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Showing 1611–1620 of 49594 articles for “Art. Cass. 3e civ. 4-3-1998 n° 96-16.671”
The diplôme d'Etat de puéricultrice is awarded by the préfet de région to holders of a nursing or midwifery diploma validated for the practice of the profession in France, who have passed the competit…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by a reasoned decision setting out the appeal procedures and deadlines, automatically vary, suspend…
The specific obligations which may be imposed pursuant to the third paragraph of Article L. 5121-9 and which must be mentioned in the risk management system are, in particular, the following: 1° The a…
The marketing authorisation is renewable on application by the holder to the National Agency for the Safety of Medicines and Health Products no later than nine months before its expiry date. The appli…
In the case of blood-derived medicinal products, the Agence nationale de sécurité du médicament et des produits de santé may, when examining the application for marketing authorisation, submit samples…
When, on the occasion of the implementation of Article 20(4) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, urgent action is essential to protect human…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may prohibit the prescription and supply of a proprietary medicinal product and withdraw it from the mar…
Any change in 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 i…
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…
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…
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