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Showing 2841–2850 of 64020 articles for “Art. 815-3 and 815-5”
The commission may only validly deliberate if the number of members present is at least equal to two-thirds of the number of members called upon to deliberate. If this number is not reached, a new not…
The commission may only validly deliberate if the number of members present is at least equal to two-thirds of the number of members called upon to deliberate.If this number is not reached, a new noti…
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…
…sation advanced therapy medicinal products prepared on an ad hoc basis with a view to their storage and distribution or components of these medicinal products with a view to their preparation by this…
…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…
…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…
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