Malta

Medical cannabis legal since 2018 under the Medicines Act (Medicines Authority oversight). Industrial and export cannabis regulated by MMCA since 2018. Adult recreational use also legal since 2021 under separate framework. Malta was an EU pioneer on cannabis policy.

Malta's MMCA framework enables large-scale cannabis cultivation and manufacturing specifically for EU export. Maltese EU-GMP Part I certificates are directly valid across the EU. Malta offers favorable conditions for EU cannabis manufacturers targeting the German, Dutch, and Czech markets.

Malta's domestic medical cannabis market is small — population ~530,000. Domestic patient prescribing via specialist prescription. Medicines Authority manages import licenses for domestically used products. The MMCA export business is the primary commercial opportunity.

Malta International Airport (MLA) is the only significant commercial entry point for cannabis imports — Malta is an island. All import shipments arrive by air. Sea freight is possible via Valletta port for bulk shipments.

Some international cannabis companies use Malta's MMCA framework as an EU licensing and manufacturing platform, obtaining EU-GMP Part I in Malta and then exporting to Germany, Netherlands, and other EU markets. Malta's regulatory body is competent and English-speaking.

Per-shipment import license from Medicines Authority for medical cannabis products. EU-GMP Part I and GACP certificates required. Processing: approximately 2–4 weeks. One of the faster EU import processes.

MMCA-licensed Maltese manufacturers may export with MMCA export authorization per shipment. Destination import authorization must be obtained first. EU-GMP Part I certificate from Maltese MMCA-licensed site is directly valid in all EU member states.

All air imports and exports via MLA. GDP-compliant pharmaceutical handling available. Limited by airport size — large volume shipments may require multiple consolidations or sea freight via Valletta port.

Medicines Authority of Malta conducts EU-GMP inspections and issues EU-GMP Part I certificates. These are accepted directly by all EU member state authorities (BfArM, CCBM, SÚKL etc.) without further inspection.

MMCA sets quality standards for industrial cannabis export. Manufacturers must hold EU-GMP Part I from Medicines Authority for finished product export. GACP certification required for all cultivation sites.

All batches for EU market must be certified by an EU Qualified Person. For Maltese manufacturers, the QP may be employed at the Maltese site or at the EU importing entity.

ISO 17065-accredited certification required. Current certificate required for both import licenses and MMCA export authorizations. Chain of custody from cultivation to manufacturing must be documented.