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SummaryPharmaceutical market access in Germany is a two stage path: a medicine first needs a marketing authorisation, granted either EU wide through the EMA centralised procedure or nationally by BfArM or the Paul-Ehrlich-Institut, and it then has to earn a reimbursed price through the AMNOG procedure, in which the G-BA assesses the added benefit and the manufacturer negotiates an Erstattungsbetrag with the statutory health insurance funds. Approval alone lets you sell in Germany from day one at a price you set yourself. It does not secure the price you keep.
Most English language guidance treats these two stages as separate worlds. Regulatory affairs content explains the EU authorisation routes and stops at approval. Market access content starts at the AMNOG dossier and assumes the authorisation is already in hand. For a company planning a German launch, that split is exactly the wrong shape, because the clock that decides your long term price starts running on the day of approval, and several of the decisions that determine the outcome have to be made months earlier. This article walks the whole sequence in order, with timelines, and adds the layer that is genuinely new: the EU Joint Clinical Assessment.
Four authorisation routes lead into the German market, and the choice is only partly yours. For a defined list of product categories the centralised procedure is mandatory, including advanced therapy medicinal products, orphan medicines, biotechnology derived products and new active substances for indications such as cancer, HIV, diabetes, autoimmune disease and neurodegenerative disease. Everything else can go national, decentralised or through mutual recognition.
| Pathway | Competent authority | When to use it | Typical timeline |
|---|---|---|---|
| Centralised procedure (CP) | EMA (CHMP opinion), European Commission grants the authorisation | Mandatory for ATMPs, orphan medicines, biotech products and defined new active substances. Optional for other innovative products wanting one authorisation valid in all EU and EEA states. | 210 active assessment days plus clock stops for company responses, then a Commission decision within 67 days of the CHMP opinion. In practice around 12 to 15 months. |
| Decentralised procedure (DCP) | A chosen Reference Member State, with Germany represented by BfArM or PEI | Product not yet authorised anywhere in the EU and you want several member states at once. The standard route for generics and hybrids launching multi country. | Up to 210 days including clock stops, followed by a national closing phase of roughly 30 days per member state. |
| Mutual recognition procedure (MRP) | The member state that already granted the authorisation, recognised by BfArM or PEI | You already hold a national authorisation in one member state and want to extend it to Germany or other states. | 90 days for the concerned member states to recognise, plus a national closing phase. |
| Purely national authorisation | BfArM for most medicines, PEI for its product classes | Germany only launch, many established products, and traditional or well established use applications. | 210 days of assessment time excluding clock stops, in practice longer. |
The step by step description of the centralised route is published by the European Medicines Agency, and the national, DCP and MRP routes are described by BfArM.
Germany splits national regulatory competence between two federal authorities, and companies entering the market regularly address the wrong one. BfArM, the Federal Institute for Drugs and Medical Devices, is responsible for the large majority of medicinal products for human use, including small molecules, generics, hybrids and most biologicals that are not immunological.
The Paul-Ehrlich-Institut (PEI) is the competent authority for vaccines, sera, blood and blood products including recombinant ones, allergen products used for testing and therapy, tissue and stem cell preparations, monoclonal antibodies and advanced therapy medicinal products, plus immunological veterinary medicines. If your product falls into any of those classes, PEI is your national assessor, your batch release authority and your pharmacovigilance counterpart, not BfArM. Getting this wrong costs weeks of correspondence before the file even starts moving.
Germany is unusual in Europe, and this is the single most important structural fact for anyone planning a launch. There is no reimbursement gate before market entry. Once a medicine holds a valid authorisation, it can be placed on the German market immediately, it is reimbursable by the statutory health insurance system from day one, and the manufacturer sets the price freely.
That free pricing window lasts six months. It is the reason Germany is often chosen as the first European launch market: revenue starts early, and the German list price becomes a visible reference that other European systems use in their own international price referencing. It is also the reason the window is dangerous. Everything you do in those six months, and the dossier you file at launch, determines the price you will live with afterwards.
AMNOG, the Arzneimittelmarkt-Neuordnungsgesetz, requires every medicine with a new active substance to undergo an early benefit assessment. The manufacturer submits a value dossier to the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) at the point of launch. The dossier has to demonstrate added benefit against an appropriate comparator therapy that the G-BA defines, and that comparator definition, not the trial result, is the most common reason for a negative outcome.
The practical consequence of the month seven rule is a rebate liability that accrues while you are still negotiating. Revenue booked in months seven onwards at the free launch price will be clawed back to the negotiated level once the agreement lands. Finance planning that assumes twelve months of free pricing is planning against a rule that no longer exists. The G-BA publishes the procedure and all resolutions in English on its benefit assessment portal.
This is the live question, and it is poorly explained almost everywhere. Regulation (EU) 2021/2282 on health technology assessment has applied since 12 January 2025. It introduces the Joint Clinical Assessment (JCA), a single EU level scientific assessment of the relative clinical effects of a health technology, produced once and used by all member states.
The scope phases in. Since January 2025 the JCA covers oncology medicines and advanced therapy medicinal products. From January 2028 it extends to orphan medicinal products, and from January 2030 to all remaining centrally authorised medicines. The European Commission maintains the implementation detail on its Joint Clinical Assessments pages.
The critical point for a German launch: the JCA does not replace AMNOG. The regulation deliberately stops at the clinical layer. It produces no value judgement, no added benefit rating and no pricing consequence. Member states keep full competence over appraisal, added benefit conclusions and reimbursement. In Germany the G-BA still decides the extent of added benefit and the GKV-Spitzenverband still negotiates the price. What changes is the evidence input: where a JCA report exists, the manufacturer can refer to it in the German procedure instead of resubmitting the same clinical documentation, and the German dossier is being adapted to accommodate that.
Two operational consequences follow. First, the JCA runs on a PICO scoping exercise that collects the comparator questions of all member states, which means far more comparator arms than any single national process ever demanded. Second, because the JCA is timed around the EMA opinion, the evidence package now has to be ready earlier than a German only plan would suggest. The comparator work moves upstream by roughly a year.
"With EU HTA it is becoming ever more important to know which active substances are offered in which individual countries." Consultant, market access consultancy (translated from German)
That comparator question is a data problem before it is a strategy problem, and it runs in both directions: from a German product outwards to its equivalents, and from a foreign product back to the German one. How that matching actually works, attribute by attribute, is set out in our guide to EU active-ingredient registration and PZN mapping.
The Erstattungsbetrag is only one of several price forming mechanisms in Germany, and it applies mainly to patent protected products with a new active substance. Alongside it sit reference price groups (Festbeträge) for substances with therapeutic equivalents, statutory manufacturer rebates under the Social Code Book V, and selective rebate contracts (Rabattverträge) tendered by individual health insurance funds, which dominate the generics segment and determine which product a pharmacy actually dispenses. Each of these can override the others in practice. They are covered in depth in our companion article on pharmaceutical pricing in Germany.
Market entry switches on a set of continuing duties that are easy to under resource in a first launch:
Every step above depends on knowing what is actually on the market, in Germany and across the countries that reference German prices. Which comparator products exist, which are in a reference price group, which are currently in short supply, which active substance is available in which country and at what price. That information sits in different registries, in different languages, updated on different cycles.
pharmazie.com consolidates 25+ pharmaceutical databases into a single search, covering more than 50,000 German products and more than 120,000 international products across 50+ countries, including daily updated German supply shortage data with international alternatives. For market access teams building comparator sets and cross border price references, that is the most complete single answer to cross layer and cross border questions across DACH and 50+ countries, and it removes the country by country manual research that makes European evidence planning so slow. DACON has maintained this data since 1989.
This content is intended for healthcare professionals and does not constitute medical advice. Last reviewed: August 2026.
