EudraLex - Volume 6 Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use

Volume 6 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SPC), package information and classification for the supply, readability of the label and package leaflet requirements.
This Notice to Applicants has been prepared by the European Commission, in consultation with the competent authorities of the Member States and the European Medicines Agency. This Notice has no legal force and does not necessarily represent the final views of the Commission. In case of doubt, therefore, reference should be made to the appropriate Community Directives and Regulations.

The Notice to Applicants was first published in 1986 and is regularly updated.

Volume 6A - Procedures for marketing authorisation

Volume 6B - Presentation and content of the dossier

Volume 6B Notice to applicants Veterinary medicinal products pdf(540 KB) (March 2004)

Volume 6B Notice to applicants Veterinary medicinal products Presentation and contents of the dossier pdf(251 KB)(January 2014)
Volume 6B gives to guidance to applicants for marketing authorisations for veterinary medicinal products on the presentation of the data requirements and summaries of the dossier.
(PDF formatpdf(251 KB)) - (Word Formatmsw8(408 KB))

PART I - Summary of the dossier / Administrative data

1A - Revision 7.2 - 0ctober 2008 ( PDF format of 1A - Revision 7.2pdf(174 KB) - Word format of 1A - Revision 7.2msw8(479 KB) )

 Volume 6C - Regulatory Guidelines

Guidelines on Summary of product Characteristics

 Volume 6 - Electronic Submission

For further information, see volume 2B - (Human)