Article R5121-169
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…
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Showing 9991–10000 of 66941 articles for “Art. s. L 313-38 and R 313-22”
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…
Title I of Book V of this Part shall apply in the Territory of Wallis and Futuna as amended by Order No 2016-623 of 19 May 2016 transposing Directive 2014/40/EU on the manufacture, presentation and sa…
Subject to the adaptations provided for in this Title, the following provisions shall apply in the Wallis and Futuna Islands to concession contracts entered into by the State or its public establishme…
I. - In the event of the creation of a new commune grouping together all the communes that are members of one or more public establishments of inter-communal cooperation with its own tax status, the d…
Subject to the adaptations provided for in this Title, the following provisions shall apply in the French Southern and Antarctic Lands to concession contracts concluded by the State or its public esta…
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