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Showing 6841–6850 of 28173 articles for “Art. Cass. 3e civ. 7-7-2015 n° 14-11.644”
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…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may grant, under the conditions laid down in Article R. 5211-55 and Article 4 of Implementing Regulation…
The General Director of the Agence nationale de sécurité du médicament et des produits de santé regularly checks that the authorised body has the required skills and up-to-date knowledge of the medica…
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de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn…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…
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…
I.-The approved bodies must comply with the following obligations: 1° The approved body, its director and the personnel responsible for carrying out the assessment and verification operations may not…
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