Article L5312-5 of the French Public Health Code
November 6, 2023
The procedures for applying the provisions of this chapter shall be determined by decree in the Conseil d’Etat.
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.
The Agency is subject to an administrative, budgetary, financial and accounting system and to State control adapted to the specific nature of its mission, as defined in this Book and specified by decree in the Conseil d’Etat.
The agency’s resources are made up of : 1° A subsidy from the State ; 2° Subsidies from other public authorities, their public establishments, social security bodies, the European Union or international organisations; 3° From miscellaneous income, donations and legacies; 4° By loans; 5° A grant from the compulsory health insurance schemes, paid and distributed in accordance with conditions laid down by decree. The Agency may not receive donations from…
I.-A fee is payable by the applicant for the performance by the Agency of the following operations: 1° Analysis of samples and evaluation of the documentation relating to the control protocol submitted by the manufacturer with a view to the release of batches of immunological medicinal products mentioned in 6° of Article L. 5121-1, blood-derived medicinal products mentioned in Article L. 5121-3 and substances which, if used separately from a…
A decree in the Conseil d’Etat shall determine the conditions under which one or more of the Agency’s support and back-up services may be pooled with one or more services of other bodies pursuant to Article L. 1411-5-3.
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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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