Section 1: Scope and definitions

Articles in this section · 19

Article R5124-6

French Public Health CodeIn force

Updated 2 Nov 2023

The authorisation to open, provided for in the first paragraph of Article L. 5124-3, a pharmaceutical establishment, a company or a body mentioned in Article R. 5124-2 is issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the competent Central Council of the Ordre national des pharmaciens and after an administrative enquiry by one of the Agency's agents, which may take the form of an on-site enquiry by an inspector mentioned in Articles L. 5313-1 and L. 5313-3.

If the Central Council has not given its opinion within two months, the Director General may take a decision.

The opinion of the Central Council is not required for authorisation to open a pharmaceutical establishment dependent on the central pharmacy of the armed forces or the medical supply establishments of the armed forces health service.

Opening authorisations granted to a company or organisation are recorded in the European Union database, in accordance with article 40 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

Mariela Petrova

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Common Questions

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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