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Showing 2661–2670 of 5976 articles for “Art. 131-13”
A joint order of the ministers responsible for labour, radiation protection and agriculture shall determine: 1° With regard to the competent person in charge of radiation protection: a) The content an…
To be designated as a radiation protection advisor, the following is required: 1° For the person competent in radiation protection, a training certificate issued by a training body certified by a cert…
When, in the light of the results of individual dosimetric monitoring, the exposure of a worker has exceeded one of the dose limit values set in Article R. 4451-6, the Institut de Radioprotection et d…
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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