Article R5121-168
…a periodic safety update report containing : 1° All information relating to the benefits and risks associated with this medicinal product or product, including the results of studies which may have a…
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Showing 2711–2720 of 23743 articles for “Art. Cass. 13 March 2008 – counterfeit as dispossession”
…a periodic safety update report containing : 1° All information relating to the benefits and risks associated with this medicinal product or product, including the results of studies which may have a…
The marketing authorisation holder may, by written reasoned request, refer the matter to the Committee for Medicinal Products for Human Use referred to in Article 56 of Regulation (EC) No 726/2004 of…
…tion of 3° and 5° and R. 5121-165. They report electronically to the European "Eudravigilance" database: 1° Any serious adverse reaction suspected to be due to the hospital and magistral preparations…
The declarations and the periodic safety update report referred to in Articles R. 5121-161, R. 5121-168 and R. 5121-170 are drawn up in accordance with the procedures and standard form laid down by th…
…p information concerning these reports and sends new elements to the European "Eudravigilance" database. Any company or organisation exploiting a medicinal product or a product mentioned in Article R.…
…ons which they have reported or which have been reported to them and all the information useful for assessing the risks and benefits associated with the use of the hospital preparations and magistral…
The procedures and standard form for the declarations and report mentioned in Articles R. 5121-174 to R. 5121-176 are laid down by decision of the Director General of the Agence nationale de sécurité…
The Minister of Justice is authorised to implement automated processing of personal data known as "Redex" (Répertoire des Expertises), consisting of the directory of personal data collected in the con…
I.-The merchants referred to in article L. 121-1 of the French Commercial Code may provide cash to the Payment Service User as part of a payment transaction for the purchase of goods or services. II-T…
Life cycle costing covers, insofar as they are relevant, all or some of the following costs in the life cycle of a product, service or work:1° Costs borne by the purchaser or other users, such as :a)…
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