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Showing 8901–8910 of 19750 articles for “Art. CE 25-5-1988 n° 81512”
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…
…e environment, pending a final decision by the European Commission, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend the use of a medicinal p…
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…
…the manufacturing and control methods, take account of scientific and technical progress and introduce any changes necessary to ensure that the medicinal product is manufactured and controlled in acco…
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…
…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…
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