Paragraph 1: Provisions relating to the entry into national territory of the elements or products of the human body mentioned in Article R. 1245-1 when they are not authorised in the Member State of origin

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R1245-15R1245-16

Article R1245-16

French Public Health CodeIn force
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Updated 5 Nov 2023

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

II. - He may request any additional information he considers necessary, by any means capable of providing a definite date for this request. In this case, the time limit stipulated in the previous paragraph is suspended until the additional information required has been provided.

III. - If no response is received by the end of this period, the request is deemed to have been rejected.

IV. - Authorisations specify the category of products entering the national territory.

V. - Authorisations issued in this way may be modified, suspended or withdrawn in whole or in part by the Director General of the Agence nationale de sécurité du médicament et des produits de santé under the conditions laid down in Article L. 1245-1. A copy of decisions to authorise, suspend or withdraw authorisations is sent to the Minister for Health, the Minister for Customs and the Agence de la biomédecine.

VI. - Any modification of the information contained in the initial application for authorisation, concerning the nature or origin of the products as well as the substantial modifications mentioned in 4° of Article R. 1243-7 is subject to authorisation issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The application for modification is submitted and examined under the same conditions as the initial application.

VII. - Any change to the other elements included in the initial dossier must be declared to the Director General of the Agence nationale de sécurité du médicament et des produits de santé within one month of its implementation.

VIII. - The Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorised establishments or organisations, giving the names and addresses of these establishments or organisations and the category of products that each of them is authorised to obtain. This list is accessible to the public on the Agency's website.

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

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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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