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Showing 4321–4330 of 18903 articles for “Art. D 815-7”
The inclusion of an information leaflet for the user in the packaging of a medicinal product is compulsory, unless the information mentioned in article R. 5141-77 appears directly on the outer packagi…
Ampoules and other small primary packagings on which it is impossible to include all the particulars provided for in Article R. 5141-73 may include only the following information: 1° The name of the m…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail shall inform the Prefect of the département in which the establishment is located…
In the absence of observations or in the event of an inadequate response to the complaints within the time limit mentioned in the previous article, the Director General of the Agence nationale de sécu…
For the purposes of this Title, medical devices other than active implantable medical devices are divided into four classes known as Class I, Class IIa, Class IIb and Class III. Whether a device belon…
In the event of disagreement on the application of the classification rules between the manufacturer of an in vitro diagnostic medical device and an authorised body involved in the conformity assessme…
The regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
Prescriptions for medical devices issued at the request of a patient with a view to obtaining a supply in another Member State of the European Union must include the following information: 1° The surn…
When the prescription includes the information provided for in 1°, subject to adaptation of the country information, to 3° of Article R. 5211-70, persons legally authorised to supply medical devices m…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision on prior authorisation within two months of the date of receip…
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