any)

  • Facility construction support

  • GMP quality system implementation

  • Staff training

  • Project management

  • GMP license application and/or coordination with importer

  • GMP inspection preparation or QP audit preparation

  • Inspection / audit support

  • Post-inspection support

If you are interested in training your employees in the GMP's or GDP's, we are more than happy to help. PCS is both a consultancy and training institute to the pharmaceutical industry.

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Frequently asked questions

Can I have the cultivation area under GACP and the processing area under EU GMP?

This is a complex question. Get in touch with PCS to discuss your situation in detail. Our rule of thumb; money saved now by keeping GMP and GACP separate is negligible in comparison to the cost of hiring additional staff, having two separate quality systems and rework following future regulatory requirements for full GMP integration.

If I have an EU GMP quality system, can I apply for a GMP license?

No. A GMP quality system is a starting point but only 10% of the total GMP process. GMP touches everything; personnel, your building, the HVAC system, the clothing of personnel, the lab, your culture, your clients, suppliers and service provides. Everything that touches the product or affects patient safety is GMP too. It’s an enormous amount of work which cannot be covered by a few SOP’s.

When should I start taking the EU GMP into consideration?

From the very beginning. Are you making decisions on which equipment to buy? That’s a GMP decision. Are you selecting a builder? That’s a GMP decision. Are you hiring a grower? That’s a GMP decision. Everything you record under a GMP quality system early on doesn’t have to be redone later. Under EU GMP; If it’s not recorded it didn’t happen.

Can I do outdoor cultivation (in an open field) and process it elsewhere under EU GMP standards?

This is still possible at the moment. We know some companies are doing it, but this is not future-proof. EU inspectorates are beginning to gain a better understanding of medicinal cannabis and the inherent risks of outdoor cultivation to patient safety. Not all impurities can be removed downstream and therefore pose a risk to patients. Some impurities are very similar to the active substance and are extremely difficult to isolate.

I have a GMP certificate by a non-EU country, can I export to the EU?

No. You will need an EU GMP certificate issued by a competent authority OR a QP declaration from your importer in the EU.

Will I be inspected by EU GMP inspectors if I am outside the EU?

Not in 99% of cases. Germany is (at the time of writing) the only EU country that always inspects medicinal cannabis outside the EU. Typically, EU GMP inspections are carried out “by proxy” through the importer's authority person in the EU. However, if you have found a "finished product" (finished product), such as oil for example, that goes directly to the patient, without further purification: then you must be inspected anyway to become against EU GMP by a government agency.

How much does GMP certification cost?

This depends on what stage you are currently in, your equipment, the building etc. As a general rule of thumb, you should expect to spend no more than $150,000 USD from the concept stage to the export of your first batch to the EU on consultancy and training.

Plan an introductory meeting

During the introductory meeting we discuss your current status and what may be required to prepare you for the regulatory inspection/client audit. Subsequently we will draw up a project plan for your review.

  • Experts in EU GMP for medicinal cannabis
  • Our services are worldwide
  • We usually respond within the hour to urgent requests
  • Full support in 1 to 2 weeks
  • EU GMP certification support from A-to-Z
  • More than 33 years of EU GMP experience