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Article L5146-4-1 of the French Public Health Code

November 6, 2023

The agents mentioned in 2°, 3° and 4° of the I of article L. 5146-1 may order the immediate denaturing or destruction, by any approved disposal channel, of the following products: 1° Veterinary medicinal products that have expired or do not have an expiry date placed in usable stock; 2° Veterinary medicinal products recognised as unfit for use or likely to present a danger to public health; 3° Veterinary medicinal…

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Article L5146-4-2 of the French Public Health Code

November 6, 2023

The officers mentioned in 2°, 3° and 4° of article L. 5146-2 may summon or interview any person who may be able to provide information relevant to their findings. They shall draw up a report, which must include the questions to be answered. The persons interviewed read the minutes themselves, may have their observations recorded and sign them. If they state that they are unable to read it, the officer…

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Article L5150-1 of the French Public Health Code

November 6, 2023

Articles L. 125-3, L. 531-1 to L. 531-3-2, L. 533-1 to L. 533-8, L. 535-1 to L. 535-9, L. 536-1 to L. 536-5, L. 536-8 and L. 537-1 of the Environment Code apply to the products mentioned in Article L. 5311-1 and to the veterinary medicinal products mentioned in Article L. 5141-2 of this Code.

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Article L5211-1 of the French Public Health Code

November 6, 2023

I.-The placing on the market, putting into service and making available on the market of medical devices and their accessories shall comply with the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and with the provisions of this Title. These provisions shall also apply to the groups of products not intended for medical use listed in Annex XVI to the same…

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Article L5211-2 of the French Public Health Code

November 6, 2023

I.-Without prejudice to the provisions of II, the Agence nationale de sécurité du médicament et des produits de santé has the status of competent authority for the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, under the conditions specified by the provisions of this Part. In this capacity, the agency shall in particular: 1° The tasks provided for at the stage…

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Article L5211-3 of the French Public Health Code

November 6, 2023

I.-The devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 shall be placed on the market or put into service in accordance with Article 5 of that Regulation and this Article. II.-Pursuant to Article 59 of this Regulation, the Agence nationale de sécurité du médicament et des produits de santé may, upon duly justified request, by way…

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Article L5211-3-1 of the French Public Health Code

November 6, 2023

The economic operators referred to in paragraph 35 of Article 2 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are required to register under the conditions laid down in Article 31 of the same Regulation. In addition, the following are required to declare their activities to the Agence nationale de sécurité du médicament et des produits de santé, under conditions specified by…

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is a Registered Trademark of
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75001, Paris France
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is a Registered Trademark of
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75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396

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