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Showing 141–150 of 529 articles for “Art. 150 U”
Patient management procedures are defined in a protocol agreed between the medical heads of interventional neuroradiology and those of the units concerned. This protocol specifies, in particular, the…
I.-The holder ensures that the medical and paramedical team identifies and regularly updates the recommendations for good practice to be applied, and implements an assessment of compliance with these…
Agreements organising the emergency management of patients are concluded between the holders of the authorisation performing the interventional activity and the establishments authorised to practice e…
As part of the pharmacovigilance system, any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 : 1° Implements a risk management system for each medi…
For the medicinal products mentioned in 1° of II of article L. 5121-12 and in II of article L. 5121-12-1, the obligations set out in article R. 5121-161 and articles R. 5121-166 to R. 5121-170 are car…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 shall implement a pharmacovigilance system in order to fulfil its pharmacovigilance obligations…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 is required to: 1° Record all adverse reactions suspected of being due to a medicinal product o…
Any company or organisation exploiting a medicinal product or a product referred to in Article R. 5121-150 has at its disposal on a permanent basis the services of a person responsible for pharmacovig…
The holder of the authorisation provided for in Article L. 4211-6 is required to report the following to the Director General of the Agence nationale de sécurité du médicament et des produits de santé…
The company or organisation exploiting a medicinal product or a product referred to in Article R. 5121-150 may not communicate information relating to pharmacovigilance to the general public about thi…
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