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Showing 11911–11920 of 38939 articles for “Art. al. 4”
When a new indication is authorised by the Agence nationale de sécurité du médicament et des produits de santé, on the basis of preclinical and clinical studies considered significant during the scien…
In the event of agreement within the coordination group, referred to by the Director General of the Agence nationale de sécurité du médicament et des produits de santé or by another State : 1° In the…
…121-8, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing auth…
…tary medicinal product and withdraw it from the market on the grounds mentioned in Article L. 5121-14-2. The decision must state the reasons on which it is based and, except in an emergency, may only…
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…
…ng the marketing authorisation application dossier; 3° Seek the opinion of experts appointed by it; 4° Appoint rapporteurs to ensure that applications comply with the provisions of this Code; 5° Requi…
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…
…able, its code name or international non-proprietary name, its pharmaceutical form and its strength;4° The therapeutic indication for which this medicinal product is prescribed for the patient in ques…
I.-The early access authorisation may be renewed. Renewal is the subject of an application by the holder of this authorisation addressed to the Haute Autorité de santé, the ministers responsible for h…
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…
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