Apply for a license for the wholesale of medicinal products

• You can submit your application for a license to engage in the wholesale distribution of pharmaceuticals in writing or electronically.
• Once you have submitted the application and all required documents are complete, the competent authority will review whether you meet all the requirements.
• If you meet all the requirements, the competent authority will conduct the legally required acceptance inspection. Once the inspection is complete and any identified deficiencies have been corrected, you will receive the license you applied for.
• You may not begin operations until you have received the license.

More information

You do not need a license to engage in the wholesale distribution of drugs for:

• the distribution of ready-to-use medicinal products approved for sale outside of pharmacies, which are
  
  • medicinal waters and their salts in their natural proportions, or imitations thereof, and
  • may be sold in the travel trade.
• Activities carried out as a pharmacy within the scope of normal pharmacy operations. These include, among other things:
  
  • the delivery of medicinal products to physicians (for use during office hours) or hospitals (for clinical care) within Germany.
  • Returns to pharmaceutical wholesalers, returns to wholesalers as part of a pharmacy’s regular inventory clearance.
  • The procurement of medications through purchasing cooperatives.
  • The transfer of medications within a chain of pharmacies.

Department 32 of the Senatorial Authority for Health, Women, and Consumer Protection (tierarzneimittel@gesundheit.bremen.de) is responsible for applications for a license to wholesale veterinary drugs in the state of Bremen.

• In connection with the following information, please refer to the information sheet for the granting of the wholesale permit under "Further information".
  

  When applying for a wholesale license, you must:
  

  • specify the particular business premises, as well as the activities and medicinal products for which the license is to be granted
  • Submit evidence that you have suitable and adequate premises, facilities, and equipment for:
    
    • proper storage
    • proper distribution
    • where applicable, the proper repackaging, packaging, and labeling of medicinal products
  • appoint a responsible person who possesses the necessary expertise
  • include a statement in which you undertake to comply with the regulations applicable to the proper operation of a wholesale distribution business.

Simplified online form
You can use this form to upload applications and supporting documents for an existing application. You can also ask questions about your application.

123,00 EUR bis 2.000,00 EUR GDP Authorization
522,00 EUR bis 10.440,00 EUR Acceptance inspection

What deadlines must be paid attention to?

You may not start wholesaling before the permit has been granted. The competent authority must make a decision on the application for a permit within a period of three months.

How long does it take to process

The competent authority will generally make a decision on the application for a permit within three months of receiving the complete documentation. If the competent authority requests additional information from you regarding the requirements, it will suspend the aforementioned deadline until the required information is provided.

• § 52a Arzneimittelgesetz (AMG)
• § 4 Absatz 22 Arzneimittelgesetz (AMG)
• Gesundheits-Kostenverordnung (GesundKostV)

• Merkblatt Antrag auf Erteilung der Großhandelserlaubnis