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

Therefore any reference to chapter 7 should be understood as reference to these webpages. However, guidelines and other interpretative documents to which references may be provided represent the views of their authors. 

Volume 6B - Presentation and content of the dossier

  • Notice to Applicants, Volume 6Bpdf(2 MB)
    Volume 6B Notice to applicants Veterinary medicinal products Presentation and contents of the dossier gives to guidance to applicants for marketing authorisations for veterinary medicinal products on the presentation of the data requirements and summaries of the dossier.
  • Paper Application Form
    Update June 2015 : The use of the electronic Application Forms (eAF) is mandatory for Centralised procedure from 1 July 2015. The eAFs must be used for all applications : authorisations, variations and renewals. The eAFs are available from http://esubmission.ema.europa.eu/eaf/index.html

PART I - Summary of the dossier / Administrative data

 Volume 6C - Regulatory Guidelines

Guidelines on Summary of product Characteristics

 Volume 6 - Electronic Submission

Update June 2015 : The use of the electronic Application Forms (eAF) is mandatory for Centralised procedure from 1 July 2015. The eAFs must be used for all applications : authorisations, variations and renewals.

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