The German market-access glossary

Germany's law for pricing new medicines: an early benefit assessment by the G-BA, then a negotiated reimbursement price. The added-benefit rating, not your home price, sets the ceiling.

The incremental clinical benefit of a new medicine over an appropriate comparator, rated by the G-BA on IQWiG's assessment. It is the single biggest driver of the negotiated price.

The standard-of-care treatment against which added benefit is judged. Choosing and defending the comparator is often the decisive AMNOG battle.

The negotiated price agreed with the GKV-Spitzenverband after AMNOG, applying from the seventh month; arbitration decides if the parties disagree.

A fixed reimbursement amount set for a group of comparable products; the insurer pays up to that cap and the patient covers any excess.

The annex to the Arzneimittel-Richtlinie that holds the G-BA's benefit-assessment resolutions for individual medicines — where a drug's added-benefit rating is published.

The case-fee system that funds inpatient hospital care. Most devices used in hospitals are paid for inside the DRG lump sum, not separately.

A route for genuinely new inpatient methods not yet covered by a DRG to receive temporary extra hospital funding while evidence and permanent reimbursement are built.

The fee schedule for outpatient (office-based) care. Devices and procedures used by resident physicians are reimbursed through EBM positions.

The aids-and-appliances directory. Certain devices reach patients — and reimbursement — by being listed as a Hilfsmittel rather than through DRG or EBM.

The 2026 cost-containment law (in force 30 July 2026): tighter AMNOG evidence, a compressed free-pricing window, restructured DiGA reimbursement and new manufacturer discounts.

A confidential discount agreement between a manufacturer and a sickness fund; it often decides which product a pharmacy actually dispenses.

The substitution rule that lets (or requires) a pharmacy dispense a therapeutically equivalent, often cheaper, product unless the prescriber excludes it.

The licence to place a medicine on the market — via the EU centralised procedure (EMA), or decentralised, mutual-recognition or national routes.

The EEA-established entity that legally holds a medicine's authorisation and carries the associated obligations. A non-EU company cannot be the MAH itself.

The EU-resident Qualified Person for Pharmacovigilance, personally responsible for a company's drug-safety system.

The German-law safety officer responsible for pharmacovigilance and risk defence for a marketed medicine.

The person who certifies and releases each batch of a medicine before it reaches the market — a legal prerequisite for supply.

Good Manufacturing Practice and Good Distribution Practice — the quality standards for making and moving medicines, enforced by inspection.

The continuous monitoring, assessment and reporting of a medicine's safety for as long as it is on the market.

The German Medicines Act — the legal basis for authorisation, manufacturing and import licences and pharmacovigilance duties.

Germany's implementation of EU medicine serialisation — the anti-falsification system verifying packs from wholesaler to pharmacy.

The EU framework for clinical trials, run through CTIS with a coordinated assessment across member states, plus national ethics-committee involvement.

The EU regulation governing medical devices — classification, technical documentation, clinical evidence and CE marking.

The separate EU regulation for in-vitro diagnostics, which reclassified most tests into higher, Notified-Body-reviewed classes.

The conformity marking that lets a device be placed on the EU market. It is permission to sell — not a price or a guarantee of reimbursement.

An accredited organisation that carries out the conformity assessment for devices above the lowest risk class under MDR/IVDR.

The Person Responsible for Regulatory Compliance a manufacturer (and a non-EU maker's Authorised Representative) must appoint under MDR/IVDR.

The EU-based party a non-EU manufacturer must appoint to place a device on the Union market and act before the authorities.

The EU database for medical devices — economic-operator, device (UDI), certificate and vigilance registration.

The internationally recognised quality-management-system standard for medical-device manufacturers.

The G-BA assessment of new examination and treatment methods that rely on a high-risk device — a hospital-access gate for innovative medtech.

A low-risk medical-device app that doctors can prescribe and statutory insurers reimburse once it is listed in the BfArM directory.

The BfArM process that decides on directory inclusion within 90 days of a complete application — via permanent or provisional listing.

The evidence standard for a DiGA: either a medical benefit or a patient-relevant improvement in the structure or process of care.

The German data-security standard a DiGA must meet, evidenced per app — a hard gate for listing, on top of GDPR and ISO 27001.

Application-accompanying success measurement. Since 2026, at least 20% of a DiGA's reimbursement is tied to outcomes captured this way.

The sibling of DiGA for the long-term care setting — digital applications used in nursing and care rather than treatment.

The Federal Institute for Drugs and Medical Devices — authorises most medicines, runs the DiGA fast-track and holds medical-device tasks.

The federal institute responsible for biological medicines — vaccines, blood and tissue products, and advanced therapies.

The top self-governance body that defines the statutory benefit catalogue and runs the AMNOG benefit assessment.

The Institute for Quality and Efficiency in Health Care — the G-BA's scientific assessor of a medicine's added benefit.

The National Association of Statutory Health Insurance Funds — the payer body that negotiates medicine and DiGA prices.

The EU agency behind the centralised authorisation procedure that yields one marketing authorisation valid across the Union.

The EU-level clinical assessment (from 2025 for oncology and ATMPs, expanding to high-risk devices) that increasingly feeds national pricing decisions.