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Showing 2201–2210 of 5384 articles for “Art. 13 juill. 2005”
…ucts in article R. 5121-172 ;3° For the homeopathic medicinal products mentioned in article L. 5121-13, after the registration provided for in that article;4° For the traditional herbal medicinal prod…
…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…
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…
…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…
…pecuniary penalties are recovered in accordance with the procedures determined by the decree no. 64-1333 of 22 December 1964 relating to the recovery of fines and pecuniary penalties by the accountant…
The provisions of articles 707-2 and 707-4 relating to the reduction in the amount of fines in the event of voluntary payment within one month are applicable to foreign pecuniary penalties when they a…
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