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Showing 2871–2880 of 6535 articles for “Art. CA Rennes – 17 Dec. 2024 – no. 23/05277”
…onditions requiring the beneficiary of the authorisation to implement a plan for monitoring the efficacy and safety of the medicinal product, including the periodic collection of information concernin…
I. - The application for authorisation of an individually prepared advanced therapy medicinal product is accompanied by a dossier, the content of which is laid down by decision of the Director General…
…on may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. Except in cases of urgency relating to the safety of individuals, t…
…authorisation must be submitted for any changes which have an impact on the quality, safety and efficacy of the medicinal product. This application must be accompanied by a technical dossier, the mode…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within a maximum of one hundred and twenty days from the date…
…horise the judicial representative appointed in the main insolvency proceedings opened by a court located on the national territory to make, pursuant to Article 36 of the aforementioned Regulation (EU…
A decree in Council of State shall specify the conditions of application of this chapter.
…prosecutor, by way of appeal, and any creditor, by way of appeal or third party opposition, as the case may be, may challenge the decision to open the main insolvency proceedings on a ground of inter…
The court shall rule on challenges raised or applications made, in accordance with paragraphs 7 or 8 of Article 36 of the aforementioned Regulation (EU) No 2015/848, by the local creditors of an estab…
The court is seised by petition of challenges raised or applications made pursuant to Article L. 691-3. The court rules on the application after hearing or duly calling in chambers the debtor who has…
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