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Showing 1111–1120 of 35236 articles for “Art. R 581-8”
A proprietary medicinal product covered by the regulations on poisonous substances may not be unpackaged by the dispensing pharmacist with a view to its incorporation into a magistral preparation.This…
For reasons of public health, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may require a company exploiting an immunological v…
The purpose of veterinary pharmacovigilance is to monitor the effects of veterinary medicinal products, mainly their adverse effects on animals and humans, and the scientific evaluation of information…
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…
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…
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.
The Board of Directors meets at least three times a year when convened by its Chairman. The meeting is convened by right within thirty days of a request made by the Minister for Health, by the Chief E…
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