Article R5121-198
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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Showing 1191–1200 of 37717 articles for “Art. L 623-19”
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…
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…
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…
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…
The correspondent mentioned in article R. 5121-181 who receives the report provided for in article R. 5121-196 immediately forwards it to the regional pharmacovigilance centre. If he is otherwise awar…
Organisations or companies exploiting blood-derived medicinal products which have knowledge of adverse reactions likely to be due to these medicinal products inform the Director General of the Agence…
When a person authorised to prescribe, dispense or administer medicinal products becomes aware of an adverse reaction which may be due to a blood-derived medicinal product, he/she shall report it imme…
All pharmaceutical acts are carried out under the effective control of a pharmacist who meets the conditions for practising pharmacy in France.
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