• 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 (HR) 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, which the registration court is bound to, the entry in the commercial register can be made.

• Submission of floor plans of the premises in which wholesale activities take place.

• 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. In addition, essential fixtures and fittings as well as the individual storage areas (e.g. quarantine storage, restricted storage, cold 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 Ofor 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 and purpose when applying).

• Proof of the responsible person's qualifications (signed CV, references and certificates of professional qualifications)

• Certificate of good conduct of the person responsible (document type O 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 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.