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Showing 2711–2720 of 59096 articles for “Art. s. 815-9 and 815-13”
Any modification concerning the elements and documents mentioned in Article R. 5141-130 is submitted for authorisation to the Director General of the Agence nationale de sécurité sanitaire de l'alimen…
Decisions to authorise, modify, renew, suspend or withdraw authorisation for the preparation of autovaccines are made public in an extract on the website of the Agence nationale de sécurité sanitaire…
The labelling of self-vaccines for veterinary use and, where appropriate, the accompanying information sheet must include, in addition to the words: "self-vaccine for veterinary use" in clearly visibl…
…t du travail of the date on which the activity of preparing autovaccines for veterinary use commences. It shall also inform him of the definitive cessation of this activity.
…alth or the environment; 3° That the conditions of conservation of strains, preparation, monitoring and, where applicable, transport of auto-vaccines for veterinary use do not comply with the conditio…
…aire de l'alimentation, de l'environnement et du travail ninety days before the authorisation expires. This application for renewal includes : 1° A summary analysis of the pharmacovigilance data drawn…
After the authorisation provided for in Article L. 5141-12 has been issued, the preparation methods and control techniques mentioned in a, c and d of the technical dossier provided for in 3° of II of…
…tion providing the facilities, where applicable; 4° The list of pathogens by species of destination and the pharmaceutical forms envisaged. II - The application must be accompanied by a dossier contai…
…tion, de l'environnement et du travail will notify the applicant of his decision within one hundred and twenty days from the date of receipt of the complete application. Silence on the part of the Dir…
…e conditions laid down in article R. 5141-137 of the same code. It mentions the surname, first name and position of the authorisation holder, the name of the company or the name of the organisation wh…
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