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Showing 6101–6110 of 26420 articles for “Art. Cass. 3e civ. 19-11-2014 n° 13-20.089”
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…
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…
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…
Pharmacovigilance of blood-derived medicinal products involves monitoring, known as traceability, from the time they are manufactured until they are administered to patients. The purpose of this monit…
In healthcare establishments and other establishments with an in-house pharmacy, blood-derived medicinal products are dispensed by the in-house pharmacy on the basis of a medical prescription.The in-h…
Dispensing pharmacists who dispense a blood-derived medicinal product must immediately transcribe the information mentioned in article R. 5132-10, the patient's date of birth and the information appea…
A pharmaceutical establishment manufacturing, operating, importing, exporting or wholesaling blood-derived medicinal products must, when disposing of these medicinal products, record :1° The name, str…
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