Article R5141-80
Each sample consists of two samples. One sample is sent to the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (French National Agency for Food, Environmenta…
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Showing 3021–3030 of 9215 articles for “Art. 8 janv. 1997”
Each sample consists of two samples. One sample is sent to the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (French National Agency for Food, Environmenta…
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 ninety days from the date of rec…
Each committee comprises : 1° Three representatives of the State and one representative of the Regional Health Agency: a) The Regional Prefect or his representative, Chairman ; b) The Regional Directo…
If a medical device is intended to be used in conjunction with another medical device, the classification rules apply separately to each device. Computer software controlling a device or influencing i…
The penalty decision may, where appropriate, be accompanied by a daily penalty payment. This penalty payment is notified in accordance with the same procedural rules as the main sanction. The amount o…
Without prejudice to the provisions of Article R. 5221-9, in vitro diagnostic medical devices which comply with the standards relating to them and transposing the harmonised European standards, the re…
The authorisation is issued for a period of five years. At the request of the holder, submitted no later than two months before the normal expiry date, the initial authorisation is renewed for a perio…
The authorisation is issued for a period of five years. At the request of the holder, submitted no later than two months before the normal expiry date, the initial authorisation is renewed for a perio…
The provisions of Section 2 of Chapter VII of Title II of Book I of this Part are applicable to the inspectors of the Agence nationale de sécurité du médicament et des produits de santé.
I.-The examination by the Agence nationale de sécurité du médicament et des produits de santé of the application for a certificate of good manufacturing practice provided for in Article R. 5131-2 of t…
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