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Showing 2701–2710 of 23743 articles for “Art. Cass. 13 March 2008 – counterfeit as dispossession”
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…
…R. 5121-151, with a view to preventing and reducing risks and, if necessary, to take appropriate measures. Any company or organisation exploiting a medicinal product or a product mentioned in Article…
…ing a post-authorisation study; 2° To report, electronically, to the European "Eudravigilance" database: a) Any suspected serious adverse reaction occurring in a Member State of the European Union, a…
…any 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 pharmacovigilance r…
…et des produits de santé: 1° Any serious adverse reaction suspected to be due to the allergens he has prepared and supplied, of which he is aware, without delay and no later than fifteen days followi…
…irector General of the Agence nationale de sécurité du médicament et des produits de santé that it has taken action to suspend the marketing of a medicinal product or a product or to withdraw it from…
…Agence nationale de sécurité du médicament et des produits de santé: a) When the Director General has concerns regarding pharmacovigilance data; b) Or when there is no periodic safety update report f…
If the coordination group agrees, at the end of the single assessment procedure for periodic safety update reports provided for in Article 107g(1) of Directive 2001/83/EC of the European Parliament an…
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