Article R5121-168
I.-Any company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150 is required to transmit electronically to the European Medicines Agency a periodic safety up…
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Showing 5291–5300 of 56962 articles for “Art. Cass. 3e Civ. 1-10-2014 n° 13-16.806”
I.-Any company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150 is required to transmit electronically to the European Medicines Agency a periodic safety up…
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…
Pharmaceutical establishments, including those managed by public health establishments mentioned in articles R. 5124-68 to R. 5124-73 for their production, hospital preparation and magistral preparati…
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…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 implements procedures to obtain accurate and verifiable information for the scientific evaluati…
The in-house pharmacies referred to in Article L. 5126-1 shall forward to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, immediately upon request, a r…
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…
I.-This article applies to the post-authorisation studies referred to in article R. 5121-178 which are carried out by the holder of the authorisation referred to in article L. 5121-8 in order to compl…
…etermination of the rental value of industrial fixed assets whose ownership is, pursuant to the loi n° 2014-872 du 4 août 2014 portant réforme ferroviaire, transférée à la SNCF ou à SNCF Réseau, le pr…
…cluded in the area of competence of a community development syndicate created in application of loi n° 70-610 du 10 juillet 1970, may decide, by a deliberation taken before 1 July 1986, that all resid…
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