For an international pharmaceutical company the German question is rarely “can we sell here.” It's reimbursement, price and the local relationships behind them. We help you answer that before you commit budget to it.
Germany is among the largest pharmaceutical markets in Europe and, for most companies, the first serious step into the EU.
But the commercial outcome is decided downstream — in the reimbursement decision, the negotiated price, the distribution channel and the relationships 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 run on a different track (MDR, CE, DiGA). We handle those separately — see Medtech & Diagnostics and Digital Health — rather than pretend one playbook covers both.
Not your home-market price, not your sales effort — the reimbursement decision. It should shape positioning, comparator choice and evidence from day one.
A new patented medicine enters the statutory market under AMNOG. This single process — not your home price, not your sales effort — sets the ceiling on German revenue.
You set your launch price freely for the first months after market entry — the only window before the assessment starts to bind.
You submit a benefit dossier to the Gemeinsamer Bundesausschuss (G-BA), the Federal Joint Committee that governs the statutory catalogue.
The IQWiG rates your product's added benefit (Zusatznutzen) against a defined comparator (zweckmaessige Vergleichstherapie). The comparator choice is where the case is won or lost.
The GKV-Spitzenverband negotiates the reimbursement amount (Erstattungsbetrag) — and the outcome forks:
Most innovative and biological products reach Germany via the EMA centralized procedure; others nationally. Authorization is necessary — but it is not the plan.
EMA centralized procedure for most innovative / biologics; national authorization via BfArM; PEI for vaccines, blood products and biologicals; plus mutual-recognition and decentralized routes.
Pharmacovigilance (QPPV), a graduated-plan officer (Stufenplanbeauftragter), an information officer, advertising compliance under HWG / FSA codes, and GMP / GDP across the supply chain.
We are not your regulatory affairs department. We coordinate these workstreams with specialist regulatory and pharmacovigilance partners and keep them aligned to the commercial plan — so authorization, dossier and launch don't run as three disconnected projects.
Full-line wholesalers (Phoenix, Alliance Healthcare / Gehe, Sanacorp, Noweda) into roughly 18,000 community pharmacies, under GDP and EU serialization (securPharm / FMD).
Hospital supply runs through hospital pharmacies and tender procedures; the statutory generics market runs largely on rebate contracts (Rabattvertraege) between manufacturers and sick funds.
A patented hospital specialty, a retail Rx product, a biosimilar and a generic each imply a different partner, a different commercial motion and a different conversation.
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.
Executed with specialist partners, kept aligned to the commercial goal — so nothing falls between the desks.
A focused working session plus a short written output — so you know the realistic reimbursement picture before committing budget.
Book a focused session and leave with a realistic AMNOG scenario, a commercial model and a partner shortlist.
Book a Pharma Access Assessment →