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Showing 2631–2640 of 5976 articles for “Art. 131-13”
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…
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…
The formalities of transcribing, recording and drawing up the forms provided for in this paragraph take the place of the transcriptions and recordings mentioned in article R. 5132-10.
When a healthcare professional administers a blood-derived medicinal product outside healthcare establishments or the establishments and organisations mentioned in article R. 5121-192, he/she affixes…
In blood transfusion establishments and in any organisation other than pharmacies, health establishments and health cooperation groups authorised to dispense blood-derived medicinal products, these me…
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