Subsection 3: Conditions for authorisation.

Articles in this section · 8

R1243-12R1243-13R1243-14R1243-15R1243-16R1243-17R1243-18R1243-19

Article R1243-12

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

Updated 5 Nov 2023

Applicant establishments or organisations appoint a responsible person who ensures compliance with the regulations relating to the quality and safety of tissues or their derivatives or cell therapy preparations, as well as one or more interim responsible persons who, for the period of replacement, are entrusted with the same powers and duties as those conferred on the responsible person and effectively exercise them for the duration of the replacement.

The person in charge is responsible for :

-ensuring that tissues or their derivatives or cell therapy preparations used for therapeutic purposes are prepared, preserved, distributed or transferred in accordance with the legislative and regulatory provisions in force;

-ensuring that the quality assurance system is set up, evaluated and updated in accordance with the rules of good practice;

-ensuring that the biovigilance system is applied.

With the exception of establishments or organisations authorised under article R. 1243-3, when an establishment or organisation carries out the activities mentioned in article R. 1243-1 on different sites, a person responsible for the activities is appointed by the person responsible for each site where the activities are carried out. Sites do not include places where storage or distribution activities are carried out under an agreement referred to in I of Article R. 1243-3-1.

For each site, the person responsible for the activities carries out the tasks mentioned in the first and second paragraphs under the authority of the person in charge. In the case of a blood transfusion establishment, this activity leader is appointed by the director of this establishment and acts under his authority. In the event of duly justified impediment, the activity leader is replaced by an acting activity leader appointed by the person in charge, who may be responsible for the activities of another site of the same establishment or organisation. For the period of the replacement, the Acting Operations Manager will be entrusted with the same powers and duties as those conferred on the Operations Manager for the site and will exercise them effectively for the duration of the replacement.

Mariela Petrova

Need help applying this article to your situation?

A registered French Lawyer explains what applies to your business — in English, fixed fee.

within 48h

Fixed Fee

Talk to a lawyer
Previous articleArticle R1243-11Next articleArticle R1243-13
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

English · French · Russian

Ready When You Are

Talk To A Corporate
Lawyer In France.

A 20–30 minute call, in English, to scope the engagement. No obligation, no preliminary fee. You will leave the call with a clear view of what the work will cover and what it will cost.

Talk To A Corporate Lawyer+33 1 84 88 31 00
First EngagementFixed Fee

Talk to a French lawyer.

Reply within 24 hours.

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

Continue Reading

Related corporate services in France

01 / Setup

Setting up a French company

Choose between SAS, SARL, SA or SCI — and structure your first French entity around how you actually plan to operate.

Read More
02 / Operating

French commercial contracts

Distribution, agency, supply, services and IP licences — drafted around the protections French law actually gives.

Read More
03 / Disputes

Business disputes & litigation

Shareholder conflicts, commercial breaches and pre-litigation strategy — handled by the same team that knows the file.

Read More