Germany

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