Insights extracted from a panel discussion at PTMC – Portugal Medical Cannabis on September 10, 2026. Panellists: Riccardo Longato (Clear), Luis Meirinhos Soares (Bring Knowledge), Maria Villota (Flextem Biopharma) and José Veracruz (Canna.biz). Moderated by Ricardo Baca (Grasslands). Photo credits: Renato Velasco
Growing Officially Became Manufacturing
In a panel titled “The Future of EU-GMP: Building the Next Generation of Cannabis Products and Operations” unter PTMC (Portugal Medical Cannabis) 2026, four regulatory and quality experts opened with two numbers designed to sit uncomfortably next to each other.
In the first six months of 2026, Portugal exported 66,000 kilos of medical cannabis, while writing roughly 5,000 domestic prescriptions in that same window. One country, one supply chain, two entirely different relationships with the same plant. Moderator Ricardo Baca, founder of the cannabis communications agency Grasslands and a former 25-year journalist at the Denver Post, framed the whole panel around that gap: Portugal has built a pharmaceutical export machine over the last decade, and the rulebook that machine runs on has just been rewritten.
That rewrite is not cosmetic. Cultivation, for the first time, has been pulled properly into the same regulatory logic as manufacturing, with GACP (Good Agricultural and Collection Practice) moving substantially closer to the requirements of EU-GMP (Good Manufacturing Practice).
As the panel repeatedly pointed out, this is not a cannabis-specific invention. GACP governs the plant while it is still a plant, from cultivation through drying, and EU-GMP takes over from processing through to final release, the same framework that has governed hundreds of other medicinal plants in Europe for decades. What has changed is how tightly cultivation is now expected to document, validate, and prove its own consistency, closing what several panellists described as the last major grey area between the field and the finished medicine.
This is also a panel with unusually credible referees. Between them, the four panellists have sat on the regulator’s side of a GMP inspection, built compliance software used across Europe’s cannabis supply chain, run quality assurance for a Portuguese medicinal gas manufacturer, and co-founded a certification body serving cultivators from Italy to Latin America. Their shared verdict was blunt: EU-GMP was never designed to be bureaucracy for its own sake, and an industry that keeps treating it that way is going to keep failing to be taken seriously by the regulators, doctors, and patients it depends on.
The Numbers and Frameworks Behind the Panel
This panel dealt more in regulatory architecture than dollar figures, but the facts on the table were still concrete:
- Portugal exported 66,000 kilos of medical cannabis in the first six months of 2026 against roughly 5,000 domestic prescriptions in the same period, a gap the panel used to frame the entire discussion around who EU-GMP is actually supposed to protect.
- Luis Meirinhos Soares, founder of Bring Knowledge and a former GMP/GDP inspector at INFARMED for 25 years, confirmed that under EU rules there is no such thing as mandatory GACP certification. Responsibility for qualifying a cultivation supplier sits with the buyer, a position he said is explicit in the European Medicines Agency’s own published question-and-answer guidance.
- Riccardo Longato, co-founder of the compliance certification body Clear, pointed to a working definition from the textbook Introduction to Statistical Quality Control (Montgomery): “quality is inversely proportional to variability.” The more uncontrolled the process, the more variable, and riskier, the outcome, a concept he argued applies directly to a biologically complex product like cannabis.
- Under EU-GMP’s Annex VII framework for herbal medicinal products, the panel noted that cultivation steps now fall under GACP specifically because Annex VII and EU-GMP require it, not because GACP exists as a standalone standard. José Veracruz drew a direct parallel to Annex VI, which governs medicinal gases, the framework he spent over a decade working under at Linde Portugal before moving into cannabis quality assurance.
- The panel’s account of the last major cultivation rulebook rewrite centred on one consistent theme: cleanliness, documentation, and validation requirements for growers have moved substantially closer to GMP standards, closing the ambiguity around where GACP ends and GMP begins.
5 Key Takeaways
- EU-GMP exists for the patient, not the auditor. Multiple panellists returned to the same point from different angles: the opening line of EU-GMP’s own pharmaceutical quality system chapter states that its aim is patient protection. A company that treats compliance as a box-ticking exercise for inspectors, rather than a system built around the person eventually taking the medicine, has misunderstood what it signed up for.
- Consistency, not perfection, is the actual GMP mandate. The panel was clear that GMP does not require an impossible level of precision in every input. What it requires is a defined, documented working range that a company can prove it repeats, batch after batch, the same logic already applied to hundreds of other medicinal plants long before cannabis arrived.
- The line between GACP and GMP is disappearing. With the latest cultivation rulebook, cleanliness, documentation, and validation requirements for growers have moved substantially closer to full GMP standards. Several panellists argued cultivation should simply be folded into GMP’s Annex VII outright, removing the ambiguity altogether.
- Responsibility for supplier quality sits with the buyer, not the certifier. There is no mandatory GACP certification under EU law. When a manufacturer buys cultivated cannabis, the legal responsibility for confirming that supplier meets the required standard rests with the manufacturer itself, not with any third-party badge on the paperwork.
- Sloppy scientific language is a credibility problem, not a style choice. Terms like “strain,” “curing,” and undefined terpene claims have no basis in peer-reviewed literature or harmonised regulatory usage. The panel argued that an industry still leaning on consumer marketing vocabulary, instead of pharmaceutical terminology, makes it harder for regulators and doctors to take medical cannabis seriously.
Bemerkenswerte Zitate aus dem Panel
"The campaign signs that ultimately passed adult-use cannabis in Colorado, they had two words: 'Regulation works.' That was the message that ultimately got through to voters, to consumers, to patients."
"The paper saves you. Whenever there is an issue, you look for a paper, you want to have that information. First, I think that's where it breaks down. You miss that part of walking before running."
"For medical gases, we have Annex VI, which covers everything from the air we use to make the gas to the finished medicine. So why not include GACP inside Annex VII? Then this discussion of GACP, GMP, can I do it, can I not do it, it stops."
"GMP is not about you, it's not about the equipment, it's not about the flower. It's about the patient. All the regulations and all the writings of these guidelines are there to, in some way, protect the patient, and make sure you do it consistently."
"How do you expect to be taken seriously if you continue using non-harmonised language? Strain is not applicable to plants, it's only applicable to bacteria and fungi, and cannabis is a plant. Does it matter? Well, it shows that you have a scientific basis."
"If you open EU-GMP chapter one, pharmaceutical quality system, the first few words are saying the aim is patient protection. This is the beginning of everything. Without that, there is nothing else."
"Quality is inversely proportionate to variability. The more I have an uncontrolled process, the more the outcome is not controlled, and theoretically the quality at the end could be much more variable and risky throughout the process."
"It's not good manufacturing practices, it's safety of the patient, and that needs to be changed. The mentality needs to be changed, so we are not just GMP, good manufacturing practices. It's what it stands for."
"We focus very much on clean validation, on microbial content. We are not a cannabis company. We are clean. Everything is perfect from the beginning."
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