Article R5132-101
The Director General of the Agence nationale de sécurité du médicament et des produits de santé provides all relevant information to the European Medicines Agency, as well as to the International Narc…
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Showing 2731–2740 of 60498 articles for “Art. Decree 2022-1294 of 5-10-2022”
The Director General of the Agence nationale de sécurité du médicament et des produits de santé provides all relevant information to the European Medicines Agency, as well as to the International Narc…
Any doctor, dental surgeon or midwife who becomes aware of a serious case of pharmacodependence, abuse or misuse of a substance, plant, medicinal product or other product mentioned in article R. 5132-…
The drug dependence and addictovigilance assessment and information centres carry out their vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
…whom has been reported, a serious or unexpected adverse reaction which may be attributed to the use of a veterinary medicinal product, whether or not he has prescribed it, or a medicinal product for h…
A company operating a veterinary medicinal product must: 1° Keep detailed records of all suspected adverse reactions which have occurred inside or outside the European Union; 2° To record any suspecte…
…inary medicinal products authorised by the European Medicines Agency in Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for…
…igilance update report mentioned in articles R. 5141-103 to R. 5141-105-1 are laid down by decision of the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'enviro…
The creation, organisation and funding of veterinary pharmacovigilance centres, as well as the conditions under which they carry out the tasks entrusted to them by the Agence nationale de sécurité san…
Where the initial authorisation was granted after the Director General of the Agence nationale de sécurité du médicament et des produits de santé or the Prefect had been informed in accordance with th…
Under the conditions laid down in article L. 5143-7, the regional prefect of the group's registered office approves the animal health programmes and grants approval to the groups mentioned in article…
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