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SOMAÍ Secures Product and Distribution Authorization in Portugal

Jan. 20, 2026 by SOMAÍ Pharmaceuticals

Lisbon, Portugal — [20 January 2026] — SOMAÍ, a leading EU-GMP-certified vertically integrated Multi-Country Operator (MCO) specializing in cannabinoid-based medicines, today announced that it has received official approval from INFARMED, Portugal’s National Authority of Medicines and Health Products, to commercialize three of its medical cannabis products in Portugal, and also received independently a Portuguese GDP distribution license that enables direct commercialization and supply.

This market authorization ACM and distribution license approval marks a significant milestone for SOMAÍ, enabling the company to supply the Portuguese medical cannabis market with EU-GMP-certified cannabinoid medicines manufactured in Portugal, in full compliance with national and European regulatory standards.

Strengthening a Highly Selective Market

The Portuguese medical cannabis market currently features only a small number of approved cannabis-based preparations, reflecting INFARMED’s rigorous authorization process for placing products on the market. According to publicly available regulatory data, the list of cannabis-based medicines and preparations approved for sale in Portugal totals approximately a dozen products, and with our recent authorizations this incrementally expands options for patients and prescribers. The approval from INFARMED further strengthens Portugal’s position as a leading European center for pharmaceutical cannabis manufacturing and innovation, but also for access now.

By introducing our advanced oils into Portugal, SOMAÍ is positioned to open up more demographics of patients that want new advanced extracts, and underscores the pharmaceutical quality of SOMAÍ’s large portfolio of EU-GMP stabilized products and its ability to navigate hard-to-access markets with proper EU pharmaceutical dossiers.

Supporting Patient Access with Portuguese-Made Medicines

With these approvals, SOMAÍ is proud to contribute locally manufactured medicines to the national healthcare system while meeting the same stringent quality, safety, and consistency standards required across the most rigorous international markets. SOMAÍ has two other dossiers in the approval process and three more being finished for Portugal in 2026, as well as other dossier markets.

“This approval represents an important moment for SOMAÍ and for Portugal’s medical cannabis ecosystem,” said Michael Sassano, Founder and Interim CEO of SOMAÍ. “Having an official medical market-authorized product in Portugal and the EU is another milestone accomplished that will supply Portuguese patients, but the bigger picture is that SOMAÍ has already invested significantly in developing comprehensive regulatory dossiers that can access the hardest medical markets in European and global markets, including Spain, France, Poland, New Zealand, and other strictly medical markets. SOMAÍ’s investment in dossiers further reinforces our strategy to reach all cannabis markets and provide access to our extract portfolio to patients in all approved markets.”

In addition to these product authorizations, SOMAÍ obtained its own Portuguese GDP distribution license, enabling the company to commercialize and supply its approved products directly into the Portuguese medical cannabis market while establishing Portugal as a centralized distribution hub for its international operations. Through this licensed infrastructure, SOMAÍ can also receive EU-GMP finished-dosage extracts and EU-GMP-certified flower from approved partners worldwide and export them directly to all SOMAÍ-served markets via a single, compliant platform. This milestone marks SOMAÍ’s second completed distribution license and product sponsorship, with at least two additional distribution licenses targeted for 2026, further strengthening the company’s global pharmaceutical supply network.

About SOMAÍ

SOMAÍ is a leading EU-GMP-certified vertically integrated Multi-Country Operator (MCO) with a global footprint of distribution for one of the most advanced EU-GMP-certified cannabinoid-containing pharmaceutical portfolios.

The company owns a state-of-the-art manufacturing facility, SOMAÍ Pharmaceuticals, and indoor cultivation NovaSoma in Lisbon, Portugal, and maintains global sales teams across the largest medical cannabis markets. Through strategic acquisitions and global brand partnerships, SOMAÍ is building a robust pipeline of innovative cannabis-based therapeutics for patients worldwide.