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Showing 12851–12860 of 15302 articles for “Art. 12 al. 2”
…ed in compliance with the rules of good practice provided for in the third paragraph of Article L. 5121-5 ; 3° Organising and monitoring the application of the pharmacovigilance system. With the excep…
The Director General of the Centre national de gestion, acting on behalf of the Minister for Health, shall rule on the application for authorisation to practise referred to in article L. 4151-5-1 in a…
Articles R. 1243-4 to R. 1243-10 and R. 1243-12 to R. 1243-14 are applicable to establishments or organisations carrying out the activities of preparation, storage, distribution or transfer of gene th…
…e midwife must take into account the summary of product characteristics provided for in article R. 5121-21 and in particular the indications, any contraindications and data relating to pregnancy and b…
…ordance with the rules of good practice provided for in the first or third paragraph of Article L. 5121-5 and, where applicable, in accordance with the containment requirements adopted in application…
…with acknowledgement of receipt. The dossier shall include the information mentioned in Article R. 1243-4 and an attestation that the gene therapy preparations or xenogenic cell therapy preparations…
…t, arranged and maintained in accordance with the rules of good practice referred to in Article L. 5121-5 and, where applicable, in accordance with the containment requirements adopted pursuant to Art…
…ysis of the pharmacovigilance data drawn up on the basis of the reports provided for in article R. 5121-176 drawn up during the previous five-year period ; 2° An updated dossier and certification by t…
…c cell therapy preparations must comply with the rules of good practice provided for in Article L. 5121-5 and the requirements mentioned in the authorisation provided for in 12° and 13° of Article L.…
…ing of I of article L. 541-10 of the Environment Code, the operators mentioned in 3° of article R. 5124-2 of the Public Health Code; 2° "Unused medicinal products" means unused or out-of-date medicina…
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