Apply for an operating license for a hospital pharmacy

Prerequisites

If the competent authority determines that the requirements according to § 14 Pharmacy Act are met, the operating license is to be granted according to the application.

Documents required

Documents in accordance with Section 14 Paragraph 1 of the Pharmacy Act must be submitted.
The respective locally responsible authority provides more precise information on the type and scope.

Please note

No.

Deadlines

The application should be submitted at least 2 months before the planned opening of the pharmacy and be complete 2 weeks before the opening date.

Procedure

• First of all, you should contact your competent authority to describe your project and to discuss the scope of the documents to be submitted.
• Next, submit a complete written application.
• Your application will be examined by the competent authority.
• If necessary, the competent authority will request additional documents.
• If the requirements of the Pharmacy Act are met, you will be granted an operating license.
• Pharmacy operations may only be started after an acceptance inspection by the competent authority.

Processing time

4 – 8 weeks

Fees

• Variable depending on time


• State law fees

Legal remedies

contradiction

Legal basis

• § 14 Pharmacy Act (ApoG)


• § 2 Pharmacy Act (ApoG)


• Third section of the pharmacy operating regulations

Anyone who wants to operate a hospital pharmacy as the operator of a hospital must apply for a permit in accordance with Section 14 of the Pharmacy Act (ApoG). The operating license for a hospital pharmacy must be applied for in writing from the responsible supervisory authority.

The hospital pharmacy is responsible for ensuring that one or more hospitals are properly supplied with medicines and pharmacy-only medical products, as well as providing information and advice about these products, in particular for doctors, nursing staff and patients.