We use cookies to optimize your experience, analyze traffic, and personalize ads. Please choose whether you accept our use of non-essential cookies. Read More
Medicinal marijuana regulations
Medicinal marijuana products, like all medicinal products, must have either a Product License (Marketing Authorisation or MA), an Investigational Medicinal Product (IMP) licence for use in Clinical Trials or supplied as a Special under Regulation 167 of the Human Medicines Regulations 2012, and must be manufactured according to EU GMP guidelines.
Medicinal marijuana cultivation
For medicinal cannabis cultivation, a cleanroom envelope with the right HVAC system can create a controlled environment with the optimum growing conditions for producing the right cannabinoids. Cultivation areas, grow rooms, or hydroponic grow systems can be linked to GMP areas for processes such as drying, processing, packaging, and storing plant material.
MHRA-compliant cleanrooms
To comply with GMP guidelines, cleanrooms must control the level of airborne particulate and fulfil additional facility design requirements, e.g., fully-flush panels.
Medicinal products will need to be produced in a GMP cleanroom.
Cleanrooms for non-medicinal applications
ISO 14644-1 cleanrooms control airborne particulate levels and other environmental parameters—such as humidity and light—making them suitable for cultivation.
Non-medicinal products may be able to be produced in ISO cleanrooms.
Compliant Cannabis Production Facilities
Medical cannabis production requires strict regulatory compliance and contamination control. Our facilities meet licensing requirements with full environmental monitoring and chain of custody support.
Frequently Asked Questions
Medicinal cannabis products must be manufactured in accordance with EU GMP guidelines. Depending on your specific application, facilities must also hold appropriate licensing, such as a Product Licence (Marketing Authorisation), an Investigational Medicinal Product (IMP) licence, or be supplied as a Special under Regulation 167 of the Human Medicines Regulations 2012.
It depends on your end product. Medicinal products must be processed within a fully compliant EU GMP cleanroom. Cultivation, however, falls under agricultural rather than cleanroom requirements, and should follow Good Agricultural and Collection Practice (GACP) guidelines.
A well-designed cleanroom envelope, paired with a specialised HVAC system, creates a highly controlled environment with optimum growing conditions. This ensures consistent temperature, humidity, and light control to support the development of the exact cannabinoid profiles required in your grow rooms or hydroponic systems.
Yes. We can design your facility so that primary cultivation areas and hydroponic grow systems are seamlessly linked to strict GMP processing environments. This allows for safe and efficient operational flows when moving plant material through the drying, processing, packaging, and secure storage phases.
The design requirements depend on the cleanroom grade. Medicinal cannabis processing typically takes place in a Grade D environment, which must control airborne particulate levels and use finishes that can be easily and thoroughly sanitised. Higher grades bring stricter architectural requirements, such as fully flush wall and ceiling panels.
