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Showing 8281–8290 of 18228 articles for “Art. 5° ter”
After the marketing authorisation has been granted, the marketing authorisation holder must immediately forward to the National Agency for the Safety of Medicines and Health Products, indicating the s…
After a marketing authorisation has been granted, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may require the marketing authorisation holder to carr…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may require samples and mock-ups to be submitted when the medicinal product is marketed.
…nformation on the efficacy and safety of the medicinal product under normal conditions of use are determined by order of the Minister for Health, on a proposal from the Director General of the Nationa…
…plication 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 application for renewal is accompanied by a consoli…
…ubmit samples either of the bulk product and the finished product, or of one of them only. In the interests of public health, the Agence nationale de sécurité du médicament et des produits de santé ma…
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…
…by it; 4° Appoint rapporteurs to ensure that applications comply with the provisions of this Code; 5° Requiring the applicant to complete its dossier, in particular with regard to reports on analytic…
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…
…lication file. 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…
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