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Showing 2201–2210 of 21578 articles for “Art. Cass. com. 13 December 2023”
…ct mentioned in Article R. 5121-150 concerning one or more of these medicinal products or products; 13° "Medication error": an unintentional error by a healthcare professional, a patient or a third pa…
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 they are unable to respond to a request for information or where they refuse to respond to such a request for one of the reasons provided for in articles 695-9-39 to 695-9-42, the departments an…
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…
For the application of Council Framework Decision 2006/960/JHA of 18 December 2006, the services or units of the national police, the national gendarmerie, the Directorate-General for Customs and Exci…
Without prejudice to the provisions of Article 11 relating to the confidentiality of investigations, any information or data exchanged shall be confidential. The procedures for transmitting and storin…
This article applies to the post-authorisation safety studies referred to in Article R. 5121-178 which are carried out either voluntarily by the holder of the marketing authorisation referred to in Ar…
…rry out vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
I.-This article applies to the post-authorisation studies referred to in article R. 5121-178 which are carried out by the holder of the authorisation referred to in article L. 5121-8 in order to compl…
This sub-section applies to post-authorisation safety studies of a non-interventional nature within the meaning of Article R. 1121-2, which give rise to the collection of safety information from patie…
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