French Business Law - French Legislation

Article R1244-5 of the French Public Health Code

November 5, 2023

In order to verify the conditions laid down in article L. 1244-2 and to enable the implementation of article L. 1244-6, the organisations, health establishments and health cooperation groups authorised for the activities mentioned in d of 1° and c and d of 2° of article R. 2142-1 keep information on the donor. The donor’s file contains: 1° The donor’s written consent, expressed in application of article L. 1244-2; 2°…

Article R1244-6 of the French Public Health Code

November 5, 2023

In order to comply with the provisions of Article L. 1244-4 : 1° For donations made before the first day of the thirteenth month following the promulgation of Law No 2021-1017 of 2 August 2021 on bioethics, the donor file mentioned in Article R. 1244-5 of this Code shall contain the number of children born as a result of the donation; 2° For donations made after the date mentioned in…

Article R1244-7 of the French Public Health Code

November 5, 2023

For the application of the provisions of article L. 2143-2, the doctor of the organisation, health establishment or health cooperation group authorised for the activities mentioned in d of 1° and c and d of 2° of article R. 2142-1 collects the data mentioned in article R. 2143-5 and sends it to the Agence de la biomédecine when the donation is used.

Article R1245-1 of the French Public Health Code

November 5, 2023

The provisions of this chapter apply to the legal and natural persons mentioned in II of article L. 1245-5 and in article L. 1245-5-1 who, for the purposes mentioned in these articles, bring tissues, their derivatives or cells from the human body, whatever their level of processing and cell therapy preparations, with the exception of gametes, into or out of national territory.

Article R1245-2 of the French Public Health Code

November 5, 2023

The legal or natural persons referred to in Article R. 1245-1 who bring into national territory elements or products of the human body referred to in that same article shall ensure : 1° That these have been removed or collected with the prior consent of the donor ; 2° That no payment of any kind has been made to the donor.

Article R1245-3 of the French Public Health Code

November 5, 2023

Any entry into or exit from national territory of the products mentioned in Article R. 1245-1, excluding transit, is subject to the affixing on the package of the information defined by order of the Minister for Health and the Minister for Research pursuant to Annex IV 1.7 of Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council concerning certain technical requirements…

Article R1245-4 of the French Public Health Code

November 5, 2023

The legal entities or natural persons mentioned in article R. 1245-1 who procure, supply, import or export for therapeutic purposes, including research involving the human person within the meaning of article L. 1121-1, elements or products of the human body mentioned in article R. 1245-1, shall not disclose any information that would enable the donor and recipient to be identified. They shall ensure compliance with the provisions of article R….

Article R1245-5 of the French Public Health Code

November 5, 2023

I. – The application for an import authorisation for therapeutic purposes, provided for in the first paragraph of II of Article L. 1245-5, is sent by the legal entities or natural persons mentioned in the same paragraph to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by any means that enables the application to be dated with certainty. The application for an…

Article R1245-6 of the French Public Health Code

November 5, 2023

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will send a copy of the dossier to the Director General of the Agence de la biomédecine, who will give his opinion within one month. If no response is received within this period, this will be deemed to be a favourable opinion. The Director General of the Agence nationale de sécurité du médicament et…

Article R1245-7 of the French Public Health Code

November 5, 2023

In particular, the authorisations specify the type of activity authorised and the category of products imported or exported and, for imported finished products, the therapeutic indications. In the case of imports, they shall also include the information listed in Annex II to Directive (EU) 2015/566. 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…

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Article R1244-5 of the French Public Health Code

Article R1244-6 of the French Public Health Code

Article R1244-7 of the French Public Health Code

Article R1245-1 of the French Public Health Code

Article R1245-2 of the French Public Health Code

Article R1245-3 of the French Public Health Code

Article R1245-4 of the French Public Health Code

Article R1245-5 of the French Public Health Code

Article R1245-6 of the French Public Health Code

Article R1245-7 of the French Public Health Code

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