What EU-GMP Looks Like in Practice: NACC Visits One of the Region’s Leading Medical Cannabis Producers

On 27 April 2026, the National Agency for Cannabis Control (NACC) conducted a technical visit to the production facilities of PharmaRolly Holdings B.V. in Skopje. The delegation, led by the Director General, Ms. Anila Alliu, visited the company following a meeting held during the Global Cannabis Regulatory Summit 2026 in London (19–21 April), where the company’s CEO, Mr. Stephen Malloy, invited the Agency to gain insight into its operations.

PharmaRolly has been operating in North Macedonia since 2019. Over the past seven years, the company has established a production system fully aligned with international standards and achieved EU-GMP certification in July 2024. Today, it exports medical cannabis products to Germany, Switzerland, and the United Kingdom, markets that require the highest levels of quality assurance, compliance, and operational control.

The Agency’s team had the opportunity to observe the entire production chain, including cultivation facilities operating in accordance with GACP standards, CO₂ extraction systems, drying and storage lines, and quality control procedures. The visit provided valuable insight into what the implementation of EU-GMP standards means in practice, not merely as a regulatory requirement on paper, but as an integrated system applied throughout every stage of production.

Albania is currently in the process of establishing its medical cannabis licensing system. The experience of PharmaRolly, together with the broader discussions held during the summit, offers precisely the type of practical knowledge that the Agency requires in implementing Law No. 61/2023.

 

"I would like to thank Steve Malloy for the warm hospitality and for providing us with the valuable opportunity to visit the EU-GMP certified facilities in Skopje. This exchange of experience offered us a highly practical perspective on the standards, discipline, and operational controls required throughout the entire process, from cultivation to quality management systems, serving as an excellent example of how medical cannabis can operate within a well-regulated framework." – Anila Alliu, Director General, National Agency for Cannabis Control (NACC)

 

"We are grateful for this type of cross-border cooperation. It helps the industry grow and, most importantly, improves access for patients." – Stephen Malloy, CEO, PharmaRolly Holdings B.V.