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Qdossier Qsauri
"F"

full application (article 12(3) of directive no 2001/82/EC)
Guideline or reference source
SPOR Referentials Management System of European Medicines Agency
Definition
Article 12(3) application, (i.e. dossier with administrative, quality, safety and efficacy data*) for veterinary use.
Broader Term
application legal basis
 

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