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Showing 2211–2220 of 5744 articles for “Art. n° 13-12.592”
Interventional cardiology imaging is carried out in three ways: 1° Interventional arrhythmology; 2° Congenital heart disease excluding arrhythmology; 3° Ischaemic and structural heart disease in adult…
Legal tests and economic and accounting subjectsCivil law: General concepts on:-property: classification of property, movables, methods of acquiring ownership, possession, usufruct;-obligations: sourc…
Pharmacovigilance is carried out :1° For medicinal products and for products which must be covered by the marketing authorisation provided for in article L. 5121-8, after this authorisation has been i…
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…
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