EMA Revises GACP After 19 Years: What the New Standard Means for Medical Cannabis Cultivation

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Introduction

After nearly two decades, the European Medicines Agency (EMA) has revised its Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin. Adopted in July 2025 and effective as of August, the update marks the first major change since 2006. For cultivators of medicinal cannabis, this is more than a regulatory update—it’s a complete modernization of standards.

The revision matters because GACP underpins the entire herbal medicines supply chain. From growers and processors to traders and manufacturers, every actor is expected to align with the new expectations. For cannabis, where consistency, traceability, and pharmaceutical quality are under intense scrutiny, these changes are transformative.

TL;DR

The EMA has published the first revision of the GACP guideline since 2006, bringing it closer to GMP standards and directly impacting cannabis cultivation across Europe. Key updates include:

• Indoor cultivation formally recognized in Annex 1 (climate, filtration, monitoring, equipment qualification)
• Stricter documentation and digital traceability requirements
• Enhanced contamination controls (PAs, TAs, PAHs)
• Environmental and biodiversity compliance (CITES, Nagoya Protocol)
• Clearer boundaries between GACP and GMP

Bottom line: Cultivators and processors must upgrade compliance systems, digitize batch records, and align operations with pharmaceutical-level standards. CANNAVIGIA provides the tools and consulting to make this transition seamless.

Why the Revision Happened

The herbal sector has changed dramatically since 2006. Indoor cultivation has become mainstream, legal frameworks for medicinal cannabis have expanded, and regulators have clarified the boundaries between GACP and GMP. The new guideline reflects these shifts and integrates advances in quality management, contamination prevention, and sustainability.

One principle stands out: the closer a preparation is to the final medicinal product, the stricter the requirements become. This alignment with GMP Part II and Annex 7 ensures that cultivation and primary processing now fit seamlessly into the pharmaceutical supply chain.

Key Updates in GACP Revision 1

Indoor Cultivation Officially Recognized

For the first time, indoor and greenhouse cultivation receive dedicated attention through Annex 1. The requirements include:

• Climate, humidity, light, and ventilation control with filtration systems
• Identification of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
• Daily digital monitoring of critical parameters
• Standardized cultivation processes for reproducibility
• Qualification of critical equipment and ancillary systems

For cannabis cultivators, this reads almost like GMP-light—clear recognition of controlled-environment growing.

Documentation & Traceability Tightened

The new guideline demands “unambiguous and unmistakeable” traceability. Expectations now include:

• Detailed batch documentation at every stage
• Daily records of process parameters for indoor grows
• SOP-driven documentation cycles
• Audit-ready systems with long-term record retention

Paper-based systems are unlikely to meet this standard. Digital solutions are rapidly becoming the norm.

Contamination Prevention Strengthened

The revision adds specific requirements to protect patient safety, including:

• Controls against pyrrolizidine alkaloids (PAs) and tropane alkaloids (TAs)
• Measures to prevent polycyclic aromatic hydrocarbon (PAH) contamination—ruling out drying with wood- or petrol-fired ovens
• Enhanced pest prevention and cleaning protocols

Environmental & Biodiversity Compliance

The new text goes beyond cultivation, embedding sustainability obligations:

• Compliance with CITES endangered species protections
• Adherence to the Nagoya Protocol on genetic resources
• Integration with the Global Biodiversity Framework

For cannabis, this aligns cultivation with global sustainability standards and supply chain ethics.

GMP Boundary Clarified

The revision clarifies the line between GACP and GMP:

• Drying, cutting, grading, and storage remain under GACP if not product-defining
• Steps that shape the final dosage form fall under GMP Part II or Annex 7

This reduces ambiguity and provides a clearer compliance pathway.

Before vs After: A Modernization in Practice

Before (2006)After (2025)General guidance on cultivation and harvestingExplicit requirements for indoor & greenhouse setupsLimited mention of QMSFormal Quality Management Systems across cultivation & processingBroad documentation expectationsDaily digital monitoring of CPPs; SOP-driven record lifecycleBasic facility standardsClimate, humidity, light, ventilation & filtration controlsNo strong GMP connectionAlignment with EudraLex Vol.4 GMP, Annex 7Minimal validation referencesValidation of processes & cleaning, with in-process acceptance criteriaGeneral equipment referencesCalibration & qualification requirements

What This Means for Cannabis Cultivators

• Indoor growers: Annex 1 finally recognizes your reality—but also raises expectations. Daily digital records, process validation, and equipment qualification are no longer optional.
• EU-GMP suppliers: The clearer handover between GACP and GMP means your contracts and SOPs must define where one ends and the other begins.

The era of broad interpretations is over. The new GACP closes loopholes and sets enforceable standards.

Our Perspective

At CANNAVIGIA, we see GACP Revision 1 as both a challenge and an opportunity. The challenge: cultivators must elevate their operations to meet pharmaceutical-grade expectations. The opportunity: digital platforms like ours make this transition manageable.

Our platform already anticipates the revision’s requirements:

• Digital batch records & daily monitoring of environmental and process parameters
• SOP-driven documentation and lifecycle management
• Equipment qualification evidence built into workflows
• Traceability from seed to batch release

Beyond software, our consulting team supports operators with EU-GMP readiness and Annex 1 compliance. Whether you’re scaling a greenhouse or running an indoor grow, we help ensure you stay compliant.

Conclusion

After 19 years, the GACP guideline has caught up with the realities of modern cultivation. For the cannabis sector, this is both validation and a call to action. Indoor growing is officially recognized, documentation is digitized, contamination prevention is tightened, and sustainability is embedded into compliance.

The message is clear: transparency and traceability are no longer optional. They are the standard.

👉 Now is the time to assess your compliance gaps. With CANNAVIGIA, cultivators can move from compliance risk to compliance readiness—confidently, digitally, and sustainably.