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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

  • Chapter 1 - Marketing authorisations (August 2019)
  • Chaper 2 – Mutual recognition (deleted - August 2018)
    A dedicated chapter on the Mutual Recognition and Decentralised Procedure is no longer included in the NTA. The CMDv provides relevant information and guidance for companies and individuals regarding the Mutual Recognition and Decentralised Procedures. General Information on Mutual Recognition and Decentralised Procedure relating to former Chapter 2 of the Notice to Applicants as well as details of the procedures can be found on the CMDv website.
  • Chapter 3 - Union Referral Procedures (June 2018)
  • Chapter 4 - Centralised procedure (deleted - May 2016)
    The European Medicines Agency is responsible for the scientific evaluation of applications for European Union (EU) marketing authorisations for human and veterinary medicines in the centralised procedure. As the Agency provides relevant information and guidance for companies and individuals involved in developing and marketing medicines for veterinary use in the Union a dedicated chapter on the centralised procedure is no longer included in the NTA.
  • Chapter 5 - Guidelines of 16 May 2013 on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures - C (2013) 2804 (OJ C 223, 2.8.2013, p. 1–79)

  • Chapter 6 - Community marketing authorisation (November 2005)

    Please also note the notice of 12/10/2009:

    "Droit de regard" : Important notice to stakeholders - follow-up to the notice of 29/07/09

    Following an agreement with the responsible Committee in the European Parliament and in accordance with the interinstitutional agreement of 3 June 2008, the period of the "droit de regard" for the Commission Decisions taken as part of the "Decision making process" is shortened on a permanent basis to 7 days. This applies also in the recess periods of European Parliament.

    The shortened period of the "droit de regard" does, however, not apply in the following cases:

    • the draft Commission Decision is not in accordance with the scientific opinion of the EMA;
    • Member States, during the vote, request that the draft Decision is discussed in a plenary meeting of the Standing Committee; or
    • the opinion of the Standing Committee is unfavourable.

    The "Notice to applicants", Chapter VI, is going to be updated to this effect.

    This arrangement applies with immediate effect, i.e.:

    • Procedures in the Comitology phase which have been in the "droit de regard" stage for more than 7 days are going to be moved into the adoption phase (15 calendar days);
    • Procedures in the Comitology phase which are still in the voting phase of Member States will be subject to a shortened period of "droit de regard" of 7 days.

    In practice, the additional 7 days of the "droit de regard" following the vote by Member States will be used to prepare the final Decision for adoption once the 7 days have expired. Therefore, in practice, the timelines will not be much affected by the "droit de regard".

    Companies are kindly requested to refrain from ringing up the Commission staff to "urge" a faster processing of the draft Decision of "their" products.

  • Chapter 7 - General Information
    Information regarding veterinary medicinal products authorised centrally and nationally (Mutual Recognition Procedure/Decentralised Procedure) contained in this Chapter is transferred to EMA and CMDv websites, respectively. An overview of documents replacing the previous sections of Chapter 7 with corresponding website references is available at the following addresses:

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 6B gives 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.

  • eSubmission : EU Electronic Application Forms (Module 1.2 application, variation and renewal forms)
  • 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 EudraLex - 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