Article R1245-21
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…
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Showing 6181–6190 of 37208 articles for “Art. R 134-7”
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…
I. - The application for authorisation provided for in the second paragraph of I of Article L. 1245-5 for products from Member States of the European Union or parties to the Agreement on the European…
For the purposes of this section, the following definitions shall apply:1° Unique European code: unique identifier applied to tissues and cells circulating in the European Union. This code is composed…
The single European code is allocated to all tissues, their derivatives and cells or cell therapy preparations used for therapeutic purposes, regardless of their country of origin, prior to their dist…
An order of the Minister for Health made on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the Director…
External radiotherapy is a cancer treatment method that uses ionising radiation to destroy cancer cells using rays produced by a linear particle accelerator, while sparing peripheral healthy tissue as…
Establishments are not subject to authorisation for cancer treatment when they provide: 1° Surgery to diagnose cancer; 2° For patients with an established cancer diagnosis, surgery to treat or allevia…
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