Procedure descriptions

Apply for a licence to wholesale medicines

If you wish to operate a wholesale business dealing in medicines, you must obtain authorisation from the relevant authority before commencing operations.

The term ‘medicines’ covers not only the relevant preparations available from pharmacies or prescribed by doctors, such as tablets, capsules, ointments, creams, (cough) syrups, drops, vaccines and infusion solutions, but also products that are not immediately recognisable as medicinal products. If in doubt, please contact your relevant regional council.

A wholesale licence can only be granted if you meet certain personal and material requirements. You must also name a responsible person and enclose the documents specified in the Medicines Act with your application.

The licence generally applies to a single business premises only. Where there are several business premises falling within the jurisdiction of different supervisory authorities, a separate application must be submitted for each business premises; this will be processed by the supervisory authority within whose local jurisdiction the respective business premises is situated.

Once you have applied for the relevant authorisation, the wholesale business will be inspected by the competent authority at regular intervals or on specific occasions, for example where a change to the authorisation is required or where there are concerns regarding the safety of medicinal products.

Responsible authority

The regional councils based in Freiburg, Karlsruhe, Stuttgart and Tübingen

Regierungspräsidium Freiburg

Details

Prerequisite

The requirements are set out in the Medicines Act:

In the application, the applicant must

  • specify the particular premises, as well as the activities and medicinal products for which the authorisation is to be granted,

  • submit evidence that they have suitable and adequate premises, plant and equipment to ensure the proper storage and distribution and, where applicable, the proper decanting, packaging and labelling of medicinal products,

  • to appoint a responsible person who possesses the expertise required to carry out the activity, and

attach a written declaration in which he undertakes to comply with the regulations governing the proper operation of a wholesale business.

Procedure

You can submit your application for a wholesale licence under the Medicines Act in writing or electronically.

  • Once you have submitted your application and all the necessary documents are complete, the competent authority will check whether you meet all the requirements.
  • If you meet all the requirements, the competent authority will carry out an inspection of the premises intended for use. During this inspection, the competent authority will ensure that the requirements for granting the licence are met.
  • If the inspection confirms that the requirements have been met, you will be sent the wholesale licence you have applied for.

You may not commence business until you have received the licence.

Deadlines

There are no deadlines for this application that the applicant needs to observe.

Required documents

  • Extract from the Commercial Register showing the company’s registration (not more than 3 months old). 
  • Under the Limited Liability Companies Act (GmbH Act), the application to the Commercial Register must be accompanied by a wholesale licence if the company’s objects require authorisation. In the event that the company has not yet been entered in the Commercial Register, the competent authority may issue a certificate of no objection. On this basis, to which the registry court is bound, entry in the Commercial Register may take place.
  • Submission of floor plans of the premises where medicinal products are stored and distributed.
  • The floor plans should generally be submitted on a scale of 1:100 and should include the names of the premises and their area in square metres. Furthermore, key plant and equipment, as well as the individual storage areas (quarantine storage, restricted-access storage), should be marked on the plans.
  • A declaration by the applicant (managing director or board member) in which they undertake to observe and comply with the regulations applicable to the proper operation of the wholesale business.
  • A police certificate for the applicant (managing director or board member) of ‘Document Type 0’ for submission to a public authority (not older than 3 months), as well as a declaration by the applicant (managing director or board member) stating that no criminal proceedings are currently pending against them (please state the company name, reference number and purpose when applying).
  • Evidence of the responsible person’s qualifications or expertise (professional history and certificates) in the form of certified copies
  • Certificate of good conduct for the responsible person (Document Type 0 for submission to a public authority, not older than 3 months) and a declaration by the responsible person that no criminal proceedings are currently pending against them.
    Please state the company name, reference number and purpose when submitting the application.
  • A personal declaration by the responsible person stating that they will notify the competent authority without delay should any changes arise regarding their role as the responsible person (change in area of responsibility, leaving the wholesale business).
  • Evidence of the appointment of the responsible persons, from which it is clear that they consent to the appointment.
  • List of all business premises and storage facilities for which the licence is to be granted, stating the names and addresses of the business premises, telephone and fax numbers, and email addresses.
  • Organisation chart
  • List of customers and purchasers of medicinal products, excluding pharmacies, within Germany
  • A functioning quality assurance system appropriate to the nature and scope of the activities carried out. Table of contents of the quality management manual, including documents and procedural instructions
  • Evidence of the right to use the wholesale premises under one’s own responsibility. For example, a purchase, lease or tenancy agreement.
  • Details of the scope of the medicinal products wholesale business and the types of medicinal products to be traded
  • Details of the nature of the wholesale activity (trade, decanting, repackaging and/or labelling).

Costs

Fees in accordance with the State Fees Regulation

Processing time

As a general rule, the competent authority must reach a decision on the application for a licence within three months of receiving the complete documentation.

Miscellaneous

none

Detailed information

Areas of responsibility of the regional councils

Legal basis

Arzneimittelgesetz (AMG):

  • § 52a Großhandel mit Arzneimitteln

Verordnung über den Großhandel und die Arzneimittelvermittlung (AM-HandelsV)

Leitlinien der Europäischen Kommission vom 05.11.2013 für die gute Vertriebspraxis von Humanarzneimittteln

Delegierte Verordnung (EU) 2016/161 der Kommission vom 02. Oktober 2015 zur Ergänzung der Richtlinie 2001/83/EG des Europäischen Paralaments und des Ratesdurch die Festlegung genauer Bestimmungen über die Sicherheitsmerkmale auf der Verpackung von Humanarzneimitteln

Release note

Machine generated, based on the German release by: Sozialministerium Baden-Württemberg, 24.08.2026