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Showing 8951–8960 of 30818 articles for “Art. Cass. 3e civ. 28-5-1997 n° 95-17.953”
After the marketing authorisation has been granted, the authorisation holder must, with regard to the manufacturing and control methods, take account of scientific and technical progress and introduce…
The marketing authorisation is granted by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The authorisation includes the national number identifying th…
The marketing authorisation may impose one or more of the following conditions, which must be mentioned in the risk management system: 1° The implementation of measures to ensure the safe use of the m…
1° In the interests of patients or for any other public health reason and, where appropriate, at the request of the Minister for Health, the Director General of the Agence nationale de sécurité du méd…
Following the granting of a marketing authorisation, including for an authorisation granted before 21 July 2012, the Director General of the Agence nationale de sécurité du médicament et des produits…
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…
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…
When the scale of the activity of the pharmacy for internal use so requires, and in any event in order to carry out these activities on each of the sites of the pharmacy for internal use, the Minister…
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