Insights extracted from a panel discussion at PTMC – Portugal Medical Cannabis on September 10, 2026. Panellists: Dr Vasco Bettencourt (INFARMED) and Ana Rita Martins (INFARMED). Moderated by Laura Ramos, CannaReporter.
Portugal Medical Cannabis: What Changed Between PTMC 2025 and PTMC 2026
The Numbers
- 2025 full-year exports: approximately 79,883 kg of medicinal cannabis.
- H1 2026 exports: already over 66,000 kg in the first six months, putting the country on pace to comfortably outstrip 2025.
Bettencourt was clear the figure should not be the headline: “the relevance of the Portuguese medicinal cannabis system should not be measured only by the volume of its exports.” His preferred metric is the maturity of the systems underneath the volume.
Infrastructure Delivered Since PTMC 2025
- MDS platform live. The national narcotics and psychotropic substances system, previewed at PTMC 2025, entered production earlier in 2026 and is now the working platform for issuing import and export certificates. Bettencourt publicly credited the companies that collaborated on its implementation.
- New quarterly reporting model. Approved in June 2026, replacing the previous declarative report and giving INFARMED a “clear and more consistent understanding” of what authorised entities are actually doing.
- 14+ meetings on the reporting model alone held by INFARMED since June 2026 to walk operators through how to complete the new fields.
The Framing Shift
The most important signal from the address is not a number, it is a change of narrative. INFARMED is now positioning strict regulation as a protection for compliant operators, not a tax on them:
“A strong regulatory system protects companies that invest in compliance from the risk created by weak practices elsewhere in the supply chain. It protects their credibility, their commercial relationships, and the reputation of the sector as a whole.”
Bettencourt also pushed back on the standard industry reflex that regulatory requirements are obstacles: “They should also be seen as an opportunity to strengthen internal controls, improve practices, and increase confidence in the sector.” For serious European operators, this is the sentence to circle.
Moving forward into 2027
Portugal’s medicines regulator used its slot at PTMC 2026 to draw a line under what industry has been calling the “INFARMED blackout”, the 18 months of thin communication that coincided with several licence revocations and a wave of criminal investigations. Dr Vasco Bettencourt, a director at INFARMED with responsibility for the licensing and certificate-issuing side of medical cannabis, did not dispute the perception. He described it instead as a forced pause while INFARMED recalibrated its whole supervisory approach, and pointed to 40 meetings held with companies since June 2026 as proof the channel is now open again.
The regulator’s message on where enforcement is now focused was unusually explicit. Dr. Bettencourt named three priorities: traceability, waste management, and the qualification of suppliers and clients. Notably, product quality was not on the list. In his words, INFARMED has not encountered real quality problems in Portuguese medical cannabis. What it has encountered is poor record-keeping, and this is what has been driving the licence-related enforcement actions the market read as a crackdown.
On operations, Dr. Bettencourt disclosed a figure the room clearly did not expect: the median turnaround for import and export certificates is now 12 days, a long way from the two to three months operators say they routinely experience. Delays, he argued, come from the documentation now demanded (certificates of analysis, supplier qualification files, country-of-origin production estimates from the INCB) rather than from INFARMED capacity. Ana Rita Martins, the INFARMED director who oversees the inspections programme, linked the same documentation drive to slower licence renewals, explaining that the 2021 to 2022 licensing boom created a cohort of operators who had been running for four or five years without a full follow-up inspection, and that inspecting them properly (in parallel with the ongoing criminal cases) has crowded the inspection calendar.
Two industry proposals landed on the table in the Q&A. José Veracruz, head of QA and Qualified Person at Portuguese producer Canna.biz and president of the College of Industrial Pharmacists, offered to co-produce a formal question-and-answer guidance document with INFARMED, and got a yes in principle from both regulators. Ivanshu Shantilal, CEO of Portuguese licensed producer AceCann, pushed for a mandatory, single electronic traceability and waste platform along the lines of Metrc in the United States. Dr. Bettencourt was open to the idea, but flagged the two constraints: it needs a legislative change, and it needs the Portuguese Environmental Agency in the room. The takeaway for operators is straightforward. Rigour is not going away, dialogue is being rebuilt, and the companies that invest first in clean records will spend the least time explaining themselves.
5 Key Takeaways for Operators
- The “blackout” is officially over, but on INFARMED’s terms. Dr. Bettencourt effectively confirmed the communication breakdown was real and framed it as a recalibration, not a policy. Test the new posture by requesting meetings on specific technical questions rather than general grievances. Forty meetings in three months suggests the door is genuinely open.
- Three enforcement priorities, and quality is not one of them. Traceability, waste management, and supplier and client qualification are where inspections are finding deficiencies. Audit these three areas before any renewal or inspection. If a company lost its licence in the last 18 months, this is almost certainly why.
- 12 days is the new benchmark for import and export certificates. If yours is taking materially longer, treat it as a documentation problem on your side, not a queue problem on INFARMED’s. Front-load the certificate of analysis, the supplier qualification file, and confirmation that the country of origin has published INCB production estimates. Without the last of these, the certificate will not be issued at all.
- Licence-application timelines have not worsened structurally, the paperwork has. New applicants should budget for materially more documentation than three years ago, including parent-company checks and qualification plans for future suppliers and clients. This is the honest number to put in front of investors, not a headline processing time.
- Two industry-led wins are available if someone drives them. A co-produced Q&A guidance document with the College of Industrial Pharmacists was accepted in principle in the room. A mandatory Metrc-style traceability and waste platform is a longer game requiring legislation and the Environmental Agency, but INFARMED signalled it wants the same thing. Both are advocacy openings for trade associations right now.
Notable Quotes from the Panel
"Probably it was during that recalibration, and when we don't have all the answers to give to companies, that the message that passed to the companies was, they don't hear us, INFARMED is on blackout. So we were, in fact, dealing with these growth pains that this sector had in this last year."
"Since June 2026, we held 40 meetings with companies. We really defined what are the requirements that we are addressing more, the qualification of suppliers and customers, the waste management, the traceability. All those aspects that in the past we had into account, but not with the perspective that we have today."
"We didn't have real problems with the quality of products, and that's, for us, a reason to be happy with that. The problem was most of them related with the traceability, waste management, and the qualification of the business partners by the company."
"The median time that we are taking to issue a certificate is now 12 days in the new platform. On the process of evaluating the certificates, we include several requirements that we didn't have before, and that was one of the situations we had to improve after issuing some certificates taking into account documents that were not valid, that were falsified."
"Taking account the boom of registrations in 2021 and 2022, in '23, '24 and '25 was the time to see how they were working. All the criminal investigations that are part of INFARMED competencies that happened also triggered this need for these inspections, but they were already in our plan."
"As we were finding some deficiencies in the traceability, in the waste management, in qualification of clients and suppliers, that was important for us that they were corrected. With many inspections, all of the inspection reports that were needed to be done and all the assessments of the proper plans that were presented, of course, it contributed also for some delays."
(On production versus export figures) "To know the quantities that are really produced in Portugal, we need to have accurate records. Without accurate records, we can give you a number, but it's a number we can't rely on. You can produce a big quantity, but if you don't use that quantity it will be treated as waste. Should we count that as production? Probably not."
"Probably some of those situations that resulted in criminal investigations would be avoided if the records and the traceability were well done. Probably the companies are not prepared and are not aware of the importance of having these records with this specificity and this precision."
(On import certificate requirements) "If the country of origin doesn't have estimates of production, we won't issue a certificate of importation. Even if the company has an authorisation, we don't issue. The document base is the certificate of analysis, the qualification of the supplier, and the authorisation of the entity of origin."
(Asking the panelists) "I would like to know if INFARMED would consider issuing a typical questions guidance or something similar, mainly on production and manufacturing of medicines. Inside the Society, and mainly on the industrial side, we would be more than willing and able to work on that document with you."
(Responding to the Q&A proposal) "There are several documents organised that way as question and answers, and perhaps we can go that way taking into account all the experience that we have gained in these months. It's something that we can think about. Perhaps it's an idea that might help both parts on dealing with it."
(On how the regulator sees cannabis) "We don't have specialised teams on the regulators to treat medicinal cannabis. Most of the teams come from the background of the pharmaceutical industry, so you should bear in mind that the requirements will be very similar to the pharmaceutical industry. We should give more view to medicinal cannabis, be more robust, more strength, so this society doesn't see this sector as an alternative sector, an alternative medicine."
(Responding to Ivanshu Shantilal's Metrc-style platform proposal) "All of us wish to have something like that in place. It's something that takes time. The MDS platform took almost two years and a half to implement. In that solution we have to include the Portuguese Environmental Agency. Legislation has to be changed, and we can't do that. We hope in the future the legislation will be adapted and updated with these issues."
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