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Showing 5281–5290 of 70899 articles for “Art. I-1° and II”
…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…
…nished product when it is imported : 1° From a State that is not a member of the European Community and not party to the Agreement on the European Economic Area ; 2° Or from another Member State of th…
Manufacturers of medicinal products mentioned in 1° of article L. 4211-1 and manufacturers of generators, kits or precursors mentioned in 3° of the same article must justify, at all times, that all th…
…cts of major therapeutic interest referred to in article L. 5111-4, marketing authorisation holders and pharmaceutical companies exploiting medicinal products shall, under their responsibility, draw u…
I.-Any marketing authorisation holder and any pharmaceutical company exploiting a medicinal product in France shall build up a safety stock intended for the national market referred to in article L. 5…
…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…
…The rules of procedure determine the rights of duly constituted groups of elected representatives and the specific rights of minority groups or those that have declared themselves to be in oppositio…
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