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Showing 3881–3890 of 12836 articles for “Art. 7 mars 2012”
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…
In each region, a commission is responsible for issuing an opinion on animal health programmes and proposing the approval of the groups designated in the first paragraph of article L. 5143-6.
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…
…tion 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 may refuse to supply these products, prescr…
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…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his prior authorisation decision within two months of the date of receipt o…
In carrying out checks on the application of the provisions of Title II of Book I of Part I and the regulatory measures taken for its application falling within the remit of the Agence nationale de sé…
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