PHARMA · MARKET ACCESS · GERMANY

Getting authorized is the ticket. Getting reimbursed is the work.
For an international pharmaceutical company, the German question is rarely “can we sell here.” It’s “will it be reimbursed, at what price, and who carries the relationship.” We help you answer that before you commit the budget to it.
Book a market assess session
See how reimbursement works
G-BA

FEDERAL JOINT COMMITTEE
IQWiG

BENEFIT ASSESSMENT
GKV-Spitzenverband

PRICE NEGOTIATION

— THE REAL PROBLEM

Germany is among the largest pharmaceutical markets in Europe and, for most companies, the first serious step into the EU. But a marketing authorization is only the entry ticket.

Commercial success is decided downstream — in the reimbursement decision, the negotiated price, the distribution channel and the local relationships that German payers, wholesalers and hospitals expect. Getting authorized and getting paid are two different projects, and most market-entry failures happen in the gap between them.

Medical devices, diagnostics and digital health follow a different regulatory and reimbursement logic (MDR, CE, DiGA). We keep those as separate tracks rather than fold them into pharma — the separation is itself a signal that the detail matters here.
— WHAT SETS YOUR CEILING

The reimbursement process below sets the ceiling on German revenue and it should shape positioning and evidence from day one, not after launch.

— AMNOG · THE REIMBURSEMENT PATHWAY

The decision that actually shapes your launch

A new patented medicine enters the German statutory market through AMNOG. This single sequence — not your sales effort — decides what Germany will pay.

Free launch price
You set your price freely for the first months on the market — the only window of full pricing freedom you’ll have.
Benefit dossier to the G-BA
You submit an added-benefit dossier to the Gemeinsamer Bundesausschuss (Federal Joint Committee), the gatekeeper of the statutory benefit catalogue.
IQWiG assessment
The institute assesses your product’s added benefit (Zusatznutzen) against a defined comparator (zweckmäßige Vergleichstherapie). Your comparator choice is a strategic decision, not an administrative one.
Price negotiation
The GKV-Spitzenverband negotiates the reimbursement amount with you, based on the assessed benefit.

  • ADDED BENEFIT SHOWN

    Negotiated reimbursement price

    A defined Erstattungsbetrag that can support a premium — if the benefit case was built early.

  • NO ADDED BENEFIT

    Reference price (Festbetrag)

    Assignment to a reference-price group — a hard ceiling on what Germany will pay.

— THE Entry ticket

Regulatory authorization

  • ROUTE

    How the product gets in

    Most innovative and biological products reach Germany through the EMA centralized procedure; others via national authorization through BfArM — and PEI for vaccines, blood products and biologicals — or mutual-recognition and decentralized routes.

  • OBLIGATIONS

    What you carry as MAH

    Pharmacovigilance (QPPV), a graduated-plan officer (Stufenplanbeauftragter), an information officer, advertising compliance under HWG and the FSA codes, and GMP/GDP across the supply chain.
We coordinate this with specialist regulatory and pharmacovigilance partners — we don’t pretend to be your regulatory affairs department. We make sure it’s in place and aligned with the commercial plan.

— CHANNEL

Distribution & supply

  • WHOLESALE

    Full-line wholesalers

    Prescription supply runs through Phoenix, Alliance Healthcare/Gehe, Sanacorp and Noweda into roughly 18,000 community pharmacies — under GDP and EU serialization (securPharm / FMD).

  • HOSPITAL

    Tenders & hospital pharmacies

    Hospital supply runs through hospital pharmacies and tender procedures; the statutory generics market runs largely on rebate contracts (Rabattverträge).

  • FIT

    Channel follows product

    Patented hospital specialty, retail Rx, biosimilar or generic — each implies a different partner, a different commercial motion and a different conversation.

— COMMERCIAL MODEL

Choosing how you enter

  • Distribution / licensing partner

    First entry; no German affiliate yet

    Fastest access, lowest fixed cost, least control

  • Co-promotion partner

    Shared KAM into hospitals & specialists

    Shared economics, shared control

  • Own German affiliate (GmbH)

    Long-term presence, pipeline, brand

    Full control, full cost — justified by volume

  • Interim local representation

    Testing the market before committing

    A named local presence without an affiliate first

— HOW WE WORK

What we own — and what we coordinate

  • — SCOPE OF WORK

    • Market & pricing-environment read
    • Positioning & comparator narrative framing
    • Identification and approach of distribution / licensing partners
    • Local representation in payer, partner & hospital conversations
    • Orchestration of the specialists into one plan

  • — WE coordinate, not replace

    • The IQWiG / G-BA benefit dossier
    • Regulatory submissions
    • Pharmacovigilance setup
    • Legal contracts
    Executed with specialist partners, kept aligned to the commercial goal and your timeline — so nothing falls between the desks.
A boutique that claims to do AMNOG dossiers, regulatory affairs, distribution and law all in-house isn’t credible to anyone who has launched a drug in Germany. Owning the commercial and relationship layer, and orchestrating the rest, is.

— proof

Why teams trust us with the German step

  • — TRACK RECORD

    Alexander Baranov
    Market Access & Regulatory Affairs Lead — 15 years

    Bringing generics and biosimilars onto regulated markets across the EU, Canada and Korea — registration pathway, government-level market-entry roadmap, and all the unglamorous paperwork: CTD/eCTD dossiers, responses to deficiency letters, pricing & reimbursement at launch.

  • — AUTHORITIES NAVIGATED

    • Germany. Generics & biosimilarsBfArM · PEI
    • Austria. National / MRPBASG · AGES
    • France. National / DCPANSM
    • Canada. Biologics & genericsHealth Canada
    • South Korea. BiosimilarsMFDS · NIFDS
    EU-level coordination via EMA — centralized & decentralised procedures.

— START HERE · LOW RISK


Germany market Access Assessment

A focused working session plus a short written output — so you know the realistic German picture before committing budget.


  1. A realistic reimbursement scenario (AMNOG added-benefit vs Festbetrag)
  2. The recommended commercial model and channel
  3. A partner / distributor shortlist
  4. The regulatory & PV gaps to close before launch
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