Apply for a license for the wholesale of medicinal products

You can submit the application for a wholesale authorization in accordance with the German Medicinal Products Act in writing or electronically.

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

If you meet all the requirements, you will receive the requested permit.

You may only start your activity once you have received the permit.

The requirements are set out in the Medicinal Products Act:

With the application, the applicant must

• name the specific business premises as well as the activities and medicinal products for which the authorization is to be granted,

• submit evidence that he/she has suitable and sufficient premises, facilities and equipment to ensure proper storage and distribution and, where provided for, proper decanting, packaging and labeling of medicinal products,

• appoint a responsible person who has the necessary expertise to carry out the activity, and

to enclose a declaration in which he undertakes in writing to comply with the regulations applicable to the proper operation of a wholesale business.

• As a rule: Extract from the entry of the company in the commercial register (not older than 3 months).

• According to the GmbH Act, the wholesale license must be enclosed with the application to the commercial register if the object of the company requires approval. In the event that the company has not yet been entered in the commercial register, the competent authority can issue a certificate of non-objection. On this basis, to which the registration court is bound, the entry in the commercial register can be made.

• Submission of floor plans of the rooms in which medicinal products are stored and distributed.

• As a rule, the floor plans should be submitted on a scale of 1:100 and include the name of the business premises and the number of square meters. Furthermore, essential furnishings and the individual storage areas (quarantine storage, restricted storage) should be shown.

• Declaration by the applicant (managing director/board member) in which he/she undertakes to observe/comply with the regulations applicable to the proper operation of the wholesale business.

• Police clearance certificate of the applicant (managing director/board member) ofdocument type 0for submission to an authority (not older than 3 months) as well as a declaration by the applicant (managing director/board member) that there are currently no criminal proceedings against him/her (please state company name, file number and purpose when applying).

• Proof of the responsible person's qualifications (professional background, certificates) on the basis of certified copies

• Police clearance certificate of the person responsible (document type 0 for submission to an authority, not older than 3 months) and a declaration by the person responsible that there are currently no criminal proceedings against them.
  (Please state the company name, file number and purpose when applying).

• Personal declaration by the responsible person that they will inform the competent authority immediately if there are any changes to their function as a responsible person (changed area of responsibility, departure from the wholesale company).

• Organizational chart

• List of suppliers

• List of customers/purchasers of medicinal products (except pharmacies in Germany)

• List of contents of your quality assurance system (e.g. list of procedural instructions)

Procedural instructions in accordance with the Ordinance on Wholesale Distribution and Brokerage of Medicinal Products apply.

Is based on the respective administrative fee schedule of the federal state or on the fee statutes of the authorities responsible under federal state law.

The competent authority must generally make a decision on the application for a permit within three months of receiving the complete documentation.

• § 52a Arzneimittelgesetz (AMG)

The text was automatically translated based on the German content.