Paragraph 2: Conditions for the departure from national territory of human body parts or products mentioned in Article R. 1245-1 when they do not have the authorisation mentioned in Article L. 1243-2

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Article R1245-18

French Public Health CodeIn force

Updated 5 Nov 2023

The Agence nationale de sécurité du médicament et des produits de santé has a period of four months to evaluate the information provided.

At the end of these maximum four months, when, in application of the last paragraph of I of Article L. 1245-5, the Director General of the Agence nationale de sécurité du médicament et des produits de santé is considering prohibiting the departure from national territory of an element or product mentioned in Article R. 1245-1 to a Member State of the European Union or party to the Agreement on the European Economic Area, he shall first notify his intention and the reasons for it, relating to the risk associated with the quality or safety of the component or product or the inadequacy of the data, to the establishment or body planning to carry out this operation.

The latter has one month to submit its observations.

Prohibition decisions must state the reasons on which they are based. They are notified by the Director General of the Agency to the Minister responsible for customs and to the establishment or organisation requesting the operation.

Any changes to the information submitted in the file provided for in Article R. 1245-17 and relating to the products or their preparation and storage processes which are likely to have an impact on the quality or safety of the product are sent to the Agence nationale de sécurité du médicament et des produits de santé and to the Agence de la biomédecine. They are assessed under the same conditions.

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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