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Showing 1761–1770 of 6154 articles for “Art. 13 Mar 2020”
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…
The authorisation holder shall inform the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail of the date on which the activity of prepar…
…where it appears : 1° That there is one or more immunological veterinary medicinal products with a marketing authorisation for the species in question containing one or more of the pathogens listed o…
…avail ninety days before the authorisation expires. This application for renewal includes : 1° A summary analysis of the pharmacovigilance data drawn up on the basis of the reports provided for in Art…
…niques mentioned in a, c and d of the technical dossier provided for in 3° of II of Article R. 5141-130 are modified in line with scientific and technical progress.
I.-The qualified person shall send the application for authorisation provided for in Article L. 5141-12 to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'en…
In the event of a change of ownership of a veterinary pharmaceutical establishment, the authorisation to open is transferred to the new owner on application made jointly by the two responsible pharmac…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail will notify the applicant of his decision within one hundred and twenty days from…
…five years; it is renewable for five-year periods under the conditions laid down in article R. 5141-137 of the same code. It mentions the surname, first name and position of the authorisation holder,…
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