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Showing 9711–9720 of 43105 articles for “Art. R. 211-4”
…environnement et du travail. Registration decisions include the information provided for in Article R. 5141-63.
Amendments concerning the data mentioned in the application and dossier provided for in articles R. 5141-63 and R. 5141-64 are submitted for approval to the Director General of the Agence nationale de…
…observed or which has been brought to their attention or any other information mentioned in article R. 5141-90 which has been brought to their attention. The same applies to any member of a healthcare…
…ntation of the decentralised procedure or the mutual recognition procedure provided for in articles R. 5141-47-1 et seq., any company exploiting a veterinary medicinal product authorised under one of…
The declaration and reporting obligations laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulati…
…rd form for the declarations and the periodic pharmacovigilance update report mentioned in articles R. 5141-103 to R. 5141-105-1 are laid down by decision of the Director General of the Agence nationa…
…State of the European Union; 3° Annually for the following two years; 4° Every three years thereafter. After the marketing authorisation has been granted, the company responsible for the operation of…
…conformity of the medical device with the essential requirements set out in Section 5 of this Chapter.The manufacturer shall establish and keep up to date a systematic procedure for examining the data…
The animal health decision taken in application of article L. 5145-2-1 or article L. 5145-2-2 is published on the website of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environn…
…vitro diagnostic medical device with the essential requirements set out in Section 5 of this Chapter. He shall specify the principles for ensuring the quality of his production and guarantee that his…
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