Prerequisites
They meet certain personnel and material requirements.
They indicate a responsible person.
Documents required
- If you have your headquarters in Hamburg:
- Business registration if you are not yet listed in the commercial register
- If your headquarters are outside Hamburg:
- Certified copy of the commercial register extract (if applicable also of the general partner), which is not older than 3 months
- Business registration if the business premises in Hamburg are not registered in the commercial register
- Floor plan of the rooms in which medicines are stored and distributed, in duplicate on a scale of 1: 100 with the designation of the operating rooms and indication of the square meters and essential furnishings as well as the storage areas (quarantine storage, restricted storage)
- Declaration in which you or the managing director or the board of directors undertake to observe and comply with the regulations applicable to the proper operation of the wholesale business.
- Police clearance certificate of the applicant or managing person or the board of directors of document type 0 for submission to an authority according to Section 30 Paragraph 5 BZRGU, which is not older than 3 months and a declaration that there are currently no criminal proceedings (please state company name, file number and purpose when applying).
- Proof of the qualifications of the responsible person (professional career, certificates) in certified copy
- Police clearance certificate of the responsible person (certificate type 0 for submission to an authority according to Section 30 Paragraph 5 BZRG, not older than 3 months) and a declaration from the responsible person that there are currently no criminal proceedings against him or her.
- (Please state company name, reference number and purpose when applying.)
- Personal declaration by the responsible person that he or she will immediately inform the competent authority if there are any changes to his or her function as responsible person (change in area of responsibility, leaving the wholesale business).
- organization chart
- List of suppliers
- List of customers and drug purchasers, with the exception of domestic pharmacies)
Table of contents of your quality assurance system (for example, list of procedural instructions)
Please note
You do not need a permit for wholesale activities that are carried out as part of normal pharmacy operations. This applies, among other things, to:
- the supply of medicinal products to doctors (outpatient supplies) or hospitals (clinical supplies according to Section 14 ApoG) within Germany,
- Returns to pharmaceutical wholesalers, returns to wholesalers as part of regular stock clearance at the pharmacy,
- the purchase of medicinal products within the framework of purchasing groups or passing them on to other pharmacies, provided that no profit is to be made in doing so and
- the distribution of medicines within a branch network.
The Medicines Act also applies to medical gases, active substances produced using biotechnology and genetic engineering, blood and blood products, radioactive medicines, tissues and tissue preparations such as bones, vessels and corneas.
You must enclose the wholesale trade permit with your registration with the commercial register. If your company is not yet registered in the commercial register, you can obtain a clearance certificate from the relevant authority. On this basis, which is binding on the registry court, your company can be registered in the commercial register.
Deadlines
You need a permit before you can start wholesale distribution of medicinal products. The competent authority must generally make a decision on the application for a permit within three months.
