The AMNOG legal framework does not regulate marketing authorisation. It determines how Germany assesses patient-relevant added benefit after authorisation and how the resulting G-BA resolution feeds into the six-month AMNOG process. The practical submission requirements are covered separately in the AMNOG dossier guide.
AMNOG legal framework at a glance
AMNOG is implemented through several legal and procedural instruments. Each one answers a different question in the German benefit-assessment and reimbursement process.
| Topic | What it governs | Why it matters for the dossier |
|---|---|---|
| Section 35a SGB V | Early benefit assessment | Defines the core dossier obligations |
| AM-NutzenV | Assessment principles | Defines benefit, added benefit and comparator therapy |
| G-BA Rules of Procedure | Operational procedure | Defines procedural and decision-making requirements |
| Section 130b SGB V | Reimbursement agreements | Governs the agreement after the G-BA resolution |
AMNOG legislation at a glance
What does AMNOG stand for?
AMNOG stands for Arzneimittelmarktneuordnungsgesetz, commonly translated as the German Pharmaceutical Market Restructuring Act. It introduced the mandatory early benefit assessment of new medicines from 2011.
What is the central legal basis for the AMNOG benefit assessment?
Section 35a of Book V of the German Social Code is the central statutory basis for the early benefit assessment. It assigns the assessment to the G-BA, requires the pharmaceutical company to submit evidence and defines the principal content of the benefit dossier. (Gesetze im Internet)
Which regulation defines the assessment principles?
The Arzneimittel-Nutzenbewertungsverordnung, abbreviated as AM-NutzenV, defines key concepts and principles for the benefit assessment. These include the meaning of benefit, added benefit, appropriate comparator therapy and the categories used to quantify added benefit. (Gesetze im Internet)
Which law governs reimbursement-price negotiations?
Section 130b SGB V governs reimbursement agreements between the GKV-Spitzenverband and pharmaceutical companies. The negotiation is based on the G-BA resolution adopted after the benefit assessment. (Gesetze im Internet)
What does AMNOG stand for?
AMNOG is the abbreviation for Arzneimittelmarktneuordnungsgesetz. The legislation reorganised the German market-access and reimbursement framework for newly launched medicines.
The law introduced a structured link between three elements:
- the evidence submitted by the pharmaceutical company,
- the G-BA’s decision on added benefit,
- the subsequent negotiation of the reimbursement amount.
The source materials describe the resulting system as a process beginning with the benefit dossier, followed by the scientific assessment, the G-BA resolution and the reimbursement negotiation. They also distinguish the responsibilities of IQWiG, the G-BA and the GKV-Spitzenverband.
AMNOG is often used as a collective term for the entire German early benefit-assessment system. Legally, however, the current framework no longer consists of one isolated act. It is implemented through provisions in the SGB V, the AM-NutzenV, the G-BA Rules of Procedure and related reimbursement rules.
What is the purpose of AMNOG legislation?
The purpose of AMNOG legislation is to assess the added benefit of new reimbursable medicines and use that assessment as a basis for reimbursement-price setting.
The framework separates regulatory market authorisation from national reimbursement assessment.
Marketing authorisation asks whether a medicine has an acceptable balance of efficacy, safety and quality. AMNOG legislation asks whether the medicine offers a patient-relevant advantage compared with the treatment standard relevant to German statutory healthcare.
This distinction has several legal and practical consequences:
- A medicine can be authorised without demonstrating added benefit under AMNOG.
- The German comparator may differ from the comparator used in the regulatory programme.
- The benefit assessment may distinguish between several patient populations.
- The G-BA resolution influences reimbursement but does not replace the later negotiation.
- Evidence suitable for regulatory approval may require additional analyses for the German assessment.
The AM-NutzenV defines added benefit as a benefit that is quantitatively or qualitatively greater than the benefit of the appropriate comparator therapy. It defines benefit through patient-relevant therapeutic effects, including improvements in health status, duration of disease, survival, adverse events and quality of life. (Gesetze im Internet)
Which laws and regulations govern the AMNOG system?
The AMNOG system is governed primarily by the SGB V, the AM-NutzenV and the G-BA Rules of Procedure. These legal layers have different functions.
| Legal instrument | Main function |
|---|---|
| Section 35a SGB V | Establishes the early benefit assessment |
| Section 130b SGB V | Regulates reimbursement agreements and arbitration |
| AM-NutzenV | Defines assessment principles and key concepts |
| G-BA Rules of Procedure, Chapter 5 | Specifies dossier forms and procedural details |
| G-BA Pharmaceutical Directive, Annex XII | Contains product-specific benefit resolutions |
Section 35a SGB V establishes the benefit assessment
Section 35a SGB V requires the G-BA to assess reimbursable medicines with new active substances.
The statutory assessment includes in particular:
- added benefit compared with the appropriate comparator therapy,
- the magnitude of added benefit,
- the therapeutic significance of added benefit,
- the relevant patient populations,
- treatment costs for statutory health insurance,
- and requirements for quality-assured use.
The pharmaceutical company must electronically submit the required evidence no later than the first placing of the medicine on the market. For a new authorised indication, the statutory text currently provides for submission four weeks after authorisation of that indication. (Gesetze im Internet)
This is an important distinction from older procedural descriptions. Current publication content should use the deadline in the applicable version of Section 35a rather than relying solely on historical training material.
Section 130b SGB V governs the reimbursement agreement
Section 130b SGB V requires the GKV-Spitzenverband and the pharmaceutical company to negotiate a reimbursement amount based on the G-BA benefit resolution.
The reimbursement agreement applies to all statutory health insurers. The private health insurance association is also involved in the statutory framework.
If the parties do not reach an agreement within the statutory negotiation period, an arbitration board determines the contractual terms. The current law states that arbitration follows when no agreement is reached within six months after publication of the relevant G-BA resolution. (Gesetze im Internet)
The AM-NutzenV defines assessment standards
The AM-NutzenV sets out the substantive principles used in the benefit assessment.
Its structure covers:
- scope of the regulation,
- definitions,
- medicines subject to assessment,
- dossier requirements,
- proof and magnitude of added benefit,
- appropriate comparator therapy,
- assessment procedure,
- consultation,
- and disclosure.
The regulation was originally issued in December 2010 and, according to the official consolidated text, was most recently amended in March 2025. (Gesetze im Internet)
The G-BA Rules of Procedure define operational requirements
Chapter 5 of the G-BA Rules of Procedure translates the statutory framework into detailed procedural and dossier requirements.
It governs, among other issues:
- consultation requests,
- formal dossier submission,
- module templates,
- completeness requirements,
- the commenting procedure,
- and the implementation of EU-HTA references in the national dossier.
The G-BA adopted amendments relating to the EU HTA Regulation and the amended AM-NutzenV in July 2025. Those amendments entered into force in November 2025 and include revised dossier templates for Modules 1 to 4. (Gemeinsamer Bundesausschuss)
Which medicines fall within the scope of AMNOG legislation?
AMNOG legislation generally applies to reimbursable medicines with new active substances or new combinations of active substances that are placed on the German market.
The AM-NutzenV specifies that the assessment applies to reimbursable medicines:
- first placed on the market with a new active substance,
- receiving a new authorised indication,
- undergoing reassessment because of new evidence,
- reassessed after expiry of a time-limited resolution,
- or assessed on the initiative of the G-BA under the applicable statutory conditions. (Gesetze im Internet)
The training materials similarly identify reimbursable medicines with new active substances, orphan medicines and certain hospital products as relevant for AMNOG planning. They distinguish these from non-reimbursable medicines, vaccines, medical devices and several special categories.
New active substances
A medicine with a new active substance generally enters the early benefit assessment when it is first placed on the German market.
The company must submit evidence covering the authorised indication, clinical benefit, added benefit, relevant patient groups, costs and requirements for quality-assured use.
New authorised indications
A new authorised indication can trigger a separate benefit assessment. The relevant evidence must be aligned with the wording of the newly approved indication and the patient populations falling within it.
An earlier G-BA resolution for another indication does not automatically answer the assessment question for the new indication.
Medicines without a new active substance
Under specified conditions, the G-BA may also initiate a benefit assessment for a medicine whose active substance is not considered new, particularly where a new authorisation with new data protection has been granted. This authority is set out in Section 35a(6) SGB V. (Gesetze im Internet)
Exemptions for minor budget impact
A pharmaceutical company may apply for exemption where only minor expenditure for the statutory health insurance system is expected.
Section 35a permits the G-BA to exempt the company from the evidence-submission requirement and the medicine from assessment if the expected expenditure is minor. The G-BA may time-limit that exemption and defines further details in its Rules of Procedure. (Gesetze im Internet)
The supplied webinar material refers to an expenditure threshold of less than €1 million within twelve months. Because exemption details can be affected by current G-BA rules, that figure should be checked against the operative procedural text before publication.
What evidence must be submitted under Section 35a SGB V?
Section 35a SGB V requires the pharmaceutical company to submit evidence supporting the benefit assessment at the legally defined submission date.
The statutory dossier must particularly address:
- authorised indications,
- medical benefit,
- added benefit compared with the appropriate comparator therapy,
- the number of patients and patient groups with therapeutically significant added benefit,
- treatment costs for statutory health insurance,
- requirements for quality-assured use,
- and information on participation in the company’s clinical trials at German trial sites. (Gesetze im Internet)
The G-BA operationalises these requirements through the five-module dossier structure.
The legal function of the AMNOG dossier
The AMNOG dossier is the company’s formal evidentiary basis for the national assessment.
The dossier does more than provide clinical study results. It connects:
- the authorised indication,
- the German comparator,
- population estimates,
- clinical outcomes,
- additional analyses,
- costs,
- and implementation requirements.
The supplied materials emphasise that a pivotal clinical trial is not automatically sufficient for the German assessment. The population must correspond to the indication, treatment must follow the product information, the results must be transferable to German care, endpoints must be patient-relevant and the comparison must address the appropriate comparator therapy.
Consequences of an incomplete submission
If the required evidence is not submitted on time or in full despite a G-BA request, added benefit is deemed not proven.
This statutory consequence makes formal completeness a substantive Market Access issue. A missing document or analysis can affect the legal outcome of the assessment, not merely the administrative processing of the dossier. (Gesetze im Internet)
How does AMNOG legislation define benefit and added benefit?
The AM-NutzenV distinguishes the medical benefit of a medicine from its added benefit compared with the appropriate comparator therapy.
Benefit is defined as a patient-relevant therapeutic effect, particularly:
- improvement in health status,
- shortening of disease duration,
- prolongation of survival,
- reduction in adverse effects,
- or improvement in quality of life.
Added benefit is a benefit that is quantitatively or qualitatively greater than the benefit of the comparator. (Gesetze im Internet)
This distinction matters because a medicine may have a demonstrated clinical benefit but still receive the conclusion that no added benefit is proven.
Legal categories for the magnitude of added benefit
The AM-NutzenV provides six outcome categories:
- major added benefit,
- considerable added benefit,
- minor added benefit,
- added benefit that is not quantifiable,
- no added benefit proven,
- and less benefit than the comparator.
The regulation connects these categories to the degree of improvement in patient-relevant outcomes. A major added benefit requires a large and previously unachieved improvement, whereas a considerable or minor added benefit reflects progressively smaller but still relevant improvements. (Gesetze im Internet)
Evidence quality and certainty
The AM-NutzenV also requires assessment of the probability and magnitude of added benefit in light of:
- study quality,
- validity of endpoints,
- and the evidence level.
The regulation lists evidence levels ranging from systematic reviews of randomised trials to expert opinion and descriptive evidence. Randomised trials are therefore given high evidentiary weight, but the legal framework permits the best available evidence where higher-level studies are impossible or inappropriate. (Gesetze im Internet)
How is the appropriate comparator therapy regulated?
The appropriate comparator therapy is the legally relevant treatment standard against which added benefit is assessed.
The AM-NutzenV requires the comparator to be determined according to international standards of evidence-based medicine. It must represent an appropriate therapy in the indication according to the generally accepted state of medical knowledge. The regulation also requires consideration of the actual care situation that would exist without the medicine under assessment. (Gesetze im Internet)
Which therapies can serve as the comparator?
The comparator can include:
- an authorised medicine,
- several equally appropriate treatment alternatives,
- a non-pharmacological intervention,
- best supportive care,
- symptomatic or palliative care,
- or watchful waiting.
The current regulation also permits an off-label medicine to be selected in defined exceptional situations when it represents the established treatment standard under the statutory criteria. (Gesetze im Internet)
Several equally appropriate alternatives
Where several alternatives are equally appropriate, the AM-NutzenV permits added benefit to be demonstrated against any of those therapies.
For evidence planning, this can offer flexibility. It does not eliminate the need to examine whether the pivotal comparator and its implementation correspond to one of the alternatives accepted by the G-BA.
Why comparator law matters before launch
The comparator affects:
- eligibility of clinical studies,
- structure of the target population,
- interpretation of treatment effects,
- the G-BA added-benefit conclusion,
- and the later pricing benchmark.
The legal comparator question should therefore be considered during study planning, not only during dossier writing.
What legal responsibilities do the G-BA, IQWiG and GKV-Spitzenverband have?
AMNOG legislation assigns assessment, decision-making and price negotiation to different institutions.
The G-BA decides on added benefit
Section 35a assigns the assessment responsibility to the G-BA. The committee examines the submitted evidence and decides whether to conduct the assessment itself or commission IQWiG or another party.
The G-BA adopts the legally relevant resolution within three months after publication of the benefit assessment. The procedure must include both written and oral opportunities to comment. (Gesetze im Internet)
The resolution determines in particular:
- the patient population,
- the appropriate comparator therapy,
- the magnitude and certainty of added benefit,
- treatment costs,
- and requirements for quality-assured use.
IQWiG prepares the scientific assessment
IQWiG generally performs the scientific benefit assessment when commissioned by the G-BA.
The supplied materials describe the standard division as assessment by IQWiG and resolution by the G-BA, with a special arrangement for orphan medicines.
IQWiG does not set the reimbursement amount and does not adopt the binding benefit resolution.
The GKV-Spitzenverband negotiates reimbursement
Section 130b assigns the reimbursement negotiation to the GKV-Spitzenverband and the pharmaceutical company.
The negotiation is based on the G-BA resolution. If no agreement is reached within the statutory period, the arbitration board determines the contractual terms. (Gesetze im Internet)
How long does the legally defined assessment process take?
The statutory benefit-assessment process takes six months from the relevant dossier-submission date to the G-BA resolution.
Section 35a provides two consecutive three-month phases:
- The benefit assessment must be completed and published within three months after the relevant submission date.
- The G-BA must adopt its resolution within three months after publication of the assessment. (Gesetze im Internet)
Within the second phase, the G-BA conducts:
- the written commenting procedure,
- the oral hearing,
- and the final deliberation.
The webinar materials visualise this sequence as a three-month assessment followed by a three-week written-comment period, an oral hearing and the final G-BA resolution.
The reimbursement negotiation follows the clinical benefit assessment and has its own legal timeline under Section 130b.
How does AMNOG legislation regulate orphan medicines?
For orphan medicines, the added benefit is initially recognised through the marketing authorisation under the statutory special rule, while the G-BA determines its magnitude.
The AM-NutzenV provides that, for qualifying orphan medicines not required to submit full comparative proof under Section 35a, only the magnitude of added benefit is quantified. The applicable categories are major, considerable, minor or non-quantifiable added benefit. (Gesetze im Internet)
The €30 million turnover threshold
A regular comparative benefit assessment is required after an orphan medicine exceeds the statutory annual turnover threshold of €30 million within statutory health insurance.
Current G-BA procedures continue to identify reassessments triggered by exceeding this threshold. Examples in 2026 include Selumetinib, Momelotinib, Avapritinib and Mirvetuximab soravtansine. (Gemeinsamer Bundesausschuss)
The €30 million threshold is therefore not merely theoretical. It is an active trigger for regular reassessment procedures.
Voluntary regular assessment
Section 35a also allows a pharmaceutical company to make an irrevocable declaration requesting a regular benefit assessment for an orphan medicine under the full evidence requirements. (Gesetze im Internet)
This option can be strategically relevant where a company expects comparative evidence to support a stronger or more robust added-benefit conclusion.
How does AMNOG legislation regulate reimbursement pricing?
AMNOG legislation does not directly assign a final price through the benefit resolution. The G-BA decision provides the basis for a separate reimbursement agreement under Section 130b SGB V.
The reimbursement amount is negotiated
The GKV-Spitzenverband and the pharmaceutical company negotiate a reimbursement amount that applies across statutory health insurance.
Relevant statutory and procedural considerations can include:
- the G-BA added-benefit resolution,
- comparator costs,
- prices of comparable medicines,
- European prices,
- the relevant patient population,
- and other legally defined criteria.
The exact negotiation criteria depend on the current statutory framework and the applicable framework agreement.
Arbitration if no agreement is reached
If no agreement is reached within six months after publication of the G-BA resolution, the arbitration board sets the contractual terms within a further statutory period. (Gesetze im Internet)
The arbitration decision does not suspend the statutory pricing consequences merely because it is challenged in court.
Added benefit and price are connected but not identical
A considerable added benefit does not produce an automatic mathematical price premium. Likewise, a conclusion of no added benefit proven does not by itself specify one exact reimbursement amount.
The G-BA resolution determines the clinical and evidentiary foundation. The reimbursement agreement applies that foundation within the statutory negotiation framework.
What is the difference between AMNOG legislation and the AMNOG process?
AMNOG legislation defines the legal obligations, while the AMNOG process describes how those obligations are implemented in an individual medicine assessment.
| AMNOG legislation | AMNOG process |
|---|---|
| Defines the statutory framework | Describes the procedural sequence |
| Establishes dossier obligations | Begins with a specific dossier submission |
| Assigns institutional responsibilities | Involves IQWiG, G-BA and GKV-Spitzenverband in sequence |
| Defines added-benefit categories | Applies the categories to one medicine |
| Regulates reimbursement agreements | Leads to a product-specific negotiation |
| Applies across medicines | Produces an individual G-BA resolution |
For SEO and user orientation, these topics should remain on separate pages. A reader searching for “AMNOG legislation Germany” is primarily looking for legal bases, institutions and rules. A reader searching for “AMNOG process” is primarily looking for steps, timelines and operational requirements.
How has AMNOG legislation changed since 2011?
AMNOG has developed through repeated amendments to the SGB V, the AM-NutzenV and the G-BA Rules of Procedure.
The core principle has remained stable: new medicines undergo an early benefit assessment and the result informs reimbursement-price negotiations.
Several areas have evolved over time:
- orphan-drug thresholds,
- pricing and reimbursement conditions,
- evidence requirements,
- combination-treatment rules,
- use of routine-practice data,
- clinical trial requirements,
- and integration of EU HTA.
This makes AMNOG a continuing regulatory framework rather than a static law from 2011.
Current clinical-trial provisions
Section 35a now requires information on the number of participants enrolled at German trial sites. For medicines placed on the market from 1 January 2025, the G-BA resolution also determines whether a relevant proportion of clinical-trial activity was conducted within Germany. (Gesetze im Internet)
Combination-treatment provisions
The current statute also contains rules concerning combinations of medicines with new active substances. It permits companies to apply for a determination that a combination can be expected to provide at least considerable added benefit under defined conditions. (Gesetze im Internet)
Medizinforschungsgesetz and reimbursement evaluation
Section 130b requires the Federal Ministry of Health to evaluate the effects of changes introduced by the Medical Research Act on access to innovative and cost-effective medicines. The statutory report is due by the end of 2026. (Gesetze im Internet)
How does EU HTA interact with AMNOG legislation?
The EU HTA Regulation changes the clinical evidence interface but does not replace German added-benefit and reimbursement law.
The AM-NutzenV now explicitly defines the Joint Clinical Assessment and the European dossier. This demonstrates that European clinical assessment has been incorporated into the national legal framework. (Gesetze im Internet)
However, national responsibilities remain.
Germany still determines:
- the final national added-benefit conclusion,
- the relevant German comparator context,
- national population and cost information,
- requirements for quality-assured use,
- and the reimbursement amount.
The G-BA’s amended Chapter 5 rules, effective from November 2025, regulate how the European dossier and EU-HTA results interact with national dossier submission. (Gemeinsamer Bundesausschuss)
The JCA does not replace Section 35a SGB V
A Joint Clinical Assessment provides a European clinical assessment. The G-BA still has a statutory obligation to adopt a national resolution under Section 35a.
For manufacturers, this means that European evidence must be mapped against the German legal assessment requirements.
The AMNOG dossier remains relevant
The supplied Delta Dossier material notes that the existing national module structure remains in place. References to the European dossier are possible, but the company must determine whether the European material is sufficient or whether updated and supplementary evidence is required.
The German dossier must still address national elements such as:
- target population,
- epidemiology,
- treatment costs,
- quality-assured use,
- German comparator requirements,
- and additional national analyses.
Why does AMNOG legislation matter during clinical development?
AMNOG legislation affects the evidentiary value of a clinical development programme before the medicine reaches the German market.
Legal requirements concerning the comparator, patient-relevant benefit and population structure have direct consequences for trial design.
A development programme should therefore examine:
- whether the comparator can support the German assessment,
- whether the study population matches the anticipated indication,
- whether endpoints measure legally relevant patient benefit,
- whether subgroup evidence will be available,
- and whether the necessary analyses can be completed for dossier submission.
The AM-NutzenV states that marketing-authorisation studies generally form the basis of the initial assessment. It also permits the G-BA to require further evidence where the authorisation studies are insufficient. (Gesetze im Internet)
The pivotal study should therefore not be treated as automatically sufficient for AMNOG. This point is also explicit in the supplied training material.
What does AMNOG legislation mean for international Market Access teams?
International Market Access teams must distinguish the German legal framework from both regulatory approval and the European JCA.
Four points are particularly important.
Germany applies a national comparative standard
The appropriate comparator therapy reflects the German care situation. It may differ from the global clinical comparator or from comparators considered in other HTA jurisdictions.
The authorised indication drives the legal assessment scope
The final wording of the indication can determine:
- patient populations,
- comparator selection,
- evidence eligibility,
- and the structure of the G-BA resolution.
Changes between the anticipated and final indication may therefore have consequences for the national assessment.
The G-BA resolution is population-specific
The G-BA may adopt different added-benefit conclusions for different patient groups. A broad authorisation does not ensure one uniform assessment result.
European clinical assessment does not remove national pricing law
EU HTA may reduce duplication in the clinical evidence assessment, but reimbursement negotiation remains governed by Section 130b and related German rules.
AMNOG legislation connects evidence, benefit assessment and reimbursement
AMNOG legislation establishes a legally structured path from clinical evidence to a national added-benefit decision and then to reimbursement-price negotiation.
Section 35a SGB V creates the benefit-assessment obligation. The AM-NutzenV defines the assessment standards. The G-BA Rules of Procedure specify the dossier and procedural requirements. Section 130b governs the reimbursement agreement.
For manufacturers, the practical significance extends beyond legal compliance. The framework determines whether clinical evidence can support the German comparator, relevant populations and patient-relevant outcomes.
Under EU HTA, this national framework remains in place. The strategic task is to use the European clinical evidence base while still satisfying the legal requirements of the German benefit assessment and reimbursement process.
Frequently asked questions about AMNOG legislation in Germany
What law introduced AMNOG?
AMNOG was introduced through the Arzneimittelmarktneuordnungsgesetz and took effect in 2011. Its current operational rules are primarily embedded in the SGB V, the AM-NutzenV and the G-BA Rules of Procedure.
What is Section 35a SGB V?
Section 35a SGB V is the main statutory provision governing the early benefit assessment of reimbursable medicines with new active substances.
What is the AM-NutzenV?
The AM-NutzenV is the German ordinance specifying the principles and requirements of the benefit assessment under Section 35a SGB V.
What is Section 130b SGB V?
Section 130b SGB V governs reimbursement agreements between the GKV-Spitzenverband and pharmaceutical companies following the G-BA benefit resolution.
Which medicines are subject to AMNOG legislation?
AMNOG generally applies to reimbursable medicines with new active substances or new combinations, including assessments triggered by new indications or reassessment requirements.
What happens if the dossier is incomplete?
If the required evidence is not submitted on time or remains incomplete despite a G-BA request, added benefit is deemed not proven under Section 35a SGB V.
Is an orphan medicine exempt from AMNOG?
No. Orphan medicines undergo an AMNOG benefit assessment under a special statutory rule. A regular comparative assessment applies after the statutory €30 million turnover threshold is exceeded.
Who decides the added benefit?
The G-BA adopts the legally relevant resolution on added benefit. IQWiG generally prepares the preceding scientific assessment.
Does the G-BA set the price?
No. The G-BA decides on added benefit but does not directly set the reimbursement amount. The GKV-Spitzenverband and the pharmaceutical company negotiate the amount under Section 130b SGB V.
Does EU HTA replace AMNOG legislation?
No. EU HTA does not replace the national German added-benefit resolution or reimbursement negotiation. The European clinical assessment is incorporated into, but does not displace, the German legal framework.