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Showing 13851–13860 of 39711 articles for “Art. al. 3”
…en to carry out the tests with a view to compiling the marketing authorisation application dossier; 3° Seek the opinion of experts appointed by it; 4° Appoint rapporteurs to ensure that applications c…
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…
…s the reference State, the application is examined under the conditions set out in Articles R. 5121-34 and R. 5121-35. The Director General of the Agency sends the States concerned and the applicant a…
…sibly in a hospital environment and, in the case of a radiopharmaceutical, by an authorised person; 3° The package leaflet and any medical information must draw the doctor's attention to the fact that…
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.
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…
…ished by Article 26 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004.The holder shall inform the Director General of the Agency and the European Medicines…
…lated and to matters falling within the remit of the Disciplinary Board or concerning its operation;3° The circular is sent at the same time as the declaration of candidacy to the State representative…
…ate representative checks that the declaration of candidacy is in order, pursuant to articles D. 4443-23 and D. 4443-24. He checks that the candidates meet the conditions defined in article D. 4443-20…
Subject to the provisions of articles L. 1123-6 to L. 1123-8 and L. 1123-13 and those adopted for their application, the investigators and persons called upon to collaborate in the trials are bound by…
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