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Showing 9751–9760 of 21091 articles for “Art. CA Paris 20-5-2009 n° 08-2432”
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…
…er must, with regard to the manufacturing and control methods, take account of scientific and technical progress and introduce any changes necessary to ensure that the medicinal product is manufacture…
…rketing 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 the pres…
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 existence of an adequate pharmacovigilance system; 6° The performance of post-authorisation efficacy studies when additional data is required after the medicinal product or product has been placed…
…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 out the appeal procedures and ti…
…sation granted before 21 July 2012, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by reasoned decision notified in writing, where he has concerns…
…er is subject to authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé.The application must include the information specified in Article R.…
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…
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