Key regulatory developments in July 2026 — EMA publications, national authority announcements, BfArM updates, inspection findings and policy developments affecting pharmaceutical cannabis operators across Europe.
The ECI Regulatory Watch is a monthly digest of regulatory developments relevant to pharmaceutical cannabis operators, healthcare professionals and investors in European markets. Each edition covers EMA activity, national authority announcements, significant enforcement actions and policy developments.
The EMA Committee on Herbal Medicinal Products (HMPC) continued its review of Cannabis sativa L. monograph data during July 2026. The HMPC is considering updates to reflect evolving clinical evidence and quality standard developments since the last monograph revision. Cannabis manufacturers relying on monograph compliance for their quality specifications should monitor HMPC publications for any amendments.
The EMA signal assessment process continues to monitor adverse event reports for authorised cannabis-based medicinal products including Epidiolex (cannabidiol) and Sativex (nabiximols). No new safety signals requiring label changes were identified in July. The EMA pharmacovigilance database (EudraVigilance) remains publicly searchable for adverse event data.
EudraGMDP records show continued active GMP inspection programmes across EU member states for cannabis manufacturing facilities. New GMP certificates issued in July included facilities in Portugal and Denmark. Manufacturers seeking to export to Germany should ensure their GMP certificates are current and registered in EudraGMDP before submitting BfArM import applications.
BfArM import permit processing times for pharmaceutical cannabis products remain approximately 4–6 weeks from submission of complete application. Applicants should ensure that GMP certificates for the manufacturing facility, starting material CoAs, finished product specifications and analytical test results are included in the initial application to avoid requests for additional information that extend processing time.
BfArM has continued enforcement action against cannabis products found on the German market that do not meet pharmaceutical quality requirements. Operators marketing cannabis products in Germany should ensure that all products are manufactured to EU GMP standard and that import permits are current before supply to German pharmacies or dispensaries.
Implementation of the Cannabisgesetz continues. The social club (Anbauvereinigungen) framework for adult use is operational, with growing numbers of registered clubs. The adult use framework is separate from the medical cannabis market but has contributed to broader normalisation of cannabis in Germany and reduced stigma among healthcare professionals considering cannabis prescribing.
Infarmed continued its GMP inspection programme for licensed cannabis manufacturers in July. Portugal's role as a primary EU GMP cannabis manufacturing hub for the German market continues to grow, with several facilities reporting significant capacity expansion to meet increasing demand.
Infarmed has signalled continued focus on contamination control strategy documentation as an inspection priority following the 2022 Annex 1 revision. Operators in Portugal without a current, Annex 1 (2022) compliant CCS should prioritise this ahead of their next inspection.
France's extended medical cannabis pilot continues to enrol patients. ANSM published updated guidance in July on the prescribing pathway within the pilot programme and the documentation requirements for prescribing physicians. The legislative process for a full national programme continues through the French parliament.
The MHRA continued its review of import licence applications for pharmaceutical cannabis products from non-UK manufacturers. Post-Brexit, the MHRA conducts independent assessment of manufacturing compliance for products not previously assessed by a recognised regulatory authority. Manufacturers supplying the UK market should allow additional time for MHRA review compared to EU regulatory processes.
Several enforcement actions against non-compliant cannabis products were reported across European markets in July, primarily relating to:
These enforcement actions underscore the importance of regulatory compliance across all aspects of cannabis product marketing and supply — not only manufacturing GMP compliance.
Watch for: EMA HMPC meeting outcomes; BfArM updated guidance on import permit applications; Infarmed inspection programme announcements; French pilot programme legislative developments; and the next edition of ECI Regulatory Watch.
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