French Business Law - French Legislation

Article R1211-35 of the French Public Health Code

November 5, 2023

The establishments and organisations mentioned in 3° of Article R. 1211-32 organise the implementation of the local biovigilance system, in particular by providing professionals with the tools they need to carry out their tasks of monitoring, reporting or declaring incidents and adverse reactions. The Agence de la biomédecine provides methodological tools for this purpose. The local biovigilance system sets out the procedures for informing the director of the establishment and…

Article R1211-36 of the French Public Health Code

November 5, 2023

I. – The establishments and organisations mentioned in 3° of Article R. 1211-32 appoint at least one local biovigilance correspondent and a deputy. As soon as they are appointed, the identity, status, experience and contact details of the local biovigilance correspondent and his/her alternate are communicated to the Agence de la biomédecine by the head of the structure in which the correspondent and his/her alternate perform their duties. The provisions…

Article R1211-37 of the French Public Health Code

November 5, 2023

I. – The local biovigilance correspondent is responsible for : 1° Ensuring that surveillance of incidents and adverse reactions is set up by healthcare professionals involved in the activities mentioned in 2° of I of article R. 1211-29; 2° Collecting, storing and making accessible the information communicated to it relating to incidents and adverse reactions; 3° Identifying and declaring serious incidents and unexpected adverse reactions to the Agence de la…

Article R1211-38 of the French Public Health Code

November 5, 2023

Each establishment or organisation mentioned in a or c of 3° of Article R. 1211-32, ensures that a procedure is put in place to prevent the use of the elements, products or derivatives mentioned in 1° of I of Article R. 1211-29 likely to present a quality or safety defect.

Article R1211-39 of the French Public Health Code

November 5, 2023

Without prejudice to the obligation referred to in Article L. 1413-14: 1° Any healthcare professional practising in an establishment or structure with a local biovigilance correspondent who is aware of the occurrence of a serious incident or unexpected adverse reaction must report it without delay to this correspondent or, failing this, to his deputy. If the local correspondent and his/her alternate are unable to act, the healthcare professional must report…

Article R1211-49 of the French Public Health Code

November 5, 2023

The following products of the human body are not subject to the provisions of this Title: 1° Hair ; 2° Nails ; 3° hair ; 4° Teeth.

Article R1211-50 of the French Public Health Code

November 5, 2023

Any doctor treating a patient of at least sixteen years of age shall ensure, at a time he or she deems appropriate, that the patient is aware of the possibility of organ donation for transplantation purposes, as well as the procedures for consenting to such donation, as provided for in Title I and Chapter II of Title III of Book II of Part One of this Code. The doctor will…

Article R1211-51 of the French Public Health Code

November 5, 2023

National education doctors and doctors in charge of preventive medicine in higher education establishments assist in informing pupils and students aged sixteen and over about organ donation for transplantation purposes and the procedures for consenting to this donation as provided for in Title I and Chapter II of Title III of Book II of Part One of this Code. They shall implement the information procedures provided for in the second…

Article D1221-1 of the French Public Health Code

November 5, 2023

The donation of blood or blood components may not give rise to any direct or indirect remuneration. In addition to any payment in cash, the following are particularly prohibited: any presentation of vouchers, discount coupons or other documents enabling an advantage to be obtained from a third party, as well as any gift of valuable objects, any service or any granting of advantages.

Article D1221-2 of the French Public Health Code

November 5, 2023

The remuneration paid by the employer to the donor in respect of his professional activity may be maintained during the time devoted to the donation without constituting payment within the meaning of article L. 1211-4, provided that the duration of the absence does not exceed the time required to travel between the place of work and the place of donation and, where applicable, to return, as well as for the…

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Regulatory part

Article R1211-35 of the French Public Health Code

Article R1211-36 of the French Public Health Code

Article R1211-37 of the French Public Health Code

Article R1211-38 of the French Public Health Code

Article R1211-39 of the French Public Health Code

Article R1211-49 of the French Public Health Code

Article R1211-50 of the French Public Health Code

Article R1211-51 of the French Public Health Code

Article D1221-1 of the French Public Health Code

Article D1221-2 of the French Public Health Code

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