Article R5121-158
The regional pharmacovigilance centres carry out vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
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Showing 1421–1430 of 10570 articles for “Art. Avis CEPC n° 15-03”
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…
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.…
The Director referred to in article R. 5312-26 may impose the penalty provided for in this article for deliberate acts, in accordance with the procedures set out in article L. 5426-9 et seq. When cons…
If the employment contract is terminated before the end of the training period referred to in article R. 5522-12, the sums already paid to the employer corresponding to training hours not completed wi…
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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