Our network of professionals in 14 European countries will always work hard to develop innovative, tailored, and cost-effective strategies based on your needs.


A Wholesale Distribution License (WDL) is needed for marketing authorisation holders, wholesalers, co-distributors. Marketing authorisation holders and co-distributors additionally have to notify as pharmazeutischer Unternehmer (pharmaceutical entrepreneur).

The decision on granting the WDL is taken by the competent federal state authority of the region where the company has established its offices. The WDL will be granted based on an application and an inspection by the authority. Licenses needed and requirements to receive those licenses differ depending on the specific situation and location. However, some general requirements are summarized below:

  • Responsible Person for Wholesaling with expert knowledge
  • Quality Management System
  • Technical Quality Agreements

Our QM Systems & Licenses team at Dr. Regenold GmbH will:

  • Establish a complete Quality System or adapt your existing system
  • Compile and submit application for the required licenses including follow-up with the authorities
  • Support during implementation of your system and inspection


Dr. Regenold GmbH
Zöllinplatz 4
D-79410 Badenweiler

+49 7632 82 26-510

“Achieving an optimal quality system, which fulfills EU country specific requirements and fits to your company internal strategy and processes, is mandatory for successfully achieving the required licenses and enhancing a high internal compliance”
Sonja Rüdele, Head of QM Systems & Licenses