Article R5121-156
The Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Records any adverse reaction suspected to be due to a medicinal product or to a product mentioned in…
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Showing 1521–1530 of 57478 articles for “Art. CE 15 Apr 2016 n° 390457 and 390774”
The Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Records any adverse reaction suspected to be due to a medicinal product or to a product mentioned in…
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…
…he 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 ; 2°…
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…
…vided 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 beneficiary of the approva…
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 central and external services of the Délégation générale à l'emploi et à la formation professionnelle are authorised to check with the bodies listed in article D. 5427-4 that the legal provisions…
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