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How Much Does It Really Cost to Launch a Pharma Product in France?
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:âHow much will it cost us to launch in…
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Launch Planning in Pharma: Why Patient and Stakeholder Mapping Matters More Than Ever
Bringing a new therapy to market is one of the most complex and high-stakes undertakings in the pharmaceutical industry. Success is not only about regulatory approval or strong clinical dataâitâs also about ensuring the product is launched into an environment that is prepared, receptive, and aligned with patient needs. Thatâs where patient and stakeholder mapping,…
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Understanding the “NS” Mention in France: What Pharmaceutical Companies Need to Know
Launching and commercializing medicines in France requires navigating a complex regulatory and market access environment. One area that often raises questions among pharmaceutical professionals is the âNSâ (Non Substituable) mention, which directly affects prescribing and dispensing practices. What is the NS mention? The NS mention allows prescribers in France to indicate that a prescribed medicine…
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FAQ: The Role of the âExploitantâ in the Pharmaceutical Industry
1. What is an âExploitantâ? In the French pharmaceutical regulatory system, the Exploitant is the legal entity responsible for placing a medicinal product on the French market. It is the entity recorded on the Marketing Authorization (MA) that ensures the product complies with all regulatory, pharmacovigilance, and distribution obligations in France. 2. Is the exploitant…
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Understanding the Reimbursement Process for Prescription Medicines in France
Launching a prescription medicine in France requires more than just obtaining marketing authorization. To ensure patients can access your product â and the French health insurance system (Assurance Maladie) covers its cost â youâll also need to navigate the reimbursement process. Hereâs a step-by-step guide to how it works. đ Step 1: Obtain Marketing Authorization…
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How to Choose the Right Exploitant in France: A Practical Guide
When launching a prescription medicine or medical product in France, one of your first and most important decisions is selecting an exploitant. In the unique French regulatory framework, the exploitant is the legal and regulatory entity responsible for placing the product on the market. They hold the marketing authorization, ensure compliance with ANSM requirements, manage…
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How to Bring Your Drug to French Patients Before Approval: Compassionate Use & AccÚs Précoce Explained
If your company is developing a new medicine and youâre looking at France as part of your European launch, you might wonder:đ âIs it possible for patients in France to access our drug before we get full marketing authorisation?â The good news: yes, it is possible â thanks to two special early access pathways. These…
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What is an Exploitant in France and why you might need one?
The Exploitant: Your key to the French market In France, an âExploitantâ plays a crucial role for any company entering the pharmaceutical market. This legal status allows pharmaceutical companies to import, market, and sell medical products within France. More than just a permit, it acts as your companyâs local representative, ensuring all products meet Franceâs…
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Your 2026 Guide to Pharma Market Access in France
France remains one of the most attractive yet challenging pharmaceutical markets in Europe. With a highly regulated environment, price controls, and a centralised reimbursement system, successfully launching and sustaining your product in France requires a solid understanding of the market access landscape â and how itâs evolving in 2026. Why France? Franceâs single-payer system ensures…
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White Paper : Navigating the French Pharmaceutical Market
A Comprehensive guide to explore the French MarketUnderstanding the role of Exploitant Introduction The French pharmaceutical market is one of the most complex and highly regulated in Europe, yet it offers substantial opportunities for growth and development. Understanding the local regulatory landscape is essential to ensure successful market entry. A pivotal aspect of this landscape…
