French Business Law - French Legislation

Article R1222-28 of the French Public Health Code

November 5, 2023

I. – The role of risk and quality management manager involves setting up, evaluating and updating the risk and quality management system of the blood establishment. II. – This position is held by a doctor, a pharmacist or a person who holds an engineering degree or a national graduate or post-graduate degree in life sciences, chemistry, physics or quality, and who also meets the conditions of training and professional experience…

Article R1222-29 of the French Public Health Code

November 5, 2023

I. – The role of the person responsible for quality control in the blood establishment involves checking that labile blood products, medical devices and equipment comply with pre-established standards or specifications. II. – This position is held by a doctor, a pharmacist or a person who holds an engineering degree or a national graduate or postgraduate diploma in the life sciences, chemistry or physics, and who can also demonstrate the…

Article R1222-30 of the French Public Health Code

November 5, 2023

Analyses within the donation’s biological qualification laboratory may only be carried out by the persons authorised to be employed as medical laboratory technicians mentioned in articles L. 4352-2 to L. 4352-3-2 under the responsibility of the person mentioned in the first paragraph of article R. 1222-31.

Article R1222-31 of the French Public Health Code

November 5, 2023

I.-The head of the laboratory for the biological qualification of donations shall ensure compliance with the regulations applicable to analyses relating to the biological qualification of donations and the proper transmission of information and results between his laboratory and those responsible for the activities of blood establishments whose donations the laboratory qualifies. He/she is responsible for the quality of the analyses carried out. It is responsible for the general organisation…

Article R1222-32 of the French Public Health Code

November 5, 2023

Blood transfusion establishments offer training in good practice and new techniques relating to their activity to staff who carry out the duties defined by this section, in accordance with the procedures and frequency laid down by order of the Minister for Health.

Article R1222-33 of the French Public Health Code

November 5, 2023

The provisions of this section apply to the Armed Forces Blood Transfusion Centre.

Article R1222-34 of the French Public Health Code

November 5, 2023

The activities of the Etablissement Français du Sang are carried out in accordance with : 1° The approval referred to in III of Article L. 1222-11 issued by the Agence nationale du médicament et des produits de santé to the Etablissement français du sang or its blood establishments, depending on the geographical area in which the transfusion activities are carried out; 2° The rules applicable to these activities; 3° The…

Article R1222-35 of the French Public Health Code

November 5, 2023

The collection of blood and its components, their biological qualification, the preparation, processing, distribution and issue of labile blood products are carried out in compliance with the good practices defined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, taken in application of article L. 1222-12. For each of these activities and on each of the sites where they are…

Article R1222-36 of the French Public Health Code

November 5, 2023

All blood establishments have the means to ensure the quality control of their products. However, the blood establishment may entrust quality control, under an agreement, either to another blood establishment or to an external laboratory authorised to carry out the corresponding activity; it may also enter into an agreement for the irradiation of the products it prepares with another blood establishment or, where appropriate, with a health establishment.

Article R1222-37 of the French Public Health Code

November 5, 2023

Each team carrying out whole blood sampling at a fixed or mobile site includes, in addition to the presence of a person mentioned in II of Article R. 1222-17: a) A person authorised to carry out the sampling and meeting the conditions laid down in Article R. 1222-18; b) A nurse if the team consists of more than three people; In the absence of a doctor, a means of communication…

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Book II: Donation and use of human body parts and products

Article R1222-28 of the French Public Health Code

Article R1222-29 of the French Public Health Code

Article R1222-30 of the French Public Health Code

Article R1222-31 of the French Public Health Code

Article R1222-32 of the French Public Health Code

Article R1222-33 of the French Public Health Code

Article R1222-34 of the French Public Health Code

Article R1222-35 of the French Public Health Code

Article R1222-36 of the French Public Health Code

Article R1222-37 of the French Public Health Code

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Book II: Donation and use of human body parts and products

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Contact a French Business Lawyer

Do you need French-law advice? Contact our Lawyers in France.

Our attorneys will contact you promptly within 24h. All information exchanged through this website will be communicated to attorneys only, and will remain confidential.

We Solve Legal & Tax Issues in France

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