EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines 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 anddoes 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)

Paper Application Forms

Module 1.2 Application form (revision 10.1 - May 2013) 

Module 1.2 Homeopathic Application form (December 2005) 

 User guide for the application form (March 2005)

Variation

Renewal

Electronic Application Forms

 Volume 2C - Regulatory Guideline