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Showing 2281–2290 of 5201 articles for “Art. no. 13-14374”
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…
Where the conceding authority decides not to award the concession contract or to recommence the procedure, it shall inform the candidates or tenderers of the reasons for its decision as soon as possib…
A decision by the Director General of the Agence nationale de sécurité du médicament et des produits de santé defines the principles of good pharmacovigilance practice. This decision also sets out the…
The court which has ordered the opening of the collective coordination proceedings shall decide on the coordinator's request submitted in accordance with paragraph 6 of Article 72 of the Regulation an…
A judgment dismissing the coordinator pursuant to Article 75 of the aforementioned Regulation (EU) 2015/848 may not be appealed.
Under Article 71(1) of Regulation (EU) No 2015/848, persons entered on the list of judicial administrators or judicial representatives pursuant to Articles L. 811-2 and L. 812-2 or an insolvency pract…
The official receiver shall authorise the court-appointed agent to accept or refuse inclusion in a coordination procedure of the insolvency proceedings in which he is appointed, as well as to apply to…
The official receiver shall rule by a non-appealable order on disagreements relating to the collective coordination procedure between the judicial administrator and the judicial representative appoint…
A decree in Council of State shall specify the conditions of application of this chapter.
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