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Showing 691–700 of 33010 articles for “Art. R 581-13”
The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorisation holders and authorised persons. These lists are accessible at…
Decisions to authorise, modify, renew, suspend or withdraw authorisation for the preparation of autovaccines are made public in an extract on the website of the Agence nationale de sécurité sanitaire…
The labelling of self-vaccines for veterinary use and, where appropriate, the accompanying information sheet must include, in addition to the words: "self-vaccine for veterinary use" in clearly visibl…
The authorisation holder shall inform the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail of the date on which the activity of prepar…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail will notify the applicant of his decision within one hundred and twenty days from…
The presentation, at scientific or technical meetings, exhibitions or demonstrations, of medical devices which do not comply with the provisions of this Title is authorised provided that a visible sig…
The presentation at scientific or technical meetings, exhibitions and demonstrations of in vitro diagnostic medical devices which do not comply with the provisions of this Title is authorised provided…
Every manufacturer of medical devices, or its authorised representative, appoints a material vigilance correspondent and communicates his name to the Director General of the Agence nationale de sécuri…
The granting of a nuclear medicine activity authorisation is subject to compliance with the applicable provisions of Chapter III of Title III of Book III of Part One of this Code.
The nuclear medicine authorisation includes one of the following entries: 1° "A" entry, when the activity includes diagnostic or therapeutic procedures, excluding cancer therapy, performed by administ…
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