Article R5321-1 of the French Public Health Code
November 1, 2023
The Agency is subject to the provisions of Titles I and III of Decree 2012-1246 of 7 November 2012 on public budgetary and accounting management.
The Agency is subject to the provisions of Titles I and III of Decree 2012-1246 of 7 November 2012 on public budgetary and accounting management.
The annual amount of the grant from the compulsory health insurance schemes mentioned in 5° of article L. 5321-2 is set by order of the ministers responsible for health, social security and the budget.
Secondary accounting officers may be appointed by order of the ministers responsible for the budget and health, on the proposal of the agency’s general manager and after consulting the accounting officer.
Revenue and imprest accounts may be set up under the conditions set out in Decree no. 2019-798 of 26 July 2019 on the revenue and imprest accounts of public bodies.
Members of commissions, committees, working groups and other expert collegiate bodies, as well as external experts used by the Agency and appearing on a list drawn up by the Agency’s Director General, may receive compensation for work, reports and studies carried out for the Agency under conditions set by the Board of Directors. When their attendance at meetings results in a loss of income, salaried members and self-employed members sitting…
Meetings of the commissions, committees and bodies of the Agency referred to in Article L. 5324-1 are open to the public under the conditions defined in Articles L. 1451-1-1 and R. 1451-6 to R. 1451-9.
The amount of the duty provided for in Article L. 5321-3 is set as follows: 1° Under 1° of I : For the analysis of samples and the assessment 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 : €3,500. For the assessment of the documentation relating to…
I.-The examination by the Agence nationale de sécurité du médicament et des produits de santé of the application for a certificate of good manufacturing practice provided for in Article R. 5131-2 of the Public Health Code gives rise to the prior payment of a fee. II – The amount of the fee provided for in I is set at 1,400 euros per certificate application. III -The Agence nationale de sécurité…
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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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