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Article R5124-34 of the French Public Health Code

The responsible pharmacist is : 1° In the companies referred to in article L. 5124-2 : a) In public limited companies other than those governed by articles L. 225-57 et seq. of the Commercial Code, the Chairman of the Board of Directors who is the Chief Executive Officer, the Chief Executive Officer or a Deputy Chief Executive Officer; b) In sociétés anonymes governed by these articles, either the Chairman of…

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Article R5124-35 of the French Public Health Code

Within one month of its implementation, the company or organisation informs the Director General of the Agence nationale de sécurité du médicament et des produits de santé, via a dedicated internet portal, of the appointment of a new responsible pharmacist as defined in Article L. 5124-2. The company or organisation shall send the competent central council of the national order of pharmacists, unless the person concerned is a pharmacist covered…

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Article R5124-36 of the French Public Health Code

With a view to applying the rules laid down in the interests of public health, the pharmacist in charge defined in article R. 5124-34 assumes the following duties insofar as they correspond to the activities of the company or organisation in which he works: 1° He organises and supervises all the pharmaceutical operations of the company or organisation, and in particular the manufacture, advertising, information, pharmacovigilance, batch monitoring and withdrawal,…

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Article R5124-37 of the French Public Health Code

If the duties of a pharmacist in charge are terminated or not renewed, the person concerned may refer the matter to the central council of the relevant section of the Ordre national des pharmaciens. After hearing both parties, the Council will issue an opinion as to whether or not the person concerned has failed to fulfil the obligations incumbent upon him, in the interests of public health, in his capacity…

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