BERLIN — Germany’s rapid expansion in the plant-based medicine sector has now reached a critical turning point. The Federal Institute for Drugs and Medical Devices (BfArM) confirmed that the country has exhausted its 2025 import ceiling of 122 tons, triggering a temporary pause on new import licenses while authorities reassess demand projections with the International Narcotics Control Board (INCB).

Surge Beyond Expectations

Imports surged over 400 percent year-on-year, driven by a sharp rise in patient demand following partial legalization in 2024. During the first half of 2025, Germany imported roughly 33 tons from partners including Canada and Portugal, with additional shipments from Denmark and Australia.

While the record pace underscores Germany’s position as Europe’s largest therapeutic market, it also highlights a growing challenge — ensuring stable domestic supply while adhering to international quota systems designed to prevent over-importation.

Temporary Pause, Not a Ban

Officials clarified that this is not a ban or restriction on existing importers. Current licenses and planned deliveries will continue, but no new applications can be approved until the INCB approves Germany’s revised estimates.
The BfArM emphasized that annual demand figures must remain conservative under international law to maintain compliance with UN conventions. Once updated quotas are approved, new import permits are expected to resume.

Access Tightens Under New Rules

Alongside the import pause, Germany’s federal cabinet has approved new restrictions on online prescriptions and mail-order delivery. All prescriptions will now require an in-person medical consultation, effectively ending the telemedicine boom that had become a major channel for patient access.
Health Minister Nina Warken said the move aims to “restore medical integrity” and ensure that prescriptions are based on genuine doctor-patient interactions rather than virtual assessments. The policy shift marks a clear attempt to stabilize a market that grew faster than regulators could monitor.

A Global Pattern

Germany’s recalibration mirrors global trends. Similar bottlenecks have occurred in Canada, Australia, the U.K., and Israel, where rapid growth in patient access outpaced regulatory forecasts and domestic capacity. Experts note that the challenge lies not in enthusiasm for reform, but in infrastructure catching up to policy.

The Road Ahead

As Germany works to expand controlled regional sales under its “Pillar 2” framework, analysts say the situation could accelerate investment in local cultivation and pharmaceutical-grade production.
For now, the import pause serves as both a warning and an opportunity: the market’s growth potential remains vast — but long-term stability will depend on how quickly Germany builds capacity at home.