You have the marketing authorisation. You may even have a reimbursed price. Now someone has to sit in front of French doctors and pharmacists and explain why your product matters. For most international companies this is where the French launch plan goes quiet, because building a field team in France works differently from the US, the UK or Germany.
This guide covers what you need to know before you put a single representative in the field: the rules, the roles, the realistic options, and the order in which to do things.
1. Accept that promotion in France is a regulated activity, not just a sales function
In France, promoting a prescription medicine is tied to the exploitant, the pharmaceutical establishment that carries legal responsibility for the product on the French market. The exploitant's Responsible Pharmacist (Pharmacien Responsable) is personally accountable for promotional activity, alongside pharmacovigilance, batch tracking and recalls.
In practice, that means your sales team cannot operate as a free-standing commercial unit. Every visit, every leave-behind and every congress stand has to sit inside the exploitant's compliance framework. If you have not yet sorted out who your exploitant is, do that first. Our guide on how to choose the right exploitant is a good place to start.
2. Get your promotional materials approved before you need them
This is the step that catches most international teams out. Since the 2011 Loi Bertrand on medicines safety, advertising for medicines aimed at healthcare professionals needs prior approval from the ANSM, the French medicines agency. The approval is called a visa PM.
- Submissions only open during set windows published by the ANSM each year. Miss one and you wait for the next.
- Review takes around two months after the window closes.
- A visa is valid for two years, after which it must be renewed.
- Each application carries a fee, and the ANSM checks that materials match the marketing authorisation and the HAS's recommended treatment strategy, present the product objectively and are not misleading.
What this means for you: your global detail aid cannot simply be translated and used. Work backwards from your launch date, and plan your core materials at least four to six months ahead so they can go through a submission window.
3. Make sure your promotion can be certified
France has a formal certification scheme for promotional activity. The HAS (the national health technology assessment body) publishes a reference framework, and companies that promote medicines through representatives (information par démarchage ou prospection) are audited against it by independent certification bodies accredited by COFRAC. Certificates run on a three-year cycle with surveillance audits in between.
The framework covers how representatives are trained, what they can say and hand over, how often they can visit, how activity is documented and how quality is monitored. Your team needs to be trained on it from day one, and the processes need to exist before the first visit, not after the first audit.
4. Know the rules on interactions with healthcare professionals
Two separate sets of rules govern what your team can give to, and agree with, French healthcare professionals:
- The anti-gift rules (loi anti-cadeaux). Offering benefits to healthcare professionals is prohibited in principle, with defined exceptions such as hospitality at scientific meetings or fees for genuine services. Many permitted arrangements must be declared to, or authorised by, the relevant professional body before they take place.
- Transparency (Transparence Santé). Agreements with healthcare professionals, and any benefits or payments of €10 or more, must be published on the public Transparence Santé database.
French authorities enforce these rules. A pharmaceutical group was fined over €1 million in 2023 over benefits given to community pharmacists. Advisory boards, speaker fees and congress sponsorship all need a process, and your global SOPs are unlikely to cover the French specifics. It is one of the most common mistakes companies make when entering France.
5. Decide which roles you actually need
Not every launch needs a national field force. Match the team to the product and the customer:
- Medical representatives (visiteurs médicaux) for GP and specialist promotion in the community. French law requires them to hold a recognised professional qualification.
- Key Account Managers (KAMs) for hospital products, where decisions are made by pharmacy committees, purchasing groups and department heads rather than individual prescribers.
- Medical Science Liaisons (MSLs) for scientific exchange with key opinion leaders. MSLs sit in the medical function and must stay non-promotional, which makes them especially valuable before launch and during early access.
- A country manager to own the French P&L, coordinate the exploitant, market access and field teams, and represent you in pricing discussions.
A rare-disease product with 30 expert centres might need two MSLs and one KAM. A primary-care product might need a national team of 40. Getting this wrong in either direction is expensive. For the wider launch budget, try our France Launch Cost Calculator.
6. Choose between hiring, outsourcing, or a mix
You have three realistic options.
Hire directly
You get full control and long-term capability. But you also need a French legal entity, French employment contracts, a collective bargaining agreement and payroll. Recruiting takes months, and French employment law makes it slow and costly to scale down if the launch underperforms.
Use a contract sales organisation (CSO)
A CSO provides trained, qualified representatives, KAMs and MSLs who work exclusively on your product. The CSO is the employer, so you avoid setting up a French entity and the fixed cost that comes with it. A good CSO can field a team in weeks rather than months, and can scale it up or down as the launch develops. Teams are typically supported by the CSO's own training, CRM and compliance infrastructure.
Combine them
Many international companies start with a CSO and hire a small core team (often a country manager and a medical lead) directly. Once the product proves itself, they may bring the field force in-house. This keeps fixed costs low during the riskiest period of the launch.
7. Join the pieces up
The most common failure we see is not a bad sales team. It is a sales team working in isolation: materials still waiting for ANSM approval, an exploitant that was not consulted, a market access story that does not match what representatives say, and nobody tracking Transparence Santé declarations.
The smoothest French launches are run with a single coordinated set-up, where exploitant, regulatory, market access and promotion work from one plan. That is far easier when they sit with partners who already work together, rather than four suppliers who have never met.
A quick checklist before your first field visit
- Exploitant in place, with a Responsible Pharmacist signed up to oversee promotion
- Core promotional materials approved by the ANSM (visa PM)
- Promotional processes ready for HAS certification, and representatives trained on them
- Anti-gift and Transparence Santé processes set up for France
- Team structure matched to the product: reps, KAMs, MSLs, country manager
- A decision on hiring, outsourcing to a CSO, or a hybrid
- Promotion, market access and medical messaging aligned
Why Elliogen?
Through our French partner network, Elliogen can put in place the full commercial set-up for your launch: exploitant and Responsible Pharmacist, regulatory and compliance support, market access, and promotion through France's leading contract sales organisation, which can supply medical reps, KAMs, MSLs and country managers. You get one point of contact and a team that already works together.
If you are planning a French launch, or your current one is not getting traction in the field, we'd love to talk. We will tell you what your launch actually needs, and what it doesn't.
👉 Book a Free 20-Minute Consultation or email us at hello@elliogen.com
FAQ
- Can a foreign company promote a medicine in France without a French entity? Promotion has to run under a French exploitant. Many companies use a third-party exploitant together with a CSO, so they don't need to set up their own entity.
- Can I use my global promotional materials in France? Not as they are. Materials aimed at healthcare professionals need an ANSM visa PM, and they must reflect the French marketing authorisation and HAS recommendations.
- How quickly can a CSO field a team? It depends on team size and profile, but usually much faster than direct hiring. Materials approval and training are often what decide the start date.
- Are MSLs allowed to promote? No. MSLs carry out non-promotional scientific exchange and should sit within the medical function, separate from sales.