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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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Article R5323-1 of the French Public Health Code

The decision concerning the general conditions of employment and recruitment of personnel mentioned in 14° of article R. 5322-11 sets the compensation for on-call duty. This decision also determines, for each job category, the corresponding pay scales and the length of time spent in each step.

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Article R5323-2 of the French Public Health Code

The provisions of article R. 4113-110 are applicable to the members of the boards, commissions, committees and working groups that sit with the Agency, as well as to the persons who occasionally collaborate in their work, including when they do not belong to the health professions.

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Article R5411-1 of the French Public Health Code

Public health inspecting pharmacists and inspectors from regional health agencies who are pharmacists are authorised and sworn to investigate and record the offences referred to in article L. 5411-1 under the conditions set out in articles R. 1312-2 and R. 1312-4 to R. 1312-7.

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Article R5412-1 of the French Public Health Code

For the application of Article L. 5412-1, the inspectors referred to in Article R. 5313-1 are authorised to investigate and establish criminal offences by a decision of the Director General of the Agency, specifying the name, capacity and qualifications of the agents concerned. The authorisation lasts for two years. It may be renewed. Authorised agents take the following oath before the judicial court in whose jurisdiction the head office of…

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Article R5413-1 of the French Public Health Code

Medical public health inspectors and inspectors from regional health agencies who are doctors are authorised and sworn to investigate and record the offences mentioned in article L. 5413-1 under the conditions set out in articles R. 1312-2 and R. 1312-4 to R. 1312-7.

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