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Showing 5051–5060 of 33647 articles for “Art. 1231 to 1231-7”
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…
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de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn…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…
…rocedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé published on…
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…
…s or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees conformity of the medical devices manufactured w…
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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