Section 2: Implementation of financial penalties

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Article R5312-2

French Public Health CodeIn force

Updated 1 Nov 2023

I - On the basis of inspections carried out in application of the provisions of Article L. 5313-1, the results of controls or evidence of breaches observed under Articles L. 5471-1 and R. 5471-1, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may initiate financial sanction proceedings against those responsible for these breaches.

II - The Director General of the Agency will inform the natural person or legal entity concerned of the facts justifying the initiation of the sanction procedure and the breaches observed, the financial sanction incurred and will provide it with the information justifying these breaches. It:

1° Gives the natural or legal person concerned the opportunity to present its observations, in writing or orally, with an indication of the possibility of being assisted by counsel;

2° Where appropriate, gives it formal notice to rectify the situation;

3° Gives it formal notice to transmit the turnover constituting the basis for the financial penalty.

It sets the person concerned a period of not less than eight days in which to comply with the requests mentioned in 1° to 3° above. When using 2°, this period may be reduced in urgent cases.

III - Once the deadline has expired, the Director General of the Agency may impose a financial penalty.

If the person concerned has not regularised the situation within the time limit set, this penalty may be accompanied by a daily penalty, which will begin to run from the date of notification to the person concerned of the financial penalty and which will cease to run on the day the situation is regularised, where applicable, as established by a new inspection.

IV - The person concerned will be notified of the decision to impose the sanction by any means that can be relied upon to provide a date certain. It shall indicate the nature of the facts constituting the breach, the amount of the penalty imposed and, where applicable, the periodic penalty payment, the terms of payment and the appeal procedures and deadlines.

V. - The decision to impose a financial penalty may be published on the Agency's website for a period not exceeding one month or, where applicable, until the situation has been rectified, if this has not occurred by the end of this period.

Mariela Petrova

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Working with a corporate lawyer in France — Q&A

Any time a strategic decision changes how the company is owned, governed or contractually bound — incorporation, fundraising, M&A, restructuring, shareholder agreements, or major commercial contracts. Earlier engagement always costs less than later remediation.

A notary (notaire) is a public officer who authenticates specific deeds (mainly real-estate transfers and certain family-law acts). A corporate lawyer (avocat) advises on strategy, negotiates and drafts company documents, and represents you in disputes. The two roles complement rather than overlap.

Yes — most of our clients are foreign suppliers, investors or holding entities. We bridge the gap between French law and your home jurisdiction's expectations and deliver everything bilingually.

The SAS (Société par Actions Simplifiée) is the default choice for most international structures: flexible governance, single shareholder allowed, no minimum capital, and works cleanly with foreign holding entities. We assess SARL, SA, SCI on the merits when the situation calls for it.

Yes — communications with a French avocat are protected by the secret professionnel (Article 66-5 of the Law of 31 December 1971). This protection is broader than the common-law attorney-client privilege and applies to written and oral exchanges.

We work on fixed fees for clearly scoped engagements (incorporation, contract drafting, audits) and on monthly retainers for ongoing advisory. Hourly billing is the exception, not the default. You always know the cost before work starts.

Typical timeline is 2–3 weeks from KYC kick-off to RCS registration, assuming standard documentation. Holding-company structures, foreign-shareholder identification or in-kind contributions can extend this — we flag the gating items at the first meeting.

Absolutely. We routinely coordinate with your in-house counsel, expert-comptable or notaire — pragmatic collaboration is the norm, not the exception. We send them everything they need to do their part without duplicating work.

Mariela Petrova

Mariela Petrova

Avocate au Barreau de Paris

Toque #C2396

15+ Years In Corporate Practice

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Communications protected by professional secrecy — secret professionnel de l'avocat, Article 66-5 of the Law of 31 December 1971.

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