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Showing 8021–8030 of 17844 articles for “Art. 815-5”
The Minister for Health may, on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, require by order that companies exploiting certain immunolo…
During the examination of marketing authorisation applications, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may order any investigative measure he d…
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 will make a decision within two hundred and ten days of the submission of a complete application file. W…
The marketing authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé lapses if it transpires that: 1° That it is not followed by the marketing of the medicinal…
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…
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…
When a medicinal product has obtained an initial marketing authorisation in accordance with Article L. 5121-8, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No…
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…
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