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Showing 3041–3050 of 8626 articles for “Art. 10 sept. 2020”
…of the pharmacovigilance data drawn up on the basis of the reports provided for in Article R. 5141-105; 2° Depending on the case, either an updated dossier taking account of the authorised changes, o…
I.- In the event of repackaging, the holder of a parallel import authorisation for a proprietary veterinary medicinal product shall notify the holder of the marketing authorisation for the proprietary…
The provisions relating to the import and export of veterinary medicinal products apply : 1° to medicinal products classified as narcotics or to which the narcotics regulations apply in whole or in pa…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may issue to veterinary pharmaceutical establishments exporting medicated feeding…
Autovaccines are prepared under the responsibility of a qualified person, who has obtained the authorisation provided for in article L. 5141-12, in facilities which may, where appropriate, be made ava…
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…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, at the request of a veterinary pharmaceutical establishment exporting a veterina…
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…
Within the meaning of article L. 5141-2, the veterinarian may only prescribe an auto-vaccine for veterinary use under the conditions of 4° of article L. 5143-4, prepared from a pathogen which he himse…
The holder of a parallel import authorisation for a proprietary veterinary medicinal product shall immediately inform the marketing authorisation holder in the country of origin of any serious adverse…
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