EudraLex - Volume 2 - Pharmaceutical Legislation
Notice to applicants and regulatory guidelines medicinal products for human use
On this page :
Volume 2A dealing with procedures for marketing authorisation;
Volume 2B dealing with the presentation and content of the application dossier.
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 (SPC), 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. 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.
Volume 2A - Procedures for marketing authorisation
Chapter 1 - Marketing Authorisation (updated version - November 2005
Chapter 2 - Mutual Recognition - updated version - February 2007
Chapter 3 - Community Referral - updated version - Pdf Version - Word Version - September 2007
Chapter 4 - Centralised Procedure (updated version - Avril 2006
Chapter 5 - Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 as well as on the documentation to be submitted pursuant to these procedures. - February 2010
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Chapter 6 - Community Marketing Authorisation - November 2005
Chapter 7 - General Information
For EMA: Pre-submission (external link) - Post-authorisation (external link
For CMDh, see document titled: "Transfer of information contained in Notice to applicants, Volume 2A, Chapter 7" (external link)
Information regarding human medicinal products authorised centrally and nationally (Mutual Recognition Procedure/DeCentralised Procedure) contained in this Chapter is transferred to EMA and CMDh websites respectively. An overview of documents replacing the previous sections of Chapter 7 with corresponding website references is available at the following address.
Volume 2B - Presentation and content of the dossier
Notice to Applicants, Volume 2B, incorporating the Common Technical Document (CTD)
- May 2008
Application Form : Module 1.2 Application form - updated version, revision 9 - May 2008
- Module 1.2 Application form - pdf document - May 2008
- Module 1.2 Application form - word document - May 2008
- Module 1.2 Homeopathic application form -.pdf document - December 2005
- Module 1.2 Homeopathic application form - word document - December 2005
- User guide for the application form - March 2005
Notice to Applicants, Volume 2B - QUESTIONS and ANSWERS
- Questions and Answers - February 2008
Notice to Applicants, Volume 2B - Electronic Common Technical Document (eCTD)
- eCTD EU Module 1 ( version 1.4.1 - November 2011) - zip file (for download only right click and Save Target As...)
- eCTD EU Module 1 version 1.4 Implementation Guidance - August 2009
- eCTD MRP/DCP Tracking Table (v1.0, May 2008) - zip file (This new standard can be used to track eCTD submissions to National Competent Authorities in MRP/DCP - for download only right click and Save Target As...)
- Electronic Application Forms (New -Variation - Renewal) (external link)
- Guidance on paper submission with eCTD (version 2 March 2010)
Notice to Applicants, Volume 2B - Change Control Process for European eCTD Standarts
- Change Control Process for European eCTD Standards (version 2.1 May 2011)
- Change Control Form (version 2.1 May 2011).
Volume 2C - Regulatory Guidelines
- Guidance on a new therapeutic indication for a well established substance - November 2007
- Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) - October 2003
- Guideline on the processing of renewals in the centralised procedure - June 2012
- Guideline on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures - Revision 4, February 2008
- Application form for renewal of a marketing authorisation - October 2012
PDF format of the application form - Word format of the application form
- Guideline on fast track procedure for human influenza vaccines - May 1999
- Guideline on Summary of Product Characteristics - SmPC - September 2009
Word format en [2 MB]
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- Guideline on Dossier requirements for Type IA and Type IB Notifications - PDF Format - Word format Revision 1 July 2006
- 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 (December 2009).
Application Form : PDF format - Word format - December 2009
- Guideline on the packaging information of medicinal products for human use authorised by the Community - February 2008
- Guideline on changing the classification for the supply of a medicinal product for human use - January 2006
- Guideline on the readability of the labeling and package leaflet of medicinal product for human use - revision 1, January 2009
- Guidance concerning consultation with target patient groups for the package leaflet
Guideline on Vaccine Antigen Master File/ Plasma Master File (VAMF/PMF) - August 2004
- the guideline on the procedure for VAMF certification
- the guideline on the procedure for PMF certification
- the guideline on the “2nd step”, when the Competent Authority has to take into account the effect of the PMF/VAMF certification on the concerned medicinal product(s).
2006/C 133/05
Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC (Official Journal C 133, 8/6/2006 p. 5 - 7)
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