Article R5121-156
…o a medicinal product or to a product mentioned in Article R. 5121-150, occurring in France, which has been reported or notified to it; 2° Report electronically to the European database "Eudravigilanc…
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Showing 2591–2600 of 23743 articles for “Art. Cass. 13 March 2008 – counterfeit as dispossession”
…o a medicinal product or to a product mentioned in Article R. 5121-150, occurring in France, which has been reported or notified to it; 2° Report electronically to the European database "Eudravigilanc…
…lance missions under the conditions defined in Article R. 5311-2 in order to carry out a scientific assessment of all information, to examine options for preventing or reducing risks and, if necessary…
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…
…This supply is managed in accordance with the provisions of the order provided for in article R. 5132-42. When a medicinal product is taken from the supply provided for in the previous paragraph, th…
…irector 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, initiates…
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…
When the in-house pharmacy dispenses a blood-derived medicinal product directly to a patient, the information referred to in article R. 5121-187 is transcribed onto a special register marked and initi…
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