Setting-up an exploitant site in France: the actual timeframes and what it really costs

The miscalculation is almost always the same. Once a marketing authorisation has been granted, the marketing authorisation holder assumes that it has three months before it can enter the French market and begin marketing its medicine. Three months (90 days) is the official assessment period stated by the ANSM, so it seems logical to rely on it. In reality, this three-month period corresponds to just one stage of the process. The actual timeframe for setting up a marketing organisation in France is generally between nine and twelve months, once a laboratory has decided to establish one.

Carole Souchaire, co-founder of Alhena Consult, puts it bluntly: this nine- to twelve-month timeframe is almost impossible to shorten. It is precisely this discrepancy between the advertised timeframe and the actual timeframe that causes delays in the opening schedules of exploitant sites for foreign laboratories or start-ups.

 

 

What it means to ‘open an exploitant site in France

Many marketing authorisation holders only discover this French-specific requirement at a late stage. A European marketing authorisation grants the right to market medicines on the European market, but this is not sufficient to gain access to the French market under the conditions laid down by the Public Health Code. In France, in accordance with the ANSM’s recommendations, market access is primarily granted through an exploitant site, which must have a Chief Pharmaceutical Officer.

It is important to emphasise that this Chief Pharmaceutical Officer is not merely an administrative manager responsible for placing products on the market. They hold a corporate office, are involved in the company’s decision-making and bear personal liability in the field of pharmaceutical activities. The French Chief Pharmaceutical Officer puts their professional qualifications, their professional independence and their ability to say ‘no’ on the line.

This independence is not merely theoretical, and the health authorities regularly emphasise this in memos or during inspections. Despite pressure from finance departments or international parent companies – in a context where the financial stakes can be considerable – the Chief Pharmaceutical Officer has the authority to refuse the commercial release of a non-compliant product.

 

 

The actual timetable: three phases that add up

In practice, the actual timetable is divided into three stages. The first stage is the preparation of the ANSM dossier. This takes three to four months. This phase depends entirely on the laboratory and can be optimised depending on its internal organisation.

The second stage is the assessment by the ANSM. At this stage, a minimum of three months is required for the processing and approval of the application for authorisation to open an exploitant site. This is the only timeframe over which the pharmaceutical company has no control.

The third phase involves setting up the quality system (also known as the QMS – Quality Management System), organising outsourced pharmaceutical activities and drawing up contracts with service providers. Here too, three to four months are often required, even though some of the work is carried out in parallel with the assessment. Distribution, pharmacovigilance, medical information, on-call systems, quality documentation, organisation of pharmaceutical operations: none of these can be improvised.

The classic mistake, therefore, is to assume that the duration of phase 2 is the total duration.

 

 

What the ANSM application package contains

This is where the second unpleasant surprise comes in. The application package for opening an exploitant site is not simply an administrative form. It is a detailed application, a comprehensive demonstration of your ability to handle medicines in accordance with the Public Health Code (CSP) and the requirements of the French National Agency for Medicines and Health Products Safety (ANSM).

The ANSM assesses whether an organisation is well-structured and efficient. The standard application dossier must demonstrate that the pharmaceutical establishment is properly established in terms of its resources, responsibilities, workflows and procedures. Documentation must be provided on the layout of the offices (including the office dedicated to the Chief Pharmaceutical Officer), IT security, the lease agreement, the qualifications and appointment of the Chief Pharmaceutical Officer and the deputy Chief Pharmaceutical Officer, the quality system, the supply chain, pharmacovigilance, medical information, the on-call system and relations with service providers.

This is precisely why three to four months of preparation are required. The application dossier is not simply the final draft of a project that is still vague. It is a comprehensive audit carried out even before the ANSM begins its assessment or comes to check the systems during an inspection.

Read also: How should interactions with health agencies be managed?

 

 

Actual costs: set up your own business or use a temporary exploitant site?

The real issue, particularly for a start-up, is also a financial one.

On paper, opening your exploitant site may seem the more logical option. In practice, however, the cost is not insignificant. You need to factor in around 200,000 euros in costs for a Chief Pharmaceutical Officer, around 50,000 euros for outsourcing the preparation of the application dossier, plus the cost of the quality management system and the necessary service providers: distribution, pharmacovigilance, medical information, and sometimes other functions depending on the product portfolio and healthcare products.

In light of this, a temporary exploitant site often appears to be a more sensible solution initially. For around 450,000 euros a year (depending on the number and types of specialties to be operated), the start-up can rely on an existing structure, with a Chief Pharmaceutical Officer in post, established procedures, an opening authorization and a quality system already in place. The cost gap may close after two or three years, but in the short term, the temporary option is often cheaper than laboratories had anticipated.

 

The mistakes that foreign laboratories fail to anticipate

Foreign laboratories almost always underestimate the operational realities of the French market.

First mistake: believing that a single Chief Pharmaceutical Officer is sufficient. In reality, a Chief Pharmaceutical Officer cannot manage an exploitant site on their own. At the very least, they must be supported by a deputy Chief Pharmaceutical Officer and other service providers for the activities they wish to outsource.

Second mistake: thinking that the release procedure carried out elsewhere in Europe is sufficient for France. However, the French Chief Pharmaceutical Officer carries out a specific commercial release procedure, which involves checking the batch file, storage conditions, transport documents, temperature deviations and the conformity of packaging materials, amongst other things. If a batch is non-compliant, it will not be placed on the market.

Third mistake: believing that the parent company’s overall quality system can simply be copied and pasted. This is not the case. A quality management system must be established that is tailored to French requirements, particularly with regard to medical information, pharmacovigilance, supply and the pharmaceutical operations specific to the exploitant site.

 

 

Conclusion

Setting up an exploitant site in France cannot be planned in just three months. The actual timeframe is nine to twelve months, as it involves three phases: preparing the application, the ANSM assessment, and then setting up the quality system and agreements with service providers. The actual cost also requires a clear decision between two options: setting up your own organisation or using a temporary exploitant site.

If you are preparing to open an exploitant site on the French market, Alhena Consult can assist you with both the application process and the strategy best suited to your timetable, your portfolio of medicines and your market launch requirements.

Contact our team for bespoke support.

 

 

Sources

ANSM — Application package for the opening of an exploitant site
Legifrance — Public Health Code, articles relating to the Chief Pharmaceutical Officer
ANSM — Management of pharmaceutical establishments
ANSM — Submission of applications for opening authorisation