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Showing 7481–7490 of 29656 articles for “Art. Cass. com. 13-6-1995”
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…
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…
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…
The regional pharmacovigilance centres carry 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…
The doctor, dental surgeon, midwife, pharmacist or nurse shall immediately report any adverse reaction suspected of being due to a medicinal product or to a product mentioned in article R. 5121-150 of…
The regional pharmacovigilance centres inform the Agence nationale de sécurité du médicament et des produits de santé on the same day of the reports of adverse reactions likely to be due to a blood-de…
Blood establishments and organisations or companies manufacturing or exploiting blood-derived medicinal products which are aware of information likely to cast doubt on the quality of blood or plasma i…
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