BTC - GmbH
Drug Brokers · Siek
BTC - GmbH is a drug broker based in Siek, Germany.
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BTC - GmbH – Address & Contact
BTC - GmbH Overview
BTC - GmbH is a registered pharmaceutical broker in accordance with Section 52b AMG based in Siek, Hamburg. The company brokers transactions for human medicines without physically handling the goods.
Tätigkeitsfeld & Registrierung
BTC - GmbH is registered with the responsible state authority in accordance with Section 52b AMG and is subject to the requirements of Good Sales Practice (GDP). The company mediates transactions between manufacturers, wholesalers and buyers.
Location & Contact
BTC - GmbH can be reached at the following address: Ohlenstücken 7, 22962 Siek – Phone: 069153228470. For current information and enquiries, please contact the company directly.
More information: Arzneimittelvermittler in Hamburg or all Arzneimittelvermittler in Germany on Sanoliste.
Arzneimittelvermittlung nach § 52b AMG
Medicinal brokers such as BTC - GmbH mediate the purchase and sale of human medicinal products without taking physical possession of the goods themselves. The activity is regulated in Germany according to Section 52b of the Medicines Act (AMG). Intermediaries must be registered with the relevant state authority and ensure compliance with Good Sales Practices (GDP).
Regulatorische Anforderungen
BTC - GmbH is subject to strict requirements: registration with the BfArM, compliance with the GDP guidelines, documented qualification of business partners (manufacturers, wholesalers, pharmacies) and complete traceability of all mediated transactions. Unlike wholesalers, intermediaries do not need a wholesale license, but they must maintain a quality assurance system and carry out self-inspections.
Marktrolle & Bedeutung
Drug intermediaries play an important role in the European pharmaceutical market, particularly in cross-border trade. BTC - GmbH in Siek acts as an interface between manufacturers and buyers and enables efficient pharmaceutical trading. Intermediary activity is becoming increasingly important as global supply chains become more complex.
Frequently asked questions about BTC - GmbH
Was ist BTC - GmbH?
BTC - GmbH ist ein zugelassener Arzneimittelvermittler mit Sitz in Siek. Arzneimittelvermittler handeln im eigenen Namen, ohne Eigentümer der Arzneimittel zu werden, und sind nach § 52c AMG registrierungspflichtig.
What does ein Arzneimittelvermittler do?
A pharmaceutical broker acts as an intermediary between the manufacturer and the buyer of medicines without being physically involved in the delivery process. The activity is subject to GDP requirements and regulatory supervision.
Wie ist BTC - GmbH reguliert?
Als Arzneimittelvermittler ist BTC - GmbH bei der zuständigen deutschen Behörde registriert und unterliegt den Anforderungen des AMG sowie den EU-GDP-Leitlinien.
How does a pharmaceutical broker differ from a wholesaler?
The key difference is that a pharmaceutical broker never physically handles medicines but exclusively brokers transactions between buyers and sellers. A wholesaler, on the other hand, takes physical possession of the goods, stores them and distributes them. Accordingly, the broker does not require a wholesale licence but rather a registration pursuant to Section 52b of the German Medicines Act (AMG).
What does GDP mean for pharmaceutical brokers?
GDP (Good Distribution Practice) is the standard for good distribution practice \u2013 a quality standard for all participants in the pharmaceutical supply chain. Brokers such as BTC - GmbH must operate a GDP-compliant quality assurance system, qualify their business partners and maintain documented traceability of all transactions.
Must a pharmaceutical broker be registered with the BfArM?
Yes, registration as a pharmaceutical broker pursuant to Section 52b of the German Medicines Act (AMG) is mandatory. Registration is carried out with the competent regional authority and is reported to the BfArM. Without valid registration, brokering activity is illegal.
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