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Showing 5411–5420 of 61408 articles for “Art. 5 and 6”
In order to extend the composition of the user undertaking's health, safety and working conditions committee to include representation from external undertakings, in application of article L. 4523-11,…
Establishments and authorised organisations shall implement a procedure for the withdrawal of advanced therapy medicinal products prepared on an ad hoc basis in accordance with the rules of good pract…
…cerned, which holds a manufacturing or import authorisation for such medicinal products or products and which monitors these batches for France. The authorisation holder keeps these authorities inform…
…nefiting from the authorisations or registration provided for in the second paragraph of Article R. 5124-49 is subject, in France, to control of the finished product when it is imported : 1° From a St…
…is article has a documentation system comprising specifications, manufacturing formulae, procedures and statements, reports and records covering the various operations it carries out. For medicinal pr…
…of an incident or accident which has occurred during the manufacture or distribution of this batch and which may result in a risk to public health, he shall immediately notify the Director General of…
The provisions of articles R. 5124-49 to R. 5124-55 are applicable to manufacturers and importers of dressing articles or articles presented as complying with the pharmacopoeia mentioned in 2° of arti…
The manufacturer and importer of medicinal products mentioned in 1° of article L. 4211-1, or of generators, kits or precursors mentioned in 3° of the said article, shall implement a pharmaceutical qua…
…this termination within thirty days:1° To the Regional Director of the Economy, Employment, Labour and Solidarity via the dematerialised service mentioned in the second paragraph of article D. 6325-1…
The cooperative for activity and employment keeps, for each autonomous economic activity: 1° An analytical balance sheet account which summarises the assets and liabilities; 2° An analytical profit an…
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