Article R5121-45
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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Showing 7681–7690 of 39773 articles for “Art. R. 145-5”
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…
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…
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…
…When the Director General of the Agency makes use of the option granted to him under 5° of Article R. 5121-34, these time limits are suspended until the additional information required has been provi…
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…
…tific methods. These modifications must first be authorised under the conditions set out in article R. 5121-41-1.
…s the national number identifying the presentation of the medicinal product provided for in Article R. 5121-4. It indicates, where applicable, the classification of the medicinal product in the follow…
…dicament et des produits de santé.The application must include the information specified in Article R. 5121-21 and must be accompanied by a dossier comprising :1° A copy of the marketing authorisation…
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