Kehrtwende bei Krypto-Besteuerung in Deutschland in Sicht
September 10, 2026
Regulatory excellence at the heart of the Mediterranean.
The path from initial development to market authorization is highly complex. We navigate life sciences and pharmaceutical enterprises through stringent EU regulatory frameworks and Maltese legislation, bringing your innovations to market safely and efficiently.
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1. Regulatory Strategy & Licensing
Advisory on obtaining manufacturing authorizations (GMP – Good Manufacturing Practice). Support throughout certification under MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation). Specialized legal counsel in the sector of medicinal cannabis (production, research, and export).
2. IP Protection & R&D Structuring
Securing patents and trademark rights for pharmaceutical formulations. Legal structuring of collaborative agreements with research institutions. Leveraging Research & Development incentives (R&D Tax Credits) in Malta.
3. Market Access & Distribution
Drafting EU-wide distribution and licensing agreements (GDP – Good Distribution Practice). Advisory on product liability within an international cross-border context. Assistance with import and export authorizations for non-EU third countries.
1. Why is Malta considered a highly attractive gateway location for the international pharmaceutical industry?
Answer: Malta combines the most rigorous EU standards with premier logistical and fiscal frameworks. As a full EU member state, all approvals, licenses, and certifications issued by the Malta Medicines Authority (MMA)Malta Medicines Authorityare fully valid across the entire European Economic Area (EEA) as well as in numerous third countries covered by Mutual Recognition Agreements (MRAs).
Pharmaceutical companies benefit from fast-track authorization procedures, a highly skilled workforce, and the opportunity to optimize corporate profits from manufacturing and global export down to an effective tax rate of approximately 5% through established Maltese holding structures (via the proven 6/7 tax refund mechanism on active trading income). 5 % Körperschaftsteuer zu optimieren.
2. What role does the EU-GMP certificate issued by the Malta Medicines Authority play?
Answer: The EU-GMP certificate (Good Manufacturing Practiceof the Malta Medicines Authority that is a hallmark of quality for pharmaceutical manufacturingBatch Releaseand quality control.
The Maltese authority enjoys an outstanding international reputation for its efficiency in inspecting production facilities and handling re-licensing procedures. Companies importing active pharmaceutical ingredients (APIs) or finished dosage forms into Europe frequently use Malta as a central EU import and testing hub, as batch certification and release by aQualified Person / QPcan be executed with full regulatory certainty for the entire EU Single Market.
3. How are the production and export of medicinal cannabis legally regulated in Malta?
Answer: As early as 2018, Malta established one of the world's most progressive legal frameworks for medical cannabis (Production of Cannabis for Medicinal and Research Purposes Act).
Requirements: Companies must undergo a comprehensive licensing procedure, demonstrate compliance with the most stringent EU-GMP standards, and guarantee the physical security of their facilities.
Legal Distinction: The commercial production of medicinal cannabis is strictly separated from the non-profit associations for adult use, which are regulated by the dedicated cannabis authority (ARUC – Authority for the Responsible Use of Cannabis). ARUC reguliert werden.
4. What must medical technology (MedTech) manufacturers consider under the EU Regulations MDR and IVDR?
Answer: The European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) place enormous demands on manufacturers, importers, and distributors. Anyone seeking to place medical devices on the EU market requires a seamless quality management system (ISO 13485) as well as robust, airtight clinical evaluations.
We assist MedTech companies with establishing their legal presence as an official EU Authorised RepresentativeAuthorized Representativewith the drafting ofcontracts with notified bodiesNotified Bodiesand securing distribution agreements within the EU Single Market.
5. How are research and development (R&D) expenditures and pharmaceutical patents fiscally incentivized?
Answer: Life sciences and pharmaceutical companies in Malta can benefit from government incentive programs. Through the economic development agency, Malta Enterprise Malta Enterprise soft loans, investment grants, and tax credits (Tax Credits) are available for research and development.
Additionally, for patented pharmaceuticals and copyrighted biopharmaceutical developments, the Patent Box Regime: Qualified IP income can thereby be taxed at an effective rate of up to 1,75 % .
6. How does the law firm assist pharmaceutical and biotech companies with establishing their operations in Malta?
Answer: Establishing pharmaceutical manufacturing operations or an active substance storage facility is a highly complex, multidisciplinary undertaking. Our comprehensive full-service advisory approach encompasses:
Regulatory Licensing Management: Representation before the Malta Medicines Authority and Malta Enterprise to obtain all necessary manufacturing and wholesale distribution authorizations (WDAsWDA – Wholesale Distribution Authorisation).
Real Estate and Infrastructure Agreements: Legal representation and counsel in leasing or acquiring specialized industrial real estate through Malta.
Corporate & Financial Structuring: Setting up holding and operating companies, preparing banking onboarding for pharmaceutical transactions, and securing formal R&D grant and incentive approvals.
Incorporating a company in Malta is merely the initial step for pharmaceutical enterprises. The true challenge lies in maintaining strict GMP and GDP compliance under the scrutiny of the Malta Medicines Authority. At Kresse Law, we understand the critical nature of your operational processes. We structure robust, legally compliant operational entities designed to meet the rigorous demands of EU health and life sciences legislation in 2026. We safeguard your innovative power and commercial success through uncompromised legal precision.
We support you in the medical and pharmaceutical sectors with legally sound planning, precise execution, and dedicated personal counsel in Malta.
