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Showing 7841–7850 of 26972 articles for “Art. CE 16-4-2012 n° 323592”
…s well as users, and in particular medical biology analysis laboratories, shall transmit to the Agence nationale de sécurité du médicament et des produits de santé any information on unexpected or und…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may also suspend, for a period not exceeding one year, or revoke a marketing auth…
…nt, automatically vary, refuse, renew or revoke marketing authorisations subject to the national procedure are taken in accordance with the procedures laid down in Article R. 5141-27 relating to the e…
…the marketing authorisation must state the reasons on which it is based and indicate the appeal procedures and deadlines. Except in cases of urgency, the decision may only be taken after the marketin…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may automatically vary a marketing authorisation for a veterinary medicinal produ…
…modify or withdraw authorisations and as a precautionary measure, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may prohibit…
…relating to the trials to the Ministers of Agriculture and Health, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail and the inspe…
The procedures for submitting and examining applications for authorisation to open, for modification of initial authorisations and for transfer of authorisations to open, as provided for in articles R…
…ackaging; 3° Batch monitoring, complaints handling, product withdrawals and returns, pharmacovigilance operations.
A veterinary pharmaceutical establishment which manufactures medicinal products mentioned in 1° of article R. 5142-1 has a documentation system comprising specifications, manufacturing formulae, proce…
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