Procedure descriptions

Apply for an operating licence for a hospital pharmacy

If you want to operate a hospital pharmacy as the owner of a hospital, you must apply for a licence 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 licence, 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.

Responsible authority

the regional council responsible for the location of the hospital pharmacy

Regierungspräsidium Freiburg

Hausanschrift

Bissierstraße 7
79114 Freiburg i. Br.
To the electronic timetable information

Contact

Telefon (07 61) 2 08-0
Fax (07 61) 2 08-39 42 00
E-Mail poststelle@rpf.bwl.de
Servicekonto Sichere Servicekonto-Nachricht über service-bw.de senden

Details

Prerequisite

  • You must employ a pharmacist who fulfils the requirements of the Pharmacy Act
  • Proof of the rooms required for hospital pharmacies in accordance with the Pharmacy Operating Regulations

Procedure

You can apply informally to the competent authority for a pharmacy operating licence. Your application must contain the following information:

  • Address of the organisation responsible for the hospital
  • Telephone number where you can be reached during the day
  • Name of the pharmacy (if available), street, postcode and town/city
  • Date of the planned opening or takeover

The required documents listed below must be attached to the application.

Alternatively, you can apply for the licence using the online application.

Deadlines

You may only start operating your hospital pharmacy once you have been authorised to do so by the competent authority.

Required documents

  • 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 specialised 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 following the licence to practise as a pharmacist
  • Licence certificate (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 authorisation to practise 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 (e.g. employment contract)
    • the completeness and accuracy of the information

Costs

Billing is based on the current version of the fee regulations of the Ministry of Social Affairs.

Miscellaneous

The staff required for the proper operation of the hospital pharmacy, in particular the pharmaceutical staff, must be available in sufficient numbers. The personnel requirement is determined by the type and scope of a medically appropriate and sufficient supply of the hospital with medicinal products and pharmacy-only medical devices, taking into account the size, type and service structure of the hospital.

In the case of a new establishment or relocation, an acceptance inspection is carried out by the competent authority as part of the procedure.

Legal basis

Gesetz über das Apothekenwesen (Apothekengesetz -ApoG):

  • § 14

Verordnung über den Betrieb von Apotheken (Apothekenbetriebsordnung - ApBetrO):

  • Dritter Abschnitt: Der Betrieb von Krankenhausapotheken

Release note

Machine generated, based on the German release by: Sozialministerium Baden-Württemberg, 11.08.2025