GACP and GMP requirements in the production of medical Cannabis flowers in Switzerland

Understanding the Swiss regulatory context

The production of medical cannabis in Switzerland is governed by two distinct legal domains: the Narcotics Act (LStup) and the Therapeutic Products Act (LPTh). This dual framework shapes the responsibilities of cultivators, manufacturers, and downstream operators.

Swissmedic clarifies in its 2025 Aide-mémoire that cannabis containing ≥ 1.0% total THC is classified under Table a of the OTStup-DFI and therefore treated as a controlled substance subject to full narcotics control measures. Any plant material intended for pharmaceutical use remains under narcotics legislation while also falling under therapeutic product requirements once it enters pharmaceutical processing workflows.

Cultivation activities (as defined under OCStup) and pharmaceutical manufacturing (as defined under LPTh) are legally separate. This separation creates the need to clearly distinguish between GACP and GMP requirements and understand their exact scope in the Swiss system.

What GACP covers: the agricultural phase

Swissmedic identifies GACP — Good Agricultural and Collection Practice — as the appropriate quality framework for cultivation and primary handling of plant-based material, including medical cannabis.
In the Aide-mémoire 2025, Swissmedic emphasises that the implementation of GACP is not certified or inspected by Swissmedic, because agricultural steps do not fall under the definition of medicinal products under the LPTh. GACP is referenced in the introduction of Annex 7 of the GMP rules, but its enforcement is not part of Swissmedic’s responsibilities.

In practical terms, GACP covers the entire early phase of production: the cultivation of the plants, the harvesting procedures, and the initial post-harvest steps such as gentle drying, removal of excess plant material, and preparation of the bulk material for delivery. These activities fall under GACP as long as they do not alter or define the pharmaceutical quality profile of the final substance, which remains the responsibility of downstream GMP processes.

Swissmedic explicitly states that these basic post-harvest steps remain part of cultivation, and may be performed under a cultivation operating licence without triggering LPTh requirements, provided they do not modify the substance in a way relevant to pharmaceutical quality.

GACP therefore governs the “agricultural integrity” of the cannabis plant, ensuring consistent cultivation, hygienic handling, and traceability up to the moment of handover to the licensed buyer.

When GMP applies: the pharmaceutical phase

Swissmedic draws a clear line in its 2025 guidance between agricultural and pharmaceutical operations. Once the cannabis plant material undergoes any process that affects its pharmaceutical quality, it becomes subject to GMP requirements and therefore to the LPTh licensing regime.

According to the Aide-mémoire (Section 4.2.1):

“Medicinal products must be manufactured in accordance with the current guidelines on Good Manufacturing Practice for medicinal products… The manufacture of herbal medicinal products is subject to GMP Part I or Part II and the requirements of Annex 7”.

And, crucially, Section 4.2.2 specifies exactly which cannabis-related activities trigger GMP licensing:

• Final drying/decarboxylation,
• Adjustment and analysis of residual moisture according to pharmacopoeia requirements,
• Extraction (3.2.1),
• Purification (3.2.6),
• Distillation,
• Fractionation,
• Any processing aimed at producing an Active Pharmaceutical Ingredient (API),
• Packaging operations,
• Quality control and batch release.

In simple terms: anything beyond gentle, non-decarboxylating drying and trimming is GMP territory.

Swissmedic also emphasises that a pharmacy may not procure cannabis directly from a cultivator and use it to prepare magistral preparations unless the material has been transformed and released as an API by a manufacturer holding an LPTh establishment licence.

This guarantees that every quantity of cannabis used in medicinal formulations has passed through a validated GMP chain.

The legal boundary: LPTh vs. OCStup

OCStup (Narcotics Ordinance)

Covers:

• authorisation to cultivate cannabis for medical use,
• security, traceability, theft prevention,
• basic post-harvest steps that do not alter pharmaceutical properties,
• mandatory notifications and annual JARE reporting.

These activities are the responsibility of the cultivator and fall under the narcotics law.

LPTh (Therapeutic Products Act)

Covers:

• manufacturing steps that modify pharmaceutical quality,
• production of APIs or intermediates,
• QC/QA measures,
• batch release,
• distribution of processed products,
• magistral or industrial medicinal preparation.

Swissmedic states explicitly that once processing surpasses the agricultural domain, an LPTh establishment licence is obligatory and GMP applies in full.

This creates a clear and legally enforced boundary:
Cultivation = GACP + OCStup
Pharmaceutical processing = GMP + LPTh + OCStup

What is actually required in Switzerland?

Contrary to common misconceptions, Swissmedic does not require cultivators to be GMP-certified.
Instead:

• Cultivators must comply with GACP principles, but these are not certified by Swissmedic.
• Cultivators may only perform minimal post-harvest steps (soft drying, trimming).
• Any further processing requires a separate licensed partner operating under GMP.
• Pharmaceutical manufacturers, not cultivators, bear responsibility for applying the correct GMP classification to cannabis-based materials (API, intermediate, finished product).

Swissmedic is very explicit: the implementation of GACP is the responsibility of the manufacturer who will use the plant material, not of Swissmedic itself.

The regulatory model is therefore a collaborative quality chain:

1. Cultivator (GACP + OCStup)
   Produces high-quality raw cannabis flowers.
2. GMP Manufacturer (LPTh + OCStup)
   Performs decarboxylation, extraction, purification, drying to pharmacopoeia standards, or API production.
3. Pharmacy or pharmaceutical operator
   Uses GMP-released material to produce magistral or finished medicinal products.

This design ensures regulatory clarity, prevents uncontrolled processing, and aligns Switzerland with international pharmaceutical-quality standards.