In the cases referred to in Articles L. 5312-1 and L. 5312-2, and in the event of suspension or withdrawal of authorisation or registration of a product or group of products referred to in Article L. 5311-1, the Agency may order the natural or legal person responsible for placing the product on the market, putting it into service, making it available on the market or using it to withdraw the…
In the cases mentioned in articles L. 5312-1, L. 5312-2 and L. 5312-3, and in all cases where the interests of public health so require, the health authorities shall, if necessary, inform the general public and health professionals by any means and in particular by disseminating health messages or product recall notices using any appropriate medium. The Agence nationale de sécurité du médicament et des produits de santé shall set…
The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) imposes financial penalties on natural or legal persons producing or marketing products mentioned in Article L. 5311-1 or providing services associated with these products, which may be accompanied by daily fines, in the cases provided for by law and, where applicable, by decree of the Conseil d’Etat….
When, during an inspection, the Agence nationale de sécurité du médicament et des produits de santé finds that the laws and regulations applicable to the activities and products mentioned in Article L. 5311-1 have not been complied with, it may order the person concerned to rectify the situation within a period which it shall determine. This injunction is issued after the interested party has been given the opportunity to present…
The procedures for applying the provisions of this chapter shall be determined by decree in the Conseil d’Etat.
The Agency shall appoint inspectors from among its staff to monitor the application of laws and regulations, in particular the application of the rules of good practice defined by decision of the Agence nationale de sécurité du médicament et des produits de santé or by order of the Minister for Health pursuant to this code, as well as the common specifications or standards concerning the devices mentioned in Article 1…
The provisions of articles L. 1421-1 to L. 1421-3 and the first paragraph of article L. 5127-3 are applicable to the Agency’s inspectors. To carry out duties requiring pharmaceutical expertise, these inspectors must hold a diploma in pharmacy.
For the sole purpose of recording the offences provided for in articles L. 5421-2, L. 5421-3, L. 5421-13, L. 5432-1, L. 5432-2, L. 5438-4, L. 5461-3 and L. 5462-3 of the Public Health Code, when committed using electronic means of communication, the inspectors of the Agency mentioned in article L. 5412-1 authorised under conditions specified by order of the Ministers of Justice, the Interior and Health may, without being criminally…
In order to carry out its duties, the Agency may ask the ministers and regional health agencies concerned to call upon their agents authorised to monitor the application of legislative and regulatory provisions designed to protect human health. When they intervene at the Agency’s request, these agents shall act in accordance with the laws and regulations applicable to them and the good practices mentioned in Article L. 5313-1.
The procedures for applying the provisions of this chapter shall be determined by decree in the Conseil d’Etat.
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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