EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use

Volume 2 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 (SmPC), package information and classification for the supply, readability of the label and package leaflet requirements.

The Notice to Applicants below has been prepared by the European Commission, in consultation with the competent authorities of the Member States and the European Medicines Agency (EMA) . 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 Union Directives and Regulations.

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

Volume 2A - 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 2B - Presentation and content of the dossier

Notice to Applicants, Volume 2Bpdf(2 MB) incorporating the Common Technical Document (CTD) (May 2008).

Electronic Application Forms

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.

Content and requirements of application forms

From 1 January 2016 the paper (Word) application forms are not to be used for submissions anymore. They are available in PDF only for information concerning the content and requirements of the application forms.

Module 1.2 Application form (revision 12 - September 2015)


  • Application form for variation to a marketing authorisation for medicinal products (human and veterinary) to be used in the mutual recognition and the centralised procedure (June 2015) - PDF versionpdf(511 KB)


Homeopathic Application Form

Paper (Word) application form is still available and can be used for submissions for homeopathic medicinal products.

Module 1.2 Homeopathic Application form (December 2005)

Volume 2C - Regulatory Guideline