Article R6332-114
The formal notice provided for in Article L. 6332-24 is issued by the Regional Prefect.
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Showing 9811–9820 of 64913 articles for “Art. R 315-5 and Art. R 315-7 s.”
The formal notice provided for in Article L. 6332-24 is issued by the Regional Prefect.
For the application of 1° of Article L. 5126-5, an agreement is concluded between the establishment to which the in-house pharmacy belongs and the healthcare professional or the biologist responsible…
For the supply of maritime companies operating ships, in application of 4° of article L. 5126-5, pharmacies for internal use may supply pharmacies with medicines reserved for hospital use, on presenta…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn…
The approved body may require the manufacturer to provide any information and to carry out any test or assessment necessary for it to carry out the verifications for which it is responsible.
Where an authorized body finds that the requirements of this Title applicable to this device have not been met or are no longer being met by the manufacturer, or where a certificate should not have be…
In the case of active implantable medical devices or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees…
As part of the EC verification procedure, the manufacturer submits the devices manufactured for inspection by an authorised body. The authorised body checks the conformity of the medical devices with…
The decisions taken by the approved bodies under the procedures referred to in subsections 5, 6, 8 and 9 of section 6 of this chapter are valid for five years. They may be renewed for five-year period…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-43 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
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