Applying for a licence for a private clinic

Course description

Operators of private hospitals (private clinics) that are run commercially, i.e. with the intention of making a profit, generally require a licence in accordance with Section 30 of the German Industrial Code (GewO).

A hospital is eligible for a licence if the facility in question meets the minimum requirements in terms of personnel, equipment, space and organisation based on its concept and medical orientation and none of the grounds for refusal listed in the law apply.

Required documents

Letter of application

Clinic Concept

Appointment of the operators

• Business registration
• Brief CV
• Certificate of Good Conduct (document type ‘O’)
• Self-declaration regarding previous convictions – pending criminal proceedings
• Administrative fine proceedings for offences relating to a commercial activity
• Pending proceedings to prohibit business operations
• Information from the local magistrates’ court regarding entries in the insolvency register
• Information from the Central Trade Register for submission to the authorities (to be applied for at the local council of residence) for the legal entity and for all legal representatives

for limited liability companies (GmbH) / other legal entities

• Articles of Association, memorandum and articles of association, list of shareholders
• Most recent extract from the Commercial Register or Co-operative Register
• Business registration
• Certificate from the local civil court regarding entries in the insolvency register for the legal entity and for all legal representatives
• Information from the local civil court regarding entries in the debtors’ register
• Tax clearance certificate

In addition, from the managing directors/legal representatives:

• Self-declaration regarding previous convictions – pending criminal proceedings
• Administrative fine proceedings for offences relating to a commercial activity
• Pending proceedings to prohibit business operations
• Information from the local civil court regarding entries in the insolvency register
• Information from the Central Trade Register for submission to the authorities (to be applied for at the local authority of residence) for the legal entity and for all legal representatives

Appointment of the medical director and heads of specialist departments, including their deputies. Medical director or their deputy: in each case, submission

• of the medical licence
• where applicable, the doctoral degree
• evidence of specialist qualification, including the area of specialisation and other evidence of further training
• Certificate of good conduct (document type ‘O’)
• Confirmation from the Medical Association that no disciplinary proceedings have been initiated and no disciplinary convictions have been handed down.

Head of Department and Deputy Head:

• Confirmation from the Medical Association that no disciplinary proceedings have been initiated and no disciplinary convictions have been handed down.

Spatial/architectural plan of the clinic premises

• Cadastral site plan of the building showing compass directions
• Building, floor and functional plans (2 copies), scale 1:100 (please do not submit electronic files!) with comments from a hospital hygiene specialist, the Trade Inspectorate and the Fire Service

including relevant dimensions, and details of the number, size, fittings and intended use:

• Patient rooms
• Details of the number of beds per room
• Nursing stations/nurses’ stations
• Staff facilities in accordance with the Workplace Regulations (ArbStättV)
• Staff changing rooms
• Toilets (staff/visitors)
• Examination rooms
• Functional departments
• Areas without beds (operating theatre, radiology, laboratory, physical medicine, central sterile supply department, kitchen, laundry, clean/contaminated work areas, storerooms)
• Mortuary
• Occupancy overview (bed plan) broken down by building section or floor.
• Copy of the planning permission (text section only); for an existing clinic, the amended planning permission is required;
• In the case of partial occupancy of a building: a breakdown showing which parts of the building are occupied by persons who may not belong to the institution.

Bed preparation (description of centralised or decentralised bed preparation)

• Technical equipment
• Emergency power supply
• Emergency call system (audible, visual)
• Basic equipment for treating medical emergencies and for resuscitation (first-aid kit, ‘Ulm kit’, defibrillator)
• Medical and technical equipment appropriate to the specialism
• Air conditioning/ventilation
• Lifts (for transporting beds)

Hygiene management: Submission of a hygiene concept developed by a hospital hygiene specialist and tailored to the hospital’s organisation and structures, including a tailored and comprehensive hygiene plan, cleaning and disinfection plans, and evidence of validated medical device reprocessing. Strong recommendation: Involve a hospital hygiene specialist as early as the planning phase to avoid planning or construction defects. The above list is not exhaustive. Depending on the specific design of the concession project, it may be necessary to submit further documentation.

Legal basis

§ 30 Trade Regulations