Betrieb einer Krankenhausapotheke Erlaubnis

To operate a hospital pharmacy you need an operating license.

As a hospital owner, you need a permit to operate a hospital pharmacy.

The hospital pharmacy is responsible for ensuring the proper supply of one or more hospitals with medicines and medical products that require a prescription, as well as for providing information and advice about these products, particularly to doctors, nursing staff and patients.

• Plans for the pharmacy
• Evidence that you met the requirements
• More detailed information on the type and scope is provided by the respective local authority.

You meet all requirements according to Section 14 of the Pharmacy Act:
​​​​You have employed a pharmacist who

• is fully capable of doing business
• has a German pharmacist license
• has the necessary reliability
• there are no criminal or serious moral misconducts against him or her, nor any serious or persistent violations of the Pharmacy Act
• is medically fit to properly manage a pharmacy
• he or she must state whether and at which locations one or more pharmacies will be operated
• They have the prescribed rooms according to Section 21 of the Pharmacy Operating Regulations.

Fees apply. The amount depends on the time required for processing.

• Contact the responsible authority to describe your project and discuss the documents to be submitted.
• Submit your written application together with all required documents to the responsible authority.
• The responsible authority will examine your application and your documents.
• If necessary, the responsible authority will request further documents or information from you.
• The responsible authority will decide on your application.
• If the requirements of the Pharmacy Act are met, you will receive an operating license for the hospital pharmacy.
• The responsible authority will inspect your pharmacy operations and carry out an inspection.
• After acceptance, you may begin operating the hospital pharmacy.

Processing usually takes 4 to 8 weeks.

Submit the application at least 2 months before the planned opening of the pharmacy so that all documents are complete at least 2 weeks before the opening date.

• If it becomes known that not all requirements have been met, the permit will be withdrawn.
• The permit will be revoked if any of the requirements are no longer met.
• The license will be revoked if you or the person responsible for managing the pharmacy grossly or persistently violates the Pharmacy Act.

contradiction

• Apply for an operating license for a hospital pharmacy
• Operating a hospital pharmacy permit
• Hospital pharmacies may only be operated with permission.
• A written application must be submitted by the hospital operator.
• The leader must be named in writing.

Justice and Consumer Protection Authority