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D. H. Beteiligungs GmbH Address & Contact
D. H. Beteiligungs GmbH Overview
D. H. Beteiligungs GmbH is a pharmaceutical intermediary based in Rastede, Lower Saxony, specializing in coordinating pharmaceutical trade transactions. As a holding company in the pharmaceutical trade, the company operates not only on a national level but also has connections to international manufacturers and customers. With a clearly defined focus on mediating between pharmaceutical manufacturers and buyers, D. H. Beteiligungs GmbH plays an essential role in the healthcare sector. In the multitude of services offered, the company emphasizes the highest standards and compliance with legal requirements.
Services and Products
The core competency of D. H. Beteiligungs GmbH lies in the efficient and reliable mediation of pharmaceuticals. The company coordinates pharmaceutical trade transactions without operating its own warehousing. As a pharmaceutical intermediary under § 52b AMG, the company is committed to adhering to specific standards. This particularly includes Good Distribution Practice (GDP), which ensures that the quality of pharmaceuticals is maintained throughout the distribution process.
- Customer Consultation: The company offers comprehensive consulting services to help its clients select the right products for their specific needs.
- Market Access: D. H. Beteiligungs GmbH supports manufacturers in accessing the German market and promotes compliance with regulatory requirements.
- Logistics Solutions: Although it does not operate its own warehouses, the company works closely with external logistics providers to ensure the smooth distribution of pharmaceuticals.
These services are particularly important in a constantly changing regulatory environment, where compliance with regulations is crucial for business success. With a dedicated team of professionals, D. H. Beteiligungs GmbH is focused on ensuring the highest standards in pharmaceutical mediation.
Regulatory Classification
D. H. Beteiligungs GmbH is registered as a pharmaceutical intermediary according to the Pharmaceutical Act (§ 52b AMG). This certification underscores the reliability and responsibility of the company in handling pharmaceuticals. In connection with the requirements of GDP, all activities of the company are regularly reviewed to guarantee the integrity and quality of the mediated products. The legally anchored requirements ensure that the entire distribution process remains transparent and traceable, which is not only in line with the company's philosophy but also crucial for patient safety.
Regional Significance
Rastede, located in the Ammerland district, has developed into an important hub for the healthcare economy in Lower Saxony. Its proximity to the city of Oldenburg, which has a clinic and numerous healthcare providers, enhances the local relevance of D. H. Beteiligungs GmbH. By collaborating with regional healthcare players, the company contributes to improving access to high-quality pharmaceuticals and promotes close networking between manufacturers, pharmacies, and healthcare institutions. Additionally, the company benefits from the dynamic economy of the region, which is continuously evolving and focused on innovations.
Special Features of D. H. Beteiligungs GmbH
One of the particular strengths of D. H. Beteiligungs GmbH is the high flexibility it offers compared to companies with their own stock. This structure allows for faster adaptation to market changes and more efficient order processing. Furthermore, the company is continuously interested in further developing its services and systems to meet the changing demands of the industry.
Innovations and modern technologies play a crucial role in the business processes of D. H. Beteiligungs GmbH. By employing digital tools, not only is the efficiency of internal processes improved, but communication with partners and customers is also optimized. In this way, the company actively contributes to shaping the pharmaceutical supply in Germany and establishes itself in an increasingly competitive market.
Other Pharmaceutical Intermediaries: Overview of Pharmaceutical Intermediaries | Pharmaceutical Wholesale | Pharmaceutical Companies
Frequently asked questions about D. H. Beteiligungs GmbH
What is D. H. Beteiligungs GmbH?
D. H. Beteiligungs GmbH is a licensed pharmaceutical broker based in Rastede. Pharmaceutical brokers trade in their own name without taking ownership of the medicines and must be registered with the competent authority.
What does a pharmaceutical broker do?
A pharmaceutical broker acts as an intermediary between the manufacturer and buyer of medicines without being physically involved in the delivery process. The activity requires a licence under § 52c AMG and is subject to GDP requirements.
How is D. H. Beteiligungs GmbH regulated?
As a pharmaceutical broker, D. H. Beteiligungs GmbH is registered with the competent German authority and is subject to the requirements of the Medicines Act (AMG) and the EU Good Distribution Practice (GDP) guidelines.
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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.