Our quality promise
How safe are medical products from the EU?
Imported medical products are the manufacturer’s original products approved in another member state of the EU, manufactured according to uniform statutory requirements and quality standards, if need be only with different packaging for the country.
Subject to regulatory controls, we import them into Germany as a pharmaceutical wholesaler. We are registered with the national authorities as a parallel importer. In Germany, the products are repackaged and labelled according to all statutory regulations. They receive our own pharmaceutical central number (PZN) and labels in German. The safety of EU medical products is guaranteed at all times.
How is quality guaranteed?
As original products with the CE marking required by law, EU medical products are subject to the manufacturer’s strict quality controls and those of B2B MEDICAL. In their use and therapeutic effect, they are identical to the original product. The quality of parallel imported medical products is ensured at all times.
Our quality assurance:
The quality and safety of all our products for the healthcare sector are our top priority.
- We work together with reliable suppliers which we have known personally for many years, and have a well-developed European-wide network of respectable wholesale partners in the healthcare sector.
- New suppliers undergo a comprehensive supplier qualification process before they can be listed with us.
- Our quality management system, which defines all processes that we continuously monitor, is regularly verified by the supervisory authorities according to the good manufacturing practices (GMP) and good distribution practices (GDP).
- Our pharmacist and Quality Control Manager is well versed in all statutory requirements of the healthcare sector and scrupulously makes sure they are implemented.
- We have both a pharmaceutical manufacturing authorisation in accordance with Section 13 Paragraph 1 and Section 72 of the German Pharmaceutical Law (AMG) and also through a pharmaceutical wholesale authorisation in accordance with Section 52a of the AMG.