Healthcare & Pharmacy

Operating a private hospital, private maternity clinic, or private psychiatric facility in Germany requires a concession (Konzession) under Section 30 of the Trade Regulation Act (GewO). This applies to commercially operated facilities providing inpatient treatment. Non-profit facilities with a tax exemption are not subject to this requirement, nor are outpatient-only practices or day clinics.You apply at the competent state authority (typically the district government or health authority). The authority examines whether sufficient qualified medical and nursing staff is available, whether the premises meet structural and technical health standards, and whether the operator is commercially reliable. The concession can be denied if any of these requirements are not met. The facility is subject to ongoing supervision by the health authorities.

Issued by: Trade Office / Public Health Authority

Operating a residential care home (Pflegeeinrichtung) for elderly or disabled persons in Germany requires a license under the relevant state home law (Landesheimgesetz or equivalent). Each federal state has its own law regulating care facilities, replacing the former federal Home Act (Heimgesetz). Additionally, to bill through the statutory care insurance, you need a care provision contract (Versorgungsvertrag) with the Pflegekassen under SGB XI.The state supervisory authority (Heimaufsicht), typically part of the local or regional government, examines your staffing plan, building and room standards, care concept, and quality management system. Facilities are subject to regular inspections, usually at least once a year. You must also comply with the Residential and Care Contract Act (WBVG) for contracts with residents.

Issued by: Care Home Supervisory Authority

Operating a private ambulance service or patient transport company requires a license under the emergency services legislation (Rettungsdienstgesetz) of your Bundesland. Since rescue services are a state-level responsibility, requirements vary across Germany.You apply at the competent transport or health authority. The authority checks your personal reliability, financial capacity, and professional competence, which can be demonstrated through a qualification exam or at least three years of management experience in emergency services. Your vehicles and equipment must meet medical standards, and you must employ qualified paramedic staff. The authority may deny the license if granting it would impair the functioning of the existing public emergency service system in your operating area.

Issued by: Emergency Services Authority / District Administration

Manufacturers of medical devices must obtain CE marking through a conformity assessment before placing products on the EU market. Under the EU Medical Device Regulation (MDR 2017/745), devices are classified into risk classes I, IIa, IIb, and III. Class I devices can be self-certified, while higher-risk classes require involvement of a notified body.You must register your company and products in the German Medical Device Information and Database System (DMIDS) at the Federal Institute for Drugs and Medical Devices (BfArM). From May 2026, registration moves to the EU-wide EUDAMED database. A technical documentation file, a quality management system, and clinical evaluation are required. The process and timeline depend heavily on the device risk class.

Issued by: Federal Institute for Drugs and Medical Devices (BfArM)

Medical supply stores, orthopedic technicians, hearing aid acousticians, and opticians that want to supply medical aids (Hilfsmittel) at the expense of statutory health insurance must obtain prequalification under Section 126 SGB V. Without prequalification, you cannot bill health insurance funds for medical aids you dispense.Prequalification is carried out by accredited prequalification bodies that verify your professional expertise, staffing, premises, and organizational setup against criteria set by the GKV-Spitzenverband. After successful prequalification, you receive authorization valid for all statutory health insurance funds for five years. You then negotiate supply contracts with individual insurance funds or their associations to determine pricing and product scope.

Issued by: Accredited Prequalification Body

To operate a home care service (ambulanter Pflegedienst) and bill through the statutory long-term care insurance system, you need a care provision contract (Versorgungsvertrag) under Section 72 SGB XI. Without this contract, your service cannot be reimbursed by the Pflegekassen. You also need to meet state-level notification or licensing requirements, which vary by Bundesland.The contract is concluded with the state associations of long-term care insurance funds (Landesverbände der Pflegekassen). Key requirements include employing a qualified nursing professional as care manager, demonstrating efficient and cost-effective care delivery, and paying staff according to a collective agreement or equivalent. The contract defines your service area and the types of care you may provide.

Issued by: Long-term Care Insurance Funds / Medical Service

Opening a pharmacy in Germany requires a pharmacy operating license (Apothekenbetriebserlaubnis) under the Pharmacy Act (ApoG). Only licensed pharmacists (Apotheker) with a valid German Approbation may apply. Each pharmacy location needs its own license, and one pharmacist may operate up to three branch pharmacies in addition to a main pharmacy.You apply at the state health authority responsible for your location. Required documents include your Approbation certificate, a police clearance (Führungszeugnis), proof of recent pharmaceutical work experience, and floor plans of the pharmacy premises showing that they meet size and equipment standards. The authority inspects the premises before issuing the license. Processing typically takes several weeks.

Issued by: State Health Authority

Selling over-the-counter (OTC) medicines outside of pharmacies in Germany, for example in drugstores, supermarkets, health food shops, or pet supply stores, requires a proof of expertise (Sachkundenachweis) under Section 50 of the Medicines Act (AMG). At least one person with the required qualification must be present in the business at all times when OTC medicines are being sold.The expertise is demonstrated by passing the IHK examination for retail trade in over-the-counter medicines. The written exam consists of 50 single-choice questions covering pharmaceutical knowledge, plant-based medicines, and legal regulations. Pharmacists, pharmaceutical technical assistants, and certain other healthcare professionals are automatically exempt from the exam. You must display the certificate visibly in the store.

Issued by: Chamber of Commerce (IHK) / Medicines Supervisory Authority

Operating a pharmaceutical wholesale business in Germany requires a license under Section 52a of the Medicines Act (AMG). This covers any business that procures, stores, and distributes medicines to pharmacies, hospitals, or other authorised recipients. Over-the-counter medicines not restricted to pharmacies are exempt.You apply at the state health authority where your business premises are located. The authority must decide within three months. Requirements include suitable premises with proper storage conditions (temperature control, security, separation of product categories), a qualified responsible person (verantwortliche Person) with pharmaceutical expertise, and a written commitment to comply with Good Distribution Practice (GDP). The authority inspects the premises before issuing the license and conducts periodic follow-up inspections.

Issued by: State Health Authority

Mail-order sale of pharmacy-only medicines requires a permit under Section 43(1) of the Medicinal Products Act. The prerequisite is the operation of a public pharmacy in Germany. The mail-order pharmacy must be registered with BfArM (Federal Institute for Drugs and Medical Devices), which maintains the official register of authorized online pharmacies and issues the EU common logo.You need to demonstrate a secure ordering and shipping process, qualified pharmaceutical advice by phone or email, and compliance with data protection requirements. The permit is issued by the competent state pharmacy supervisory authority.

Issued by: Zuständige Landesbehörde

Any business that commercially manufactures medicinal products in Germany needs a manufacturing license (Herstellungserlaubnis) under Section 13 of the Medicinal Products Act (AMG). This applies to pharmaceutical companies, contract manufacturers, and businesses involved in packaging or labeling of medicines.You apply to the state authority responsible for pharmaceutical oversight in your Bundesland. The authority inspects your premises, equipment, and processes for compliance with Good Manufacturing Practice (GMP). You must appoint a qualified person (Sachkundige Person) responsible for batch release. Applications should be submitted at least five months before the planned start of manufacturing. The license specifies which product types and manufacturing steps are covered.

Issued by: State Health Authority