Permission for wholesale trade in medicinal products Issuance

Procedure

You can submit the application for a wholesale authorization according to § 52a AMG in writing or electronically.

Once you have submitted the application and all documents are complete, the competent authority will check whether you meet all the requirements.

If you meet all requirements, the legally required acceptance inspection by the competent authority will follow. You will then receive the permit you applied for.

You may not start work until you have received the permit.

Legal bases

• § 52a Arzneimittelgesetz (AMG)

More information

Exempt from the licensing requirement are finished medicinal products released for circulation outside pharmacies, which may be dispensed in itinerant trade (cf. Section 52a (1) of the German Medicines Act).

Responsible for applications for permission to wholesale veterinary medicinal products in the state of Bremen is the department 42 of the senatorial authority for health, women and consumer protection.According to § 52 a Abs. 7 AMG, no permission is required for wholesale activities that are carried out within the framework of normal pharmacy operations. These include:

• The supply of pharmaceuticals to physicians (consultation hour supplies) or hospitals (hospital supplies according to § 14 ApoG) within Germany,
• returns to pharmaceutical wholesalers, returns to wholesalers as part of regular stock clearing by the pharmacy,
• the purchase of medicinal products within the framework of purchasing syndicates or the passing on of medicinal products to other pharmacies, provided that no profit is to be made in the process, and
• the passing on of medicinal products within a branch network.