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.

Electronic Application Form

The use of the electronic Application Forms (eAF) is mandatory for all procedures from 1 January 2016. 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

  • User guide for the electronic application form
    • The User guide for the electronic application form is available on both CMDv website and eSubmission website.
      To be noted that this guide is not a NTA document anymore and hyperlinks are available on this page for information. Regular update of this common document (for centralised and decentralised applications) will be available directly on these websites.

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

Content and requirements of application form

From 1 January 2016 the paper (Word) application form is not to be used for submissions anymore. It is available in pdf only for information concerning the content and requirements of the application form.

Volume 6C - Regulatory Guidelines

Guidelines on Summary of product Characteristics