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.
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.
Not your home-market price. Not your sales effort. The reimbursement process below sets the ceiling on German revenue — and it should shape positioning and evidence from day one, not after launch.
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.
Distribution & supply
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).
Tenders & hospital pharmacies
Hospital supply runs through hospital pharmacies and tender procedures; the statutory generics market runs largely on rebate contracts (Rabattverträge).
Channel follows product
Patented hospital specialty, retail Rx, biosimilar or generic — each implies a different partner, a different commercial motion and a different conversation.
Choosing how you enter
What we own — and what we coordinate
- 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
- 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.
Why teams trust us with the German step
- Named market-access / regulatory lead + one-line credential.
- One anonymized case: origin country, product class, what was achieved, rough timeline.
- Named regulatory / pharmacovigilance partner(s) you coordinate with, if disclosable.
Germany Pharma Access Assessment
A focused working session plus a short written output — so you know the realistic German picture before committing budget.