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Showing 1461–1470 of 5626 articles for “Art. n° 15-18.970 F-PB”
I.-The Agence nationale de sécurité du médicament et des produits de santé shall fulfil its obligations in terms of pharmacovigilance and participation in European Union activities in this field.The N…
I.-The Director General of the Agency may ask the regional pharmacovigilance centres to carry out any pharmacovigilance investigations and work.He may also ask the drug dependence and addictovigilance…
The regional pharmacovigilance centres carry out vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, in…
For the purposes of this chapter, the following definitions shall apply 1° "Adverse reaction": a noxious and unintended response to a medicinal product or to a product mentioned in Article R. 5121-150…
Pharmacovigilance includes: 1° The reporting of adverse reactions suspected to be due to a medicinal product or a product mentioned in article R. 5121-150, including cases of overdose, misuse, abuse a…
Withdrawal of the approval provided for in the third paragraph of Article L. 5122-9 is decided by the Director General of the Agence nationale de sécurité du médicament et des produits de santé after…
The suspension, which may not exceed one year, and the withdrawal of the authorisation to open, provided for in article L. 5124-3, are decided by the Director General of the Agence nationale de sécuri…
A société d'exercice libéral de pharmaciens d'officine is formed subject to the condition precedent that it is entered on the roll of the ordre under the conditions set out in articles R. 4222-1 et se…
The premises are installed and equipped in such a way as to ensure the proper storage, monitoring and, if necessary, withdrawal of the medicinal products, products or articles mentioned in Articles L.…
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