Article R5121-152
…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…
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Showing 3541–3550 of 9503 articles for “Art. CJEU – C-593/21 – 13 Oct. 2022”
…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…
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…
Before administering the punctually prepared advanced therapy medicinal product, the health professional in the health establishment must ensure that the information required for the traceability of t…
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…
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