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Article L5232-3 of the French Public Health Code

Service providers and distributors of equipment, including medical devices or their accessories, designed to help people who are ill or have an incapacity or disability within the meaning of article L. 114 of the French Social Action and Family Code to return to their own homes and become independent, must have staff who hold a diploma, validated professional experience or equivalent attesting to training in the provision of this equipment…

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Article L5232-4 of the French Public Health Code

Healthcare professionals who use the healthcare products mentioned in 18° to 20° of Article L. 5311-1 shall report without delay to the Agence nationale de sécurité du médicament et des produits de santé any incident involving these products likely to have adverse effects on people’s health. The procedures for applying this article are determined by decree in the Conseil d’Etat.

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Article L5232-5 of the French Public Health Code

I.-Any person who places on the market products which, at the end of their manufacturing process, contain substances whose endocrine-disrupting properties the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (French National Agency for Food, Environmental and Occupational Health Safety) describes as known or suspected shall make available to the public electronically, in an open format that can be easily re-used and exploited by an automated…

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Article L5233-1 of the French Public Health Code

A national database on the location and accessibility of automated external defibrillators throughout France is created using information supplied by the operators of these devices to a body designated by decree to manage, operate and make this data available. An order by the Minister for Health sets out the information to be supplied by the operators and the procedures for its transmission.

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Article L5311-1 of the French Public Health Code

I.-The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) is a public establishment under the supervision of the Minister for Health. II-The Agency assesses the benefits and risks associated with the use of products intended for human health, products listed in Annex XVI of Regulation (EU) 2017/745 falling within its remit and products intended for cosmetic…

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Article L5311-2 of the French Public Health Code

In order to carry out its duties, the Agency : 1° Carry out or arrange for the carrying out of any expert appraisal or technical inspection relating to the products and articles mentioned in Article L. 5311-1, the substances of which they are composed and the methods and means of manufacture, packaging, preservation, transport and control applied to them; it carries out quality control of medical biology examinations and analyses…

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Article L5312-1 of the French Public Health Code

The Agence nationale de sécurité du médicament et des produits de santé may impose special conditions on, restrict or suspend the testing, manufacture, preparation, import, use, export, wholesale distribution, packaging, storage, placing on the market free of charge or against payment, holding with a view to sale or free distribution, advertising, putting into service, use, prescription, supply or administration of a product or group of products mentioned in Article L….

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Article L5312-1-1 of the French Public Health Code

Where it appears, on the occasion of a decision to suspend or prohibit an activity relating to a product or group of products taken by the National Agency for the Safety of Medicines and Health Products pursuant to Article L. 5312-1, that all or part of the activities of the natural or legal person concerned are being carried out under conditions presenting a proven risk to human health, the Agency…

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Article L5312-2 of the French Public Health Code

Without prejudice to any criminal proceedings that may be brought, where a product or group of products referred to in Article L. 5311-1 is placed on the market, put into service or used without having obtained the prior authorisation, registration or certification required by the legislative or regulatory provisions applicable to this product or group of products, the Agency may suspend, until the product or group of products has been…

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