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Showing 4791–4800 of 35281 articles for “Art. R 315-8”
I. - The application for authorisation or renewal of authorisation of an establishment or organisation to carry out the activities referred to in Article R. 4211-32 relating to advanced therapy medici…
The person in charge referred to in Article R. 4211-37, the interim persons in charge, the person in charge of site activities and the interim person in charge of site activities must hold the qualifi…
I. - With the exception of the establishments and organisations mentioned in II and III, any establishment or organisation benefiting from the authorisation provided for in this section shall put in p…
I. - The provisions of this section apply to the categories of establishments or organisations defined in the second paragraph of this article which meet the conditions for obtaining the authorisation…
To avoid any risk of cross-contamination, where storage, preparation and transfer activities for scientific purposes are carried out on the same premises as those dedicated to the preparation, storage…
Article R. 249-8 is worded as follows: "Art. R. 249-8.-An appeal against the decision may be lodged with the court mentioned in a and b of Article R. 249-6 by the Public Prosecutor's Office at the req…
Manufacturers of in vitro diagnostic medical devices may procure tissues, their derivatives and cells from the human body, whatever their level of processing, in a Member State of the European Union o…
I. - The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within three months of the date on which the application…
The Agence nationale de sécurité du médicament et des produits de santé has a period of four months to evaluate the information provided. At the end of these maximum four months, when, in application…
Pursuant to the fourth paragraph of the I of Article L. 1245-5, when the elements or products mentioned in Article R. 1245-1 do not benefit from the authorisation mentioned in Article L. 1243-2, estab…
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