Subsection 3: Conditions for authorisation.

Articles in this section · 8

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

Article R1243-15

French Public Health CodeIn force
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Updated 5 Nov 2023

I.-The applicant establishments or organisations have medical, paramedical and technical staff who carry out their duties under the authority of the person in charge or the person responsible for the activities mentioned in article R. 1243-12. These establishments have at least :

1° A person responsible for preparation. Only persons who, on the one hand, satisfy the conditions for practising medicine or pharmacy, or hold a doctorate in the field of life and health sciences or an engineering degree, and who, on the other hand, can justify the conditions of professional experience, the terms of which are specified in an order of the Minister in charge of health, may perform this function. Persons holding a diploma entitling them to practise the profession of medical laboratory technician within the meaning of Articles L. 4352-2 and L. 4352-3 may also carry out this function, provided that they meet the conditions laid down in the aforementioned order and have received a favourable opinion from the person in charge referred to in Article R. 1243-12 ;

2° A quality control manager. Only persons who, on the one hand, satisfy the conditions for practising medicine or pharmacy, or hold a doctorate in the field of life and health sciences or a national master's degree in the field of life and health sciences and who, on the other hand, can justify the conditions of professional experience, the terms of which are specified in an order of the Minister for Health, may perform this function. Holders of an engineering degree may also perform this function provided they meet the conditions set out in the aforementioned order and have received a favourable opinion from the person in charge referred to in article R. 1243-12.

II -There must be sufficient paramedical and technical staff to carry out the activities mentioned in article L. 1243-2 during the opening hours of the establishment or organisation making the request. However, in order to respond to emergency situations and when the nature of the tissues, their derivatives or cell therapy preparations justifies it, their distribution is possible outside opening hours.

III - As part of their duties, the staff mentioned in I must comply with the good practices defined in application of article L. 1245-6.

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.

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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.

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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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Toque #C2396

15+ Years In Corporate Practice

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