Article R5139-8
I. - In addition to the cases mentioned in article R. 5139-3-1, authorisation is also refused if the operation or operations envisaged in the application present or are likely to present a risk to pub…
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Showing 3371–3380 of 40119 articles for “Art. L. 145-8”
I. - In addition to the cases mentioned in article R. 5139-3-1, authorisation is also refused if the operation or operations envisaged in the application present or are likely to present a risk to pub…
The nurse will seek out the most appropriate methods, depending on the age and personality of the pupil, in order to inform her of the various possibilities for emergency contraception and to point he…
…ral of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail. It is enclosed in a sealed bag and labelled with the name of the medicinal product or constituent…
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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