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Showing 2201–2210 of 56508 articles for “Art. Cass. com. 13-1-2009 n° 07-20.097”
The Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Records any adverse reaction suspected to be due to a medicinal product or to a product mentioned in…
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…
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…
The healthcare establishment has a paediatric continuous monitoring unit; this may specialise in organ transplants in accordance with the provisions of article R. 6123-38-7. The intensive care activit…
The staff referred to in Article D. 6124-163 includes at least one paediatrician who can intervene within a timeframe compatible with safety requirements. The medical and nursing staff are experienced…
The child is hospitalised in a dedicated sector of a paediatric unit or, where justified by the patient's age or characteristics, in an individualised area of a hospital sector with a paediatric envir…
Failure to comply with Article 5(d)(3) and (8) and Articles 8 and 9 of Regulation (EU) No 260/2012 of the European Parliament and of the Council of 14 March 2012 establishing technical and commercial…
The number of medical and paramedical staff is adapted to the haematopoietic cell transplant activity and the follow-up of transplant patients. It includes : 1° At least two doctors, each with a quali…
The transplanted child is hospitalised in a dedicated sector of a paediatric unit or in an individualised area with a paediatric environment within the hospitalisation sector mentioned in article R. 6…
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