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Source: BUS Sachsen-Anhalt (Linie6Plus)

Applying for an operating license for a hospital pharmacy

Description

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.

  • 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
  • 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

You may only start operating your hospital pharmacy once the competent authority has granted you permission to do so.

Action before the administrative court

State Administration Office

Federal Ministry of Health (BMG)

The text was automatically translated based on the German content.

Authority
Landesverwaltungsamt Sachsen-Anhalt - Gesundheitswesen, Pharmazie
Post Office Box 200256
06003 Halle (Saale), Stadt
Ernst-Kamieth-Straße 2
06112 Halle (Saale), Stadt
0345 514-1286

Remark: Use this hotline for questions about compensation under the Infection Protection Act.
0345 514-1746

Remark: Use this address for questions about compensation under the Infection Protection Act.

Mon. - Thurs.: 9:00 - 15:00
Fri.: 9:00 a.m. - 12:00 p.m.

Please note:
Appointments can also be made outside office hours by individual arrangement. Please note that individual departments have different opening hours. These can be found on the respective department's website.

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