Portugal’s medicines regulator has defended a year of tightened oversight and extended licensing delays throughout the country’s medical cannabis sector, telling operators that export certificates are now issued within 12 days and that the enforcement which unsettled the market stemmed from record-keeping and traceability failures rather than problems with the product itself.
Speaking at the Portugal Medical Cannabis (PTMC) conference in Lisbon yesterday (September 10, 2026) Vasco Bettencourt, Director of the Licensing Unit within Infarmed’s Inspection and Licensing Directorate, said the regulator had strengthened supervision of traceability, waste management and the qualification of customers and suppliers after weaknesses in those areas triggered criminal investigations. The problem, he said, lay in paperwork and partner checks, not in the medicines themselves.
Portugal is Europe’s largest medical cannabis exporter, but the enforcement drive and the permit backlog that followed is forcing many supply chains to reroute elsewhere, threatening the country’s long held reputation as the ‘doorway’ to European cannabis markets.
The fallout from Operation Erva Daninha
In May 2025, a judicial police investigation dubbed ‘Erva Daninha’ (Weed) led the Central Department of Investigation and Prosecution (DCIAP) to charge 24 defendants (13 individuals and 11 companies) with criminal association, aggravated trafficking, money laundering, and document falsification.
According to the indictment, as reported by Observador and Executive Digest, the criminal network forged import certificates to declare cannabis as bound for Democratic Republic of Congo, Guinea-Bissau, and Kenya, then rerouted it to European markets.
One certificate attributed to a Guinean authority carried an expiry date of February 30, 2024, a date that does not exist, and was still cleared. Around 5,533kg was declared for export to Congo across 2024 and 2025 with no corresponding import recorded by that country, and a 357kg consignment to Kenya in 2025 was set against an approved national import estimate of 300 grams.
The filings indicate Infarmed was deceived by the paperwork rather than complicit in it, but this has done little to quell criticism from both industry and authorities.
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How has Infarmed responded?
According to the regulator, 79,883kg of cannabis was exported in 2025, with more than 66,000kg shipped in the first half of 2026 alone.
A new national reporting platform and a quarterly reporting model, approved in June 2026, are designed to give the regulator verifiable production data. Infarmed says it has held more than 14 meetings with licensed companies since June to bed in the requirements.
During the session, an audience member challenged Bettencourt on the extended certification timelines, a key point of contention impacting operators since the police operation.
Permit issuance, they argued, currently takes around two to three months, against 28 hours in Switzerland. Bettencourt said the new platform had cut issuance to 12 days, adding that Infarmed expected to reduce timelines even further.
The regulator emphasised that suspension, revocation, and non-renewal of licences were ‘not objectives,’ but legal instruments necessary to crack down on non-compliance.
Much of the diverted product and falsified documentation uncovered over the past year, the regulator suggested, would have been caught earlier had traceability been properly maintained.
Ana Rita Martins, an Infarmed GMP inspector who joined Bettencourt on stage, said the regulator had expanded inspections, now covering existing and established operators rather than just new license applicants. While this was welcomed by industry stakeholders, it has led to frustrations over slower license renewals.
Business of Cannabis recently reported that Canadian flower exports to Portugal fell 86.6% from their April 2025 peak as volumes rerouted directly to Germany. Despite this, Infarmed’s own figures suggest total Portuguese export volume is still climbing.
The case has also turned attention to Infarmed’s own disclosure process, though not of the accuracy of its numbers.
Germany, Portugal’s largest trading partner, published its 2025 import records before Infarmed released its own. Germany’s Federal Institute for Drugs and Medical Devices (BfArM) recorded 55.1 tonnes of medical cannabis imported from Portugal in 2025 and a further ten tonnes in the first quarter of 2026, while Infarmed’s public activity document still ran only to November 2024.
In early August the opposition Iniciativa Liberal pressed the Health Minister on the licensing slowdown and on the missing 2025 export and prescription figures. Infarmed published them on August 21, two weeks later, recording 7,023 patient prescriptions for the year alongside the 79,883kg export total, consistent with Germany’s import tally and evidence the gap was one of timeliness rather than accuracy.
Ana Povo, Secretary of State for Health, had already said on June 26, 2026, that ‘corrective measures’ to strengthen the regulator’s oversight capacity were under way.
With many established global supply chains still routing through Portugal, these efforts will be welcomed by exporters. With that said, it’s as yet unclear whether the 12-day permit timeline and the new quarterly reporting regime will be sufficient to prevent supply chains from rerouting to alternative European processing hubs, many of which are faster and carry less reputational risk.
For now, Infarmed’s message to the room was that the crackdown is intended as a foundation for the industry, not a barrier.
