|French always do it different In many domains, French people like to stand out, either in a positive or negative way. In the Healthcare field, France has set a system that is highly effective, and very protective for the patient, but at the price of a heavy state involvement and of one of the most complex regulations. As a result, understanding the regulatory specificities of France is key for entering the French market. ATESSIA can help you in this process and provide you assistance and expertise. Here are a few areas where France follows its own, often complicated and restrictive, rules.|
If you’ve ever worked in a pharmaceutical company that has a subsidiary in France, there’s almost 100% chances that you haveheard about this absolutely unique-in-Europe status for a pharmaceutical establishment. So what does this mean and why are requests coming from French affiliates always so weird?
What is an Exploitant?
The term itself is so difficult to translate in a satisfactory way that it is almost always referred as “Exploitant” (with French accent, please).
The Exploitant is a distinct status from the MA Holder (however, they can be the same company) and cannot be defined as a distributor as well. Proof is, that WDAs issued by ANSM will not mention procurement/selling, but rather “Other – Exploitation”.
As long as there is a Marketing Authorization or an early access program in place (such as Early Access or Compassionate Use), no medicinal product can be distributed in France without an Exploitant being responsible for it.
The exploitant’s scope of activities covers:
- Wholesaling – This means that the Exploitant is the one allowed to sell products to the rest of the distribution chain
- Promotional activities – The Exploitant is the only entitled to use advertising material (under strict rules anyway)
- Medical information – The Exploitant is responsible for providing necessary information to requestors, mainly prescribers, under stringent rules.
- Pharmacovigilance – The Exploitant in the main contact for French agency
- Batch follow-up and, if necessary, batch recall
- Storage, if applicable
After this listing you may think that the Exploitant is responsible for almost everything, but the MA Holder still has certain responsibilities, and some are shared, like pharmacovigilance for example.
Some of the Exploitant duties (although not all) can be partly of completely subcontracted, but still fall under its supervision and responsibility. In case of subcontracting, the Exploitant will have to ensure that everything is done right.
In addition, the Exploitant is also the key when it comes to Market Access, Sales Reps Certification and pharmaceutical taxes.
Exploitants need to be authorized by ANSM prior to opening, and are regularly inspected, potentially financially sanctioned and can be closed by ANSM decision if any risk for Public Health.
Who’s the Responsible Pharmacist?
No matter how you call him/her (Chief Pharmaceutical Officer, and most often PR for “Pharmacien Responsable” in Molière’s language), he/she is the master person of an Exploitant. The one that personally undertakes all responsibilities, all sanctions.
The PR is necessarily a French Pharmacist, residing and working in France with a special level of experience that has to be recognized by the Order for Pharmacists.
How to enter the French Market and get your products “exploited”?
Securing a Marketing Authorization in France is a good start and an obvious prerequisite for entering the French Market indeed, but the having your product “exploited” is another key step.
You could either open your own Exploitant as your French subsidiary or rely on an already existing structure for exploiting your product.
Opening an Exploitant requires expertise in the following areas:
- Describing the future Quality Management System. The QMS must be sufficiently described in order for ANSM to understand precisely enough how the Exploitant will operate and how it will handle a series of pharmaceutical operations like promotion, batch follow-up, pharmacovigilance;
- Finding premises, and presenting related documentation as well as physical and IT securities in a way that will meet ANSM’s requirements;
- Hiring a Responsible Pharmacist;
- Managing all of the above in French, as the application file and relationships with the Authority can only be done in French;
- Contracting Quality Agreements with partners (e.g. MAH) and sus-contractors (e.g. wholesaler) that meet French & EU regulation;
- Certifying promotional activities within 9 months after the beginning of promotion.
Whatever the scenario, ATESSIA opened several Exploitant in France and can help you in defining your strategy, building you Exploitant opening file, or arranging third-party exploitation.
Article written by Raphaël DAUVERGNE, Regulatory and Pharmaceutical Affairs Advisor