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Showing 9481–9490 of 20363 articles for “Art. CE 18-5-1998 n° 179831”
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.
…hin a period set by the Agency, the results of which will be used to reassess the benefit/risk balance of the medicinal product as defined in the first paragraph of article L. 5121-9 ; 2° It must be p…
…dverse reactions and in the periodic safety update reports, as well as any authorised variations since the initial authorisation or the previous renewal. The content of the dossier is laid down by ord…
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…
…Agency for the Safety of Medicines and Health Products, require by order that companies exploiting certain immunological medicinal products mentioned in article L. 5121-1 submit to the National Agenc…
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…
…e environment, pending a final decision by the European Commission, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend the use of a medicinal p…
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…
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…
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