Euro Biomedico GmbH
Drug Brokers · Wiesbaden
Euro Biomedico GmbH is a drug broker based in Wiesbaden, Germany.
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Euro Biomedico GmbH Address & Contact
Overview of Euro Biomedico GmbH
Euro Biomedico GmbH was founded in 2010 and has since established itself as a significant player in the field of pharmaceutical intermediaries. The company is based in Wiesbaden, Hesse, and specializes in the distribution and mediation of biotechnology medicines and biologics. In particular, the knowledge in the area of biopharmaceuticals allows Euro Biomedico to bridge the gap between manufacturers and consumers, thus providing valuable resources in the healthcare sector.
Services and Products
Euro Biomedico offers targeted mediation of biologics, biosimilars, and biotechnologically manufactured medicines. Special attention is paid to registration as a pharmaceutical intermediary according to § 52b of the German Medicines Act (AMG). This registration is an important legal requirement that enables the company to operate safely and efficiently in the German healthcare market. In addition to pure mediation, Euro Biomedico also offers comprehensive consulting services focused on the procurement and distribution of biopharmaceuticals to hospital pharmacies. The company supports pharmacists and medical institutions in optimizing access to necessary medicines and ensuring supply security.
Regulatory Classification and Quality Assurance
Euro Biomedico GmbH is subject to the strict provisions of German medicinal law, which clearly regulates the safety and quality of medicines. The company monitors and documents the entire supply chain to ensure continuous quality assurance. Furthermore, Euro Biomedico works closely with manufacturers to ensure that all products comply with the necessary guidelines and are approved throughout the EU. The regulatory authorities in Germany continuously monitor compliance with these requirements, which already demonstrates the high trust in the services of Euro Biomedico.
Characteristics of the Company
An outstanding feature of Euro Biomedico GmbH is the close cooperation with innovative biotechnology companies and research institutions. These networks enable Euro Biomedico to stay constantly informed about the latest developments in biopharmaceuticals and to integrate this information into their services. The company philosophy is based on the belief that the future of medicine lies in biotechnological developments, which is why the company also plays an active role in promoting new therapies and medications.
Importance for the Region
Euro Biomedico GmbH significantly contributes to the economic development of Wiesbaden and the surrounding Hesse region. By mediating innovative medicines, the company not only promotes healthcare locally but also creates jobs and contributes to the training of professionals in the biomedical sector. Wiesbaden benefits from its location due to proximity to other important players in the pharmaceutical and biotechnology industries, facilitating exchange and collaboration in this sector.
The positioning of Euro Biomedico in Wiesbaden is particularly favorable, as the region is part of the dynamic Rhine-Main metropolitan area. This region is not only an economic location but also a center for research and development in healthcare, which offers Euro Biomedico numerous opportunities for partnerships and knowledge exchange.
Other pharmaceutical intermediaries: Overview of Pharmaceutical Intermediaries | Pharmaceutical Wholesaling | Pharmaceutical Companies
Frequently asked questions about Euro Biomedico GmbH
What does Euro Biomedico GmbH do?
Euro Biomedico ist ein Exporteur und Distributor europäischer Arzneimittel und Medizingeräte mit Sitz in Wiesbaden. Das Unternehmen vertreibt EU-Pharmazeutika und medizinische Ausrüstung in internationale Märkte.
Was ist der Medizintourismus-Service von Euro Biomedico?
Euro Biomedico vermittelt medizinische Behandlungen in Deutschland für internationale Patienten: Terminbuchung, Transfer, Visadokumentation und umfassende Betreuung für Operationen und Facharzttermine.
Welche Produkte exportiert Euro Biomedico?
Euro Biomedico exportiert europäische Arzneimittel sowie Krankenhaus- und Laborausrüstungen, Medizingeräte und Verbrauchsmaterialien in internationale Märkte.
Drug Brokers in Germany
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About Drug Brokers
A medicine broker (Arzneimittelvermittler) is a business that arranges the purchase or sale of human medicines between manufacturers, wholesalers and buyers, acting as an intermediary without ever taking physical possession of or legal title to the products. This role is formally defined under Section 4(22b) of the AMG (German Medicinal Products Act). Medicine brokers play a role in international parallel trade and in secondary supply chains, but their activities are subject to strict legal requirements to prevent counterfeit medicines from entering the legitimate supply chain. In Germany, anyone wishing to act as a medicine broker must register with the competent authority of the relevant German federal state under Section 52b AMG. Registration requires a permanent business address in Germany or another EU member state, a designated responsible person, and a fully documented quality management system that meets the requirements of the EU Good Distribution Practice (GDP) guidelines for medicine brokers. Failure to register or to maintain the required quality system constitutes a criminal offence under German pharmaceutical law. The registration system ensures traceability and accountability throughout the supply chain. Medicine brokers must not procure medicines from unlicensed sources or supply non-authorised products. The GDP requirements specific to brokers include record keeping, complaint handling, recall procedures and counterfeiting detection. This directory lists all medicine brokers registered with German authorities under Section 52b AMG, with addresses and contact details.
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.
What does a medicine broker do?
A medicine broker, as defined under Section 4(22b) of the AMG (German Medicinal Products Act), arranges transactions in human medicines without taking ownership of the products or physically handling them. Brokers must be registered with the responsible authority and maintain a quality management system.
What registration does a medicine broker need?
Medicine brokers must register under Section 52b AMG with the responsible state authority. Requirements include an official business address in Germany and a documented quality system meeting GDP (Good Distribution Practice) standards.
Where can I find registered medicine brokers in Germany?
The competent state pharmaceutical supervisory authority in each federal state maintains a register of brokers registered under Section 52b AMG. Sanoliste provides a searchable overview of registered medicine brokers across Germany with contact details and addresses.
Why are medicine brokers regulated in Germany?
Regulation of medicine brokers in Germany is primarily aimed at preventing counterfeit and substandard medicines from entering the legitimate pharmaceutical supply chain. By requiring registration and a documented GDP quality system, authorities can trace the origin and movement of medicines arranged by brokers. This protects patients and ensures that only authorised medicines from authorised sources reach pharmacies and hospitals.
What are the GDP requirements for medicine brokers in Germany?
Under EU GDP guidelines (2013/C 343/01), medicine brokers must maintain a quality system that covers written procedures, complaint handling, product recall procedures, record keeping and measures to detect falsified medicines. They must only deal with manufacturers and wholesalers that hold the appropriate authorisations. These requirements apply equally to brokers registered in Germany under Section 52b AMG.
How does medicine brokering differ from pharmaceutical wholesale in Germany?
The key difference is physical possession. A pharmaceutical wholesaler (Pharmagrosshandel) physically stores and ships medicinal products and requires a wholesale dealer authorisation under Section 52a AMG. A medicine broker (Arzneimittelvermittler) never takes possession of the goods; it only acts as an intermediary arranging deals between other parties. Brokers require registration under Section 52b AMG rather than a full wholesale authorisation.