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Showing 3231–3240 of 23443 articles for “Art. Cass. 1re civ. 13 April 1999 · Cass. 1re civ. 13 July 2004 · Cass. 3e civ. 24 June 1971”
…the Pharmacovigilance Risk Assessment Committee referred to in Article 56 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004. The draft protocol is submitted…
This sub-section applies to post-authorisation safety studies of a non-interventional nature within the meaning of Article R. 1121-2, which give rise to the collection of safety information from patie…
The doctor, dental surgeon, midwife, pharmacist or nurse shall immediately report any adverse reaction suspected of being due to a medicinal product or to a product mentioned in article R. 5121-150 of…
…body mentioned in Article L. 4211-9-1 or the pharmaceutical establishment mentioned in Article L. 5124-1 or Article L. 5124-9-1 ; 3° The patient's surname, first name and date of birth; 4° The product…
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…
…ues and cells mentioned in Article R. 1211-19 and in the good practices provided for in Article L. 1245-6, or those relating to blood and its components as provided for in Articles R. 1221-36 et seq,…
Blood establishments and organisations or companies manufacturing or exploiting blood-derived medicinal products which are aware of information likely to cast doubt on the quality of blood or plasma i…
…referred to in Article L. 4211-9-1 or any pharmaceutical establishment referred to in Articles L. 5124-1 or L. 5124-9-1 shall set up and keep up to date a system ensuring the traceability of advanced…
…f interruption or cessation of activity of a pharmaceutical establishment mentioned in article L. 5124-1 or article L. 5124-9-1 manufacturing advanced therapy medicinal products prepared on an ad hoc…
The data referred to in II and III of Article R. 5121-201-5 and a copy of the administration record referred to in Article R. 5121-201-6 shall be kept by the establishments referred to in Article R. 5…
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