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Showing 1411–1420 of 56058 articles for “Art. Decree of 16 August 1901”
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…
…ental 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 which he is…
…mentioned in Article R. 5121-150 manages a permanent pharmacovigilance system file and makes a copy of this file available within seven days, at the request of the Director General of the Agence natio…
…product mentioned in Article R. 5121-150 is required to: 1° Record all adverse reactions suspected of being due to a medicinal product or a product mentioned in Article R. 5121-150, occurring in a Me…
…a product referred to in Article R. 5121-150 has at its disposal on a permanent basis the services of a person responsible for pharmacovigilance residing and practising in a Member State of the Europ…
…product without sending it, beforehand or, in an emergency, simultaneously, to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, to the European Medicine…
…to the benefits and risks associated with this medicinal product or product, including the results of studies which may have an impact on the marketing authorisation; 2° A scientific evaluation of th…
…t, refer the matter to the Committee for Medicinal Products for Human Use referred to in Article 56 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or to the coordination…
…0 implements procedures to obtain accurate and verifiable information for the scientific evaluation of suspected adverse reaction reports, collects follow-up information concerning these reports and s…
The head pharmacist and the delegate pharmacist(s) of the companies or organisations mentioned in 1° and 2° of article R. 5124-2 must provide evidence of at least two years' practical experience in on…
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