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Showing 551–560 of 68114 articles for “Art. s. R 225-136-1 and R 123-107”
Silence on the part of the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail shall constitute refusal of authorisation on expiry of a p…
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…
Except where human or animal health grounds preclude it, parallel import authorisation is granted if the following conditions are met:1° The veterinary medicinal product is obtained from a company aut…
Where, following the establishment of a new Community herbal monograph, the revision of an existing monograph or the revision of the list drawn up by the European Commission in application of Article…
Following the establishment of a new Community herbal monograph or the revision of an existing monograph, the registration holder shall submit a request for amendment of the registration dossier to th…
The detailed summaries of the tests accompanying the application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentione…
The application for authorisation to import a proprietary veterinary medicinal product in parallel is accompanied by a dossier comprising :1° For each presentation, a sample of the proprietary medicin…
I.-The registration of the medicinal products mentioned in article L. 5121-13 may be refused, amended, suspended or withdrawn by the Director General of the Agency. The period of suspension may not ex…
I.-The request for an import authorisation sent to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail must indicate : 1° The name or…
When the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail notifies the holder of the parallel import authorisation for a proprietary v…
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