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Showing 2341–2350 of 7188 articles for “Art. CJEU C-623/13”
In health establishments and health cooperation groups with an in-house pharmacy, the pharmacist managing this pharmacy is the correspondent of the regional pharmacovigilance centre for blood-derived…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Records any adverse reaction suspected to be due to a medicinal product or to a product mentioned in…
I.-The Agence nationale de sécurité du médicament et des produits de santé shall fulfil its obligations in terms of pharmacovigilance and participation in European Union activities in this field.The N…
Without prejudice to the obligations laid down in Articles R. 5121-138 to R. 5121-142, the packaging of a blood-derived medicinal product includes three detachable labels, separate from the informatio…
In the establishments referred to in Article R. 5121-187, the person administering the blood-derived medicinal product to the patient completes the dispensing and administration slip with the followin…
I.-The Director General of the Agency may ask the regional pharmacovigilance centres to carry out any pharmacovigilance investigations and work.He may also ask the drug dependence and addictovigilance…
Exceptionally, after consultation with the managing pharmacist, by decision of the director of the health establishment or the administrator of the Groupement de Coopération Sanitaire, departments may…
I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, in…
In health establishments and health cooperation groups authorised under article L. 6133-7 to carry out the tasks of these establishments which do not have an in-house pharmacy which hold blood-derived…
The registers or records provided for in articles R. 5121-185 to R. 5121-193 are kept for a period of forty years. Where necessary for the purposes of pharmacovigilance, the regional pharmacovigilance…
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