Subsection 2: Authorisation procedure

Articles in this section · 8

R1243-4R1243-5R1243-6R1243-7R1243-8R1243-9R1243-10R1243-11

Article R1243-6

French Public Health CodeIn force
Ask for lawyer reviewed or certified translation

Updated 5 Nov 2023

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within four months of the date on which the application is deemed to be complete.

If the Director General considers that additional information is required to enable him to reach a decision on the application, he may suspend consideration of the application until the missing information has been received, subject to a maximum period of four months. In this case, it must notify the applicant of the reasons for the interruption and specify the deadline by which the information must be sent. This request for additional information suspends the period mentioned in the first paragraph.

If no decision has been taken by the end of this period, the application will be rejected.

The authorisations specify the address of the establishment or organisation and, where applicable, that of the site, the type of activities authorised, the category of tissues and their derivatives, cells or cell therapy preparations, mention the agreements entered into between an establishment and third parties for the performance of these activities, the preparation and preservation processes used and the recognised therapeutic indications. They also mention, where applicable, the specific authorisation provided for in I of Article R. 1243-3-1.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé sends the authorisations granted to the Director General of the Agence de la biomédecine and to the Director General of the regional health agency within whose jurisdiction the authorised establishment or site is located.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorised establishments or organisations, indicating the activities for which each establishment or organisation has been authorised and the tissues, their derivatives, cells or cell therapy preparations to which these activities relate. This list is accessible to the public.

Mariela Petrova

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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

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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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