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Showing 7001–7010 of 20363 articles for “Art. CE 18-5-1998 n° 179831”
…he event of agreement within the coordination group, referred to by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail or by another…
…roduct from another Member State shall inform the marketing authorisation holder and notify the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail of his intent…
…must meet one of the following qualification requirements: 1° Hold one of the diplomas, titles or certificates at least equal to level III registered in the national register of professional qualifi…
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…
…ion 2 of Chapter VII of Title II of Book I of this Part are applicable to the inspectors of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail mentioned in…
By way of derogation from the provisions of article R. 5212-35-4, where the second-hand medical device being transferred has never been put into service, the file is composed solely of the following e…
The certificate of compliance with good practice relating to raw materials for pharmaceutical use is issued in accordance with Articles R. 5138-3 to R. 5138-6. When the inspection reveals serious brea…
I.-The statutory auditor will only receive, through the intermediary of a doctor acting under his responsibility as an expert, the personal data mentioned in article R. 6113-1 which are necessary to v…
I.- External service providers who assist the doctor responsible for medical information in the performance of his duties under article R. 6113-4 may only access, under the latter's responsibility and…
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