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Showing 5191–5200 of 37344 articles for “Art. R. 612-7”
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de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn…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…
The bodies responsible for carrying out the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of any change likely to alter the conditions under which authorisation ha…
…heck the manufacturing processes. The decision of the authorised body is notified to the manufacturer. It contains the conclusions of the inspection and a reasoned assessment. In all cases, the approv…
…t ensure that the provisions of Book II of Part V of this Code are complied with by the subcontractor. The approved body must make available to the Director General of the Agence nationale de sécurité…
…evices with an approved type described in an EC type-examination certificate referred to in Article R. 5211-41 or with the technical documentation referred to in Article R. 5211-39 under the condition…
…is article concerning medical devices and active implantable medical devices referred to in Article R. 5211-23-1, the authorised body shall examine at least the aspects provided for in point 2.2 of An…
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