How Much Does It Really Cost to Launch a Pharma Product in France?

Sep 9, 2025

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Expanding into the French market is a major milestone for pharmaceutical and biotech companies. France is not only one of the largest healthcare markets in Europe but also a strategically important entry point for EU commercialization.

Yet one of the first questions every executive team asks is:
“How much will it cost us to launch in France?”

The short answer: it depends. The cost of launching in France varies widely depending on your product type, regulatory pathway, and the level of support you need from your Exploitant (the French legal representative responsible for your product on the market).

In this post, we’ll break down the main cost drivers and show you how to estimate your budget.

1. Exploitant Setup & Responsibilities

Every company commercializing medicines in France must appoint an Exploitant. This entity holds critical responsibilities, including:

Pharmacovigilance & safety reporting
Batch release and compliance
Advertising & promotion oversight
Regulatory submissions to ANSM

👉 Costs here vary depending on whether you need basic coverage (address, QP, compliance) or full service (pharmacovigilance, reporting, audits, etc.).

2. Marketing Authorisation (MA) Transfer

If your product already has an EU MA, you’ll need to transfer it to your French Exploitant.

With EU MA: Lower costs, faster timelines
Without EU MA: Higher costs (regulatory support, dossier updates, local requirements)

3. Market Access & Pricing

France is highly regulated when it comes to pricing and reimbursement. Preparing a dossier for CEPS (pricing negotiations) or navigating HAS assessments (value demonstration) can add significant costs.

For innovative or orphan products, this step is essential to success.

4. Distribution & Supply Chain

Will you need:

Local warehousing?
Temperature-controlled logistics?
Direct-to-hospital distribution?

Each choice affects your budget.

5. Timeline Considerations

Your desired time-to-market has a direct impact on costs.

Launching in <6 months may require premium support (faster setup, more resources).
Longer timelines allow for staged investment.

🎯 Typical Cost Range

From our experience, companies should expect launch costs to range from:

€50,000 – €80,000 for generics/OTC with basic support
€100,000 – €200,000+ for innovative/orphan drugs requiring full exploitant, market access, and distribution setup

🚀 Try Our Free Calculator

Want to know your number?
Elliogen has created the France Launch Cost Calculator — a quick, interactive tool that gives you a personalized estimate in 3 minutes.

👉 Estimate Your France Launch Cost Now: https://elliogen.com/cost-calculator/

Why Elliogen?

We help international pharma and biotech companies:

Select the right exploitant partner
Navigate ANSM, HAS, and CEPS
Optimize market access strategies
Avoid costly delays and compliance risks

Ready to enter France with confidence?
Contact us today for a tailored consultation.