Applying for an operating license for a hospital pharmacy
If you want to operate a hospital pharmacy as the owner of a hospital, you must apply for a permit to do so.
The hospital pharmacy is a functional unit of a hospital. It is responsible for the safe and proper supply of one or more hospitals with medicines and pharmacy-only medical products.
It also informs and advises doctors, nursing staff and patients about the medicines and medical devices used.
In order to obtain the operating license, you must provide evidence of the prescribed premises and employ a pharmacist who meets the requirements of the Pharmacy Act as a manager.
A hospital does not necessarily need its own hospital pharmacy, but can also be supplied by the pharmacy of another hospital or a public pharmacy (hospital-supplying pharmacy) on a contractual basis.
Who should I contact?
Different regulations in the countries.
Requirements
- You must employ a pharmacist who fulfills the requirements of the Pharmacy Act
- Proof of the rooms required for hospital pharmacies in accordance with the Pharmacy Operating Regulations
Which documents are required?
- Proof of the rooms required for a hospital pharmacy:
- Floor plan of the pharmacy operating rooms
- The size, location, furnishings and function designations of the individual pharmacy operating rooms must be visible
- For new openings: copy of the building permit from the building supervisory authority
- Notification of the number of employees, broken down into specialist staff and other staff
The following documents must be submitted by the head of the hospital pharmacy:
- Identity document, proof of nationality if applicable
- Tabular proof of activity after licensure as a pharmacist
- Certificate of licensure (certified copy or transcript)
- Certificate of good conduct, document type 0 for submission to an authority
- Medical certificate of suitability to properly manage a pharmacy (not older than 3 months)
- Declaration of
- legal capacity
- any criminal proceedings, professional court proceedings and investigation proceedings as well as the authorization to practice the profession with regard to the reliability check
- the operation of other pharmacies
- the complete existence of all contracts and agreements relating to the establishment and operation of the pharmacy
- the completeness and accuracy of the information
What are the fees?
Different regulations in the countries.
Process flow
- First, you should contact your competent authority to describe your project and discuss the scope of the documents to be submitted.
- Next, submit a complete written application.
- Your application will be reviewed by the competent authority.
- If necessary, the competent authority will request further documents.
- If the requirements of the Pharmacy Act are met, you will be issued an operating license.
- Pharmacy operations may only commence after an acceptance inspection by the competent authority.
What deadlines do I have to pay attention to?
You may only start operating your hospital pharmacy once the competent authority has granted you permission to do so.
Processing duration
Different regulations in the countries.
Appeal
Action before the administrative court
