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Showing 8051–8060 of 18481 articles for “Art. CE 5-5-2010 n° 301419”
…lementation of measures to ensure the safe use of the medicinal product or product; 2° The performance of post-authorisation safety studies; 3° Compliance with specific obligations regarding the recor…
…and, where appropriate, at the request of the Minister for Health, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by a reasoned decision setting…
…sation, including for an authorisation granted before 21 July 2012, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by reasoned decision notified i…
…the marketing authorisation holder is subject to authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé.The application must include the inf…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse the marketing authorisation on the grounds mentioned in Article L. 5121-9. The application…
For public health reasons, the Agence nationale de sécurité du médicament et des produits de santé may require a company to submit samples of each batch of the bulk product and the finished product fo…
The marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any proposed amendment to the labelling or package le…
…y out these activities on each of the sites of the pharmacy for internal use, the Minister for Defence shall appoint one or more pharmacists covered by the provisions of article L. 4138-2 of the Defen…
…y the provisions of article L. 4138-2 of the Code de la Défense, appointed by the Minister for Defence, manages the pharmacy for internal use of the pharmacie centrale des armées. This pharmacist pers…
Whatever the cause and duration of the absence of the pharmacist in charge of the pharmacy for internal use, his replacement may not exceed one year. This replacement is carried out by a pharmacist co…
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