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Article R5322-11 of the French Public Health Code

The Board of Directors sets the guidelines for the agency’s policy through its deliberations. It adopts its own rules of procedure. It deliberates on the following matters 1° The general organisation of the agency and its consultative committees; 2° Multiannual strategic guidelines; 3° The performance contract signed with the State; 4° The annual work programme; 5° The activity report; 6° The agency’s internal regulations; 7° The budget and its amending…

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Article R5322-12 of the French Public Health Code

With regard to the matters mentioned in 12° and 13° of Article R. 5322-11, the Board of Directors may delegate to the Chief Executive Officer all or part of its powers within limits that it shall determine. The Chief Executive Officer shall report to the next meeting of the Board of Directors on the decisions he has taken by virtue of this delegation.

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Article R5322-13 of the French Public Health Code

The decisions of the Board of Directors concerning the budget and the financial account are enforceable under the conditions laid down in Title III of Decree no. 2012-1246 of 7 November 2012 on public budgetary and accounting management. Decisions relating to the matters mentioned in 2°, 9° and 10° of Article R. 5322-11 are approved under the same conditions. Decisions relating to 14° of article R. 5322-11 are enforceable one…

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Article R5322-14 of the French Public Health Code

The Director General of the Agence nationale de sécurité du médicament et des produits de santé is appointed for a period of three years, renewable once. He manages the establishment. He performs all acts that are not reserved to the Board of Directors by virtue of article R. 5322-11. He prepares the decisions of the Board of Directors and ensures that they are implemented. He represents the agency in legal…

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Article R5322-15 of the French Public Health Code

The Chief Executive is the authorising officer for the revenue and expenditure of the Agency’s budget. He may appoint secondary authorising officers. He may delegate his signature to staff under his authority. These delegations are published on the website of the Agence nationale de sécurité du médicament et des produits de santé.

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Article R5322-16 of the French Public Health Code

The list of decisions of the Director General referred to in Article L. 5322-2 which are communicated to the Ministers for the Economy, Health and Social Security for information fifteen days before their notification is set by order of the same Ministers. This time limit does not apply in the event of a serious threat to public health.

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Article R5322-17 of the French Public Health Code

The Scientific Advisory Board is responsible for : 1° To ensure the consistency of the Agency’s scientific strategy, taking into account recent developments both in methodology and in knowledge of the efficacy and safety of health products, in the national, European and international context; 2° Giving an opinion on research guidelines and on the Agency’s partnership and scientific programming policy; 3° Assisting the Director General of the Agency in drawing…

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Article R5322-18 of the French Public Health Code

The Board comprises : 1° Ten members, appointed for a renewable period of three years by order of the Minister for Health on the basis of their scientific expertise in the field of health products, on the proposal of the Chief Executive Officer and following a call for candidates made by the Agency; 2° Six leading scientists, including foreign scientists, appointed for a renewable period of three years by order…

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