Apply for a license for the wholesale of medicinal products

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.

More information

Excluded from the authorization requirement are finished medicinal products released for sale outside pharmacies, which may be dispensed in the travel trade (see Section 52a (1) of the German Medicinal Products Act).

Department 32 of the senatorial authority for health, women and consumer protection (tierarzneimittel@gesundheit.bremen.de) is responsible for applications for authorization to wholesale veterinary medicinal products in the state of Bremen.

According to § 52 a para. 7 AMG, no license is required for wholesale activities that are carried out as part of normal pharmacy operations. These include, among others

• the supply of medicinal products to doctors (consultation supplies) or hospitals (hospital supplies in accordance with Section 14 ApoG) within Germany,
• returns to pharmaceutical wholesalers, returns to wholesalers as part of the pharmacy's regular stock clearance,
• the purchase of medicinal products within the framework of purchasing groups
  and
• the transfer of medicinal products within a branch network.

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

  Application:
  

  • Informal application stating the name, address, telephone number, email address of the person applying for
  • Extract of the company's entry in the commercial register (not older than 3 months)

  Place of business:
  

  • Exact name of the business premises with street, house number for which the permit
    is to be issued, as well as details
    
    • the company headquarters
    • the storage site (if different)
  • Submission of floor plans in electronic form of the rooms in which medicinal products
    are stored and distributed. As a rule, the floor plans should be submitted at a scale of 1:100
    and should include the name of the operating rooms and an indication of the m²
    . Furthermore, essential furnishings as well as the individual
    storage areas (quarantine storage, locked storage) must be marked.

  Personnel:
  

  • Organizational chart
  • Police clearance certificate of the applicant of document type 0 for submission to an authority (not older than 3 months). Please state the
    purpose of use "Wholesale permit".
  • Naming of the responsible person in accordance with Section 52a (2) No. 3 of the German Medicines Act (AMG) with the following details: Date of birth, place of birth, address of current
    residence, direct extension at which the responsible person can be reached.
  • Proof of the responsible person's qualifications: curriculum vitae, degree certificate, diploma, state examination or similar on the basis of a certified copy
  • Police clearance certificate of the responsible person (document type 0 for submission to an authority, not older than 3 months) Please state the purpose of use "wholesale permit".

  Activities:
  

  • Information on the type of medicinal products traded, information on medicinal products with
    special requirements
  • Information on whether medicinal products are packaged, repackaged or labeled
  • Information on whether medical samples are stored and shipped.
  • List of suppliers
  • List of companies to be supplied

  Information on the quality assurance system operated in accordance with § 1a AM-HandelsV:
  

  • List of contents of the quality assurance system
  • Procedural instructions

  Declarations:
  

  • Informal declaration by the applicant,
    
    • in which they undertake to observe and comply with the regulations applicable to the proper operation of the wholesale business
    • that there are currently no criminal proceedings against them
  • Informal declaration by the responsible person,
    
    • that they will inform the competent supervisory authority immediately if there are any changes to their function as a responsible person (changed area of responsibility, departure from the wholesale company)
    • that there are currently no criminal proceedings against them
    • that they can devote the necessary time and manpower and that they have the necessary personnel and material resources at their disposal to fulfill their obligations under medicinal product law

  Further documents will be requested if required

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.

Please note that there is a fee for issuance of the permit pursuant to Section 501.13 of the current Bremen Health Care Cost Ordinance.

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

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

• § 52a Arzneimittelgesetz (AMG)

• Merkblatt Antrag auf Erteilung der Großhandelserlaubnis