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This Regulation sets out the requirements in terms of necessary data contents to be inserted into the official dossier for the authorization of veterinary medicinal products (also immunological veterinary medicinal products and pharmacopoeial veterinary medicinal products).
This text also prescribes that all homeopathic veterinary medicinal product authorizations or licenses shall be determined by a separate legislation.
This kind of request shall be granted by the Director General of the National Veterinary Service.
The Annex is part of this publication (technical issues and list of all necessary documents and data).
This Regulation sets out the requirements in terms of necessary data contents to be inserted into the official dossier for the authorization of veterinary medicinal products (also immunological veterinary medicinal products and pharmacopoeial veterinary medicinal products).
Titre:
Regulation No 60 of 9 May 2006 on the data requirements contained in the documentation for the authorization of veterinary medicinal products.
Pays:
Bulgarie
Type of document:
Règlement
Données de base:
Fichiers:
Date of text: