Hofmann und Sommer GmbH & Co. KG

Medicine Brokering in Germany: Legal Framework

Medicine brokering is a regulated activity in Germany and across the European Union, governed by the EU Falsified Medicines Directive (2011/62/EU) and its implementing measures, transposed into German law through amendments to the AMG. The formal definition of a medicine broker (Arzneimittelvermittler) is set out in Section 4(22b) AMG: a natural or legal person who arranges transactions involving medicinal products for human use between manufacturers, wholesalers and buyers, without themselves acquiring or supplying the products and without taking physical possession of them. This intermediary role distinguishes brokers from wholesalers. The registration requirement under Section 52b AMG was introduced specifically to increase transparency and traceability in the medicine supply chain, after investigations revealed that unlicensed brokers had been involved in the entry of substandard or falsified medicines into European supply chains. Germany's registration system requires brokers to notify the competent state authority before commencing operations and to maintain their registration as long as they are active.

GDP Quality System Requirements for Medicine Brokers

Although medicine brokers do not physically handle medicines, they are still required to operate a documented quality management system (QMS) under the EU GDP guidelines for brokers (2013/C 343/01, Part III). The QMS must cover several key areas: written procedures (SOPs) for all brokering activities, a system for verifying that all counterpart manufacturers and wholesalers hold the required licences, a complaints handling system for quality-related issues, a product recall procedure that can be activated even though the broker did not physically move the goods, record keeping for a minimum of five years for all brokered transactions, and procedures for detecting and reporting suspected falsified medicines to the competent authority. Brokers must not source from or supply to unlicensed parties. Regular self-inspections and, where relevant, external audits ensure the QMS remains effective. The competent state authority may inspect a broker's QMS as part of its oversight activities.

Medicine Brokering and Parallel Trade in the EU

Medicine brokering is closely associated with parallel trade (Parallelhandel) in the EU pharmaceutical market. Parallel trade occurs when an authorised medicine is purchased in an EU member state where its price is lower and resold in another member state where the price is higher, exploiting price differentials across the single market. Germany, as a large market with relatively higher medicine prices than some southern and eastern European member states, is a significant destination for parallel-traded medicines. Parallel importers must obtain a parallel import permit from BfArM or PEI for each product, ensuring the imported medicine is equivalent to the authorised German version. Medicine brokers can play a role in arranging these cross-border transactions. However, all parties in the parallel trade supply chain, including brokers, must comply with applicable GDP and registration requirements. The Falsified Medicines Directive's safety features (tamper-evident packaging and unique identifiers under the EU Falsified Medicines Verification System, EMVS) apply to all prescription medicines circulating in Germany.

Compliance and GDP Requirements for Brokers

Pharmaceutical brokers remain under strict regulatory oversight despite not handling products physically. A broker's GDP quality system must include procedures for order processing, supplier qualification, complaints management, recall management and self-inspections. All brokered medicinal products must originate from legal, officially approved sources; transaction documentation must be kept comprehensively and retained for at least five years. Suspected falsified medicines must be reported to the competent authority. The European Commission defined clear requirements for brokers without product ownership in GDP Guidelines 2013/C 343/01. Regular self-inspections and the designation of a Responsible Person (RP) are mandatory. Violations can result in deregistration and criminal consequences under the Medicines Act. The Sanoliste directory only lists brokers who were registered in accordance with Section 52b AMG at the time of their entry.