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Article R5321-5 of the French Public Health Code

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…

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Article D5321-7 of the French Public Health Code

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…

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Article D5321-8 of the French Public Health Code

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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Article R5322-1 of the French Public Health Code

In addition to its Chairman, the Agency’s Board of Directors comprises: 1° Nine members representing the State: a) Three representatives of the Ministers for Health and Social Action; b) One representative of the Minister for Social Security; c) One representative of the Minister for the Budget; d) One representative of the Minister for Research; e) Two representatives of the Minister for the Economy and Finance; f) One representative of the…

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Article R5322-2 of the French Public Health Code

The term of office of the members of the Board of Directors is three years, with the exception of the term of office of the members mentioned in 2° of article R. 5322-1. For the latter, the term of office of deputies ends with the legislature for which they were elected and the term of office of senators ends with each partial renewal of the Senate. The term of office…

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Article R5322-3 of the French Public Health Code

The Chairman of the Board of Directors is appointed for a term of three years, renewable once. The age limit for the Chairman is sixty-seven. The duties of Chairman of the Board of Directors are incompatible with those of Chief Executive Officer of the Agency. The Board of Directors elects from among its members a Vice-Chairman chosen from among the members mentioned in 3°, 5° or 6° of article R….

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