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Showing 10581–10590 of 36632 articles for “Art. al. 5”
A schedule of periods for submitting the visa applications referred to in Article L. 5122-8 is set for each year, by decision of the Director General of the National Agency for the Safety of Medicines…
For the application of the provisions of this chapter, army hospitals and the army blood transfusion centre shall be regarded as health establishments and a blood transfusion establishment respectivel…
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…
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…
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…
The pharmacovigilance correspondent for blood-derived medicinal products mentioned in article R. 5121-181 is responsible within the establishment for dispensing and monitoring these medicinal products…
…em, any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 : 1° Implements a risk management system for each medicinal product or each product for whi…
…alth Products carries out its pharmacovigilance 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 prev…
…mply with the information given in the summary of product characteristics referred to in article R. 5121-21 and with the therapeutic strategies recommended by the Haute Autorité de santé referred to i…
The application for authorisation is deemed to be complete if, within one month of receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not info…
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