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Article R5312-1 of the French Public Health Code

For the implementation of the monitoring and alert system mentioned in article L. 5312-4, the Agence nationale de sécurité du médicament et des produits de santé is responsible for receiving and processing reports of medicinal products suspected of being falsified and quality defects suspected of affecting medicinal products. This system also covers recalls of medicinal products by the companies or organisations that operate them, and withdrawals of medicinal products from…

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Article R5312-2 of the French Public Health Code

I – On the basis of inspections carried out in application of the provisions of Article L. 5313-1, the results of controls or evidence of breaches observed under Articles L. 5471-1 and R. 5471-1, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may initiate financial sanction proceedings against those responsible for these breaches. II – The Director General of the Agency will…

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Article R5312-3 of the French Public Health Code

The Minister for Health is the authorising officer responsible for issuing collection orders relating to penalties and periodic penalty payments ordered pursuant to articles L. 5312-4-1, L. 5471-1 and R. 5471-1. The collection order is issued and made enforceable under the conditions laid down in articles 112 to 124 of decree no. 2012-1246 of 7 November 2012 on public budgetary and accounting management.

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