Article R5121-178-1
…ticle applies to the post-authorisation safety studies referred to in Article R. 5121-178 which are carried out either voluntarily by the holder of the marketing authorisation referred to in Article L…
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Showing 2251–2260 of 6711 articles for “Art. CA Rouen 13 juin 2000 n° 1999/04931”
…ticle applies to the post-authorisation safety studies referred to in Article R. 5121-178 which are carried out either voluntarily by the holder of the marketing authorisation referred to in Article L…
The regional pharmacovigilance centres carry out vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
…This article applies to the post-authorisation studies referred to in article R. 5121-178 which are carried out by the holder of the authorisation referred to in article L. 5121-8 in order to comply w…
…f Article R. 1121-2, which give rise to the collection of safety information from patients or healthcare professionals. These studies are carried out under the responsibility of the marketing authoris…
…reorganisation and liquidation of credit institutions and investment firms set out in articles L. 613-25 to L. 613-30 and L. 211-10 do not apply to legal proceedings opened before 29 June 1999.
…ed in article R. 5121-150 of which he is aware to the regional pharmacovigilance centre.Other healthcare professionals, patients and approved patient associations may report any adverse reaction suspe…
…hand column of the following table shall apply in the Wallis and Futuna Islands, in the wording indicated in the right-hand column of the same table: Articles applicable In the wording resulting from…
…he name and address of the establishment or 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,…
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…
The pharmacovigilance carried out on individually prepared advanced therapy medicinal products includes monitoring to ensure traceability between the various stages, from the removal of tissues, cells…
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