Article R5124-57-2
The manufacturer or importer of investigational medicinal products shall ensure that all manufacturing operations are carried out in accordance with the information provided by the sponsor in the appl…
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Showing 4121–4130 of 64661 articles for “Art. R 210-5 and R 210-6”
The manufacturer or importer of investigational medicinal products shall ensure that all manufacturing operations are carried out in accordance with the information provided by the sponsor in the appl…
The General Director of the Agence nationale de sécurité du médicament et des produits de santé regularly checks that the authorised body has the required skills and up-to-date knowledge of the medica…
Notwithstanding the provisions of Article R. 5222-18-4, where the second-hand in vitro diagnostic medical device which is the subject of the transfer has never been put into service, the file consists…
In the event of a breach of the requirements resulting from III of Article L. 2151-6, the Director General of the Agence de la biomédecine may give formal notice to the establishment or organisation t…
I.-The statutory auditor will only receive, through the intermediary of a doctor acting under his responsibility as an expert, the personal data mentioned in article R. 6113-1 which are necessary to v…
This notice shall specify the nature of the meeting and include the items and the text of the draft resolutions that the company intends to include on the agenda of the meeting. The notice shall also…
Unless there is a risk to patients' health, proprietary medicinal products which fulfil the conditions for being a reference proprietary medicinal product in an existing hybrid group may, by decision…
Within one month of receipt of the letter provided for in article R. 160-4, the opposing party must bring his action before the competent court and notify the company, by electronic registered mail wi…
Each financial holding company of the liberal profession of industrial property attorney is subject, by the Director General of the National Institute of Industrial Property, as soon as it is register…
Failing an express decision within the time limit mentioned in Article R. 721-6, the application for approval or amendment of the specification is deemed to have been rejected.
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