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Showing 1711–1720 of 52053 articles for “Art. II-5°”
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.
The specific obligations which may be imposed pursuant to the third paragraph of Article L. 5121-9 and which must be mentioned in the risk management system are, in particular, the following: 1° The a…
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…
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…
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