Konzession für private Kranken- und Entbindungsanstalten sowie Nervenkliniken beantragen

• § 30 Gewerbeordnung (GewO) – Privatkrankenanstalten
• Sächsisches Kostenverzeichnis (SächsKVZ) - Nr. 46 Gewerberecht

Licence for entrepreneurs of private hospitals and private maternity clinics as well as private mental hospitals in accordance with Section 30 of the Industrial Code (GewO)

If you want to run a private hospital, you need a licence under trade law.

A hospital within the meaning of commercial law is a facility that is used for the treatment and care of patients and in which they are treated as inpatients under constant medical supervision, i.e. where they are also accommodated and catered for.

Note: Only operators of a private, commercially operated hospital (i.e. with the intention of making a profit) require a licence under commercial law. No licence is required:

• public-law facilities
• Facilities that are operated for charitable, benevolent or scientific purposes and only cover their costs

Operators of a private hospital

If you want to run a hospital, you do not have to be a doctor yourself. A private hospital can be operated by natural persons, partnerships (such as GbR, OHG, KG) and legal entities (e.g. GmbH). In the case of partnerships, each partner involved in the administration and management of the facility requires a separate licence.

Doctors working on a freelance basis do not require a licence under) if the establishment is used for the exercise of their freelance activity, such as the outpatient practice of a surgeon. However, a licence is required if and insofar as the self-employed doctor sets up or maintains a private hospital as an independent means of generating a permanent source of income.

Note: The licence is of a personal and material nature and is therefore linked to a specific person and specific premises. It is also granted for the specific type of business applied for (private hospital or private maternity centre, private mental hospital). It expires when the business is closed, the owner dies or the legal entity ceases to exist. It cannot be transferred to another person. The competent authority must be notified of any changes (such as a change of managing director, etc.), and the licence may need to be amended or a new licence may be required if the business owner changes, a move to new premises or a change in the type of business is intended.

The licence must state whether the institution is used to operate a private hospital, a private maternity hospital or a private mental hospital (or a combination of these facilities). Homes in which mentally ill or mentally handicapped people are accommodated and only occasional medical care is provided are not private hospitals.

Please note! The licence does not replace the other permits and approvals required for the lawful operation of the facility (e.g. building permit/approval of change of use in the case of changes to the building or rooms).

Single point of contact

The business is not covered by the EU Services Directive. The relevant administrative procedures can therefore not be handled via the Point of Single Contact.

As a rule, you must enclose the following documents with your application and the brief description of your business.

Further documents may be required in individual cases:

I. Information on the entrepreneur

for natural persons:

1. Personal details (name, place and date of birth, residential address)
2. Certificate of good conduct for submission to an authority in accordance with Section 30 (5) BZRG (document type OG)
3. Information from the central trade register in accordance with Section 150 (5) GewO for submission to an authority (document type 9)
4. Certificate in tax matters (original, not older than 3 months)
5. Information from the debtor register of the competent local court (application via the joint enforcement portal of the federal states (www.vollstreckungsportal.de, not older than 3 months)
6. Information from the insolvency register of the competent local court (original, not older than 3 months)

for legal entities:

Proof of the legal entity:

1. current extract from the commercial register (copy)
2. Articles of association (copy)
3. Information from the central trade register in accordance with § 150 Para. 5 GewO for submission to an authority (document type 9)
4. Certificate in tax matters (original, not older than 3 months)
5. Information from the debtor register of the competent local court (application via the joint enforcement portal of the federal states (www.vollstreckungsportal.de, not older than 3 months)
6. Information from the insolvency register of the competent local court (original, not older than 3 months)

Proof of the legal entity's representative(s) (managing director(s)/board member(s)):

1. Certificate of good conduct for submission to an authority in accordance with Section 30 (5) BZRG (document type OG)
2. Information from the central trade register in accordance with Section 150 (5) GewO for submission to an authority (document type 9)
3. Certificate in tax matters (original, not older than 3 months)
4. Information from the debtor register of the competent local court (application via the joint enforcement portal of the federal states (www.vollstreckungsportal.de, not older than 3 months)
5. Information from the insolvency register of the competent local court (original, not older than 3 months)
6. current extract from the commercial register as proof of authorisation to represent a legal entity (copy)

II. details of the medical director and deputy medical director

1. Appointment (name, date of birth, home address)
2. Appointment agreement (copy)
3. Medical employment contract without salary details (copy)
4. Licence to practice medicine (officially certified copy)
5. Specialist medical certificates (officially certified copy)
6. Clearance certificate from the Saxon State Medical Association (original)
7. Certificate of good conduct for submission to an authority in accordance with § 30 para. 5 BZRG (document type OB)

III. information on personnel

1. itemised staffing plan (physicians with details of specialist, nursing staff, medical-technical staff) in full-time equivalents (FTE) andheads ,
2. Service instructions
3. Regulations for medical on-call duty in the evening, at night, on Sundays and public holidays; in the case of on-call duty: indication of the time in minutes until the doctor is present in the private hospital

IV. Information on hospital operations

1. Number of beds (per department and total number of beds)
2. Occupancy overview for all patient rooms (number of beds per room and allocation to speciality, if not evident from building drawings)
3. List of the range of services and treatments
4. current hygiene and disinfection plan for the facility (copy)
5. current hygiene protocol from the responsible health authority (copy; if already available; if not yet available, building hygiene approval from the responsible health authority)
6. House rules (copy)
7. Provisions on conflict management/supervision or designation of contact persons and procedures for patient complaints
8. Service contract for the cleaning of the clinic rooms by a certified cleaning company (copy)
9. Service contract for the cleaning/preparation of laundry for patient beds and clinic staff by a certified laundry cleaning company (copy)
10. Proof or contract for patient catering (copy)
11. Details (what/where) of care measures in the event of complications (emergency kit, ventilator, defibrillator, emergency laboratory and emergency power supply)
12. List of medical-technical equipment
13. Proof of connection to medical-technical services, laboratory services, pharmacy (copy)
14. Co-operation agreements with other clinics or doctors (copy)

V. Details of the building

1. Rental or lease agreement without price details (copy)
2. Construction drawings (copy)
3. Building description, if not evident from building drawings (copy)
4. Building permit / building use change permit (copy)
5. Declaration as to whether the building is also occupied or used by other persons (this also includes outpatient practices - please show their location in the building)
6. Escape and rescue route plan

VI. after the licence has been granted

Business registration (GewA 1) with the responsible trade authority (copy)

A prerequisite for the granting of the licence is that there are no grounds for refusal.

The licence will be refused in the following cases:

• If there are facts that indicate the unreliability of the entrepreneur with regard to the management or administration of the clinic. In addition to a lack of financial capacity, tax debts or relevant previous convictions, the fact that you have already had a licence withdrawn or have operated a private hospital without the necessary licence is also considered an indication of unreliability.
• If there are facts that make it appear that adequate medical and nursing care for patients cannot be guaranteed. Although you do not have to be a doctor yourself, you must ensure that sufficient medical and nursing staff are available (e.g. by employing doctors and nursing staff) and that a certain minimum standard is guaranteed for the medical and technical equipment.
• If, according to the descriptions and plans submitted, the structural and other technical facilities of the centre or clinic do not meet the requirements of the health authorities. The licence is granted for certain rooms, but does not replace the building permit.
• If the institution or clinic is to be housed in only part of a building that is also occupied by other persons and its operation may cause considerable disadvantages or dangers for the other occupants of this building.
• If the institution or clinic is intended to accommodate persons with infectious diseases or the mentally ill and its location may cause considerable disadvantages or dangers for the owners or residents of neighbouring properties.

EUR 1,200.00 to EUR 7,500.00

• Apply for the licence in writing to the competent authority. Your application must include a description of the establishment and the following required documents.
• The competent authority, in consultation with the local police and the municipal authorities, will check whether you or your hospital fulfils the requirements and will issue the permit if necessary.
• The licence may be subject to ancillary provisions such as requirements and conditions.

Application: in good time before the planned commissioning

Objection (details in the notification)