Apply for a license to wholesale medicines

Prerequisites

The requirements result from § 52a AMG:
With the application, the applicant has

• to name the specific business premises as well as the activities and the medicinal products for which the license is to be granted,
• Submit evidence that he*she has suitable and sufficient premises, facilities and facilities to ensure proper storage and distribution and, where provided, proper decanting, packaging and labeling of medicinal products,
• to appoint a responsible person who has the expertise required to carry out the activity, and

to include a declaration in which he undertakes in writing to comply with the regulations applicable to the proper operation of a wholesale trade

Documents required

• According to the GmbH law, the registration with the commercial register must include the wholesale license if the object of the company requires the license. In the event that the company has not yet been entered in the commercial register, the authority can issue a clearance certificate. On this basis, to which the registry court is bound, the entry in the commercial register can take place.
• For companies with headquarters in Hamburg:
  • if kept in the commercial register, no excerpt is required; otherwise business registration.
• For companies with headquarters outside of Hamburg:
  • Current (not older than 3 months) certified copy of the extract from the commercial register (if necessary also of the general partner)
  • if the business premises in Hamburg are not entered in the commercial register, additional proof of business registration.
• Submission of floor plans of the rooms (in duplicate) where medicines are stored and distributed.
  • The floor plans should generally be presented on a scale of 1: 100 and contain the designation of the operating rooms and m². In addition, essential furnishings and the individual storage areas (quarantine storage, locked storage) should be marked.
• Declaration by the applicant (managing director/board member) in which he undertakes to observe/comply with the regulations applicable to the proper operation of the wholesale trade.
• Police clearance certificate from the applicant (managing director/board member) of document type 0 for submission to an authority in accordance with Section 30 (5) BZRGU (not older than 3 months) and a declaration by the applicant (managing director / Executive Board) that there are currently no criminal proceedings against him (please state company name, file number and purpose when applying.)
• Evidence of the qualifications of the responsible person (professional career, certificates) based on certified copies
• Police clearance certificate of the responsible person (document type 0 for submission to an authority according to § 30 Para. 5 BZRG, not older than 3 months) as well as a declaration from the responsible person that there are currently no criminal proceedings against them.
• (Please state company name, file number and purpose when applying.)
• Personal statement from the responsible person that they will inform the competent authority immediately if there are any changes in their function as responsible person (changed area of responsibility, departure from wholesale operations).
• organization chart
• List of Suppliers
• List of customers/pharmaceutical recipients (except domestic pharmacies)
• Table of contents of your quality assurance system (e.g. list of procedural instructions)

Procedural instructions according to § 1a AM-HandelsV

Please note

There are the following hints:
The authority for justice and consumer protection is responsible for pharmacies that want to operate as pharmaceutical wholesalers and other companies.
Excluded from the license requirement are the finished medicinal products released for sale outside of pharmacies, which may be dispensed in itinerant trades (cf. Section 52a Paragraph 1 of the Medicines Act).
According to § 52 a paragraph 7 AMG, no permit is required for wholesale activities that are carried out as part of normal pharmacy operations. These include:

• the delivery of medicines to doctors (need for consultation hours) or hospitals (hospital care according to § 14 ApoG) within Germany,
• Returns to pharmaceutical wholesalers, returns to wholesalers as part of a regular warehouse clean-up by the pharmacy,
• the procurement of medicines within the framework of purchasing groups or passing them on to other pharmacies, provided that no profit is to be made and
• the transfer of medicines within a branch network.

Deadlines

You are not allowed to start wholesale business before permission is granted. In principle, the competent authority must make a decision on the application for the grant of a license within a period of three months.

Procedure

You can apply for a wholesale license in accordance with § 52a AMG in writing or electronically.
Once you have submitted the application and all the documents are complete, the competent authority will check whether you meet all the requirements.
If you meet all the requirements, the legally required acceptance inspection by the competent authority follows. You will then receive the requested permit.
You may not start the activity until you have received permission.

Processing time

If the documents are complete, your application will be processed promptly.

Fees

No

Legal remedies

Administrative lawsuit

Legal basis

§ 52a Medicines Act (AMG)

If you want to operate a wholesale business in pharmaceuticals, you need permission from the responsible authority. For details, click here.