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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
- Chapter 1 - Marketing Authorisation (updated version - June 2013)
- Chapter 2 - Mutual Recognition (updated version - February 2007)
- Chapter 3 - Community Referral (updated version - September 2007)
- Chapter 4 - Centralised Procedure (updated version - April 2006)
- 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 (updated version - November 2005)
Please also note the notice of 12/10/2009 here.
- Chapter 7 - General Information
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.
- For CMDh, see document titled: "Transfer of information contained in Notice to applicants, Volume 2A, Chapter 7"
- For EMA:
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.
Notice to Applicants, Volume 2B
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)
- 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. (July 2013)
- Application form for renewal of a marketing authorisation (July 2013)
Electronic Application Forms
- eSubmission : EU Electronic Application Forms (Module 1.2 application, variation and renewal forms)
- Questions and Answers (February 2008)
- Electronic Common Technical Document (eCTD)
- Change Control Process for European eCTD Standards
- Guidance on a new therapeutic indication for a well established substance (November 2007)
- Guidance on elements required to support the significant benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period (November 2007)
- Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) (October 2003)
- Guideline on the processing of renewals:
- Guideline on Summary of Product Characteristics - SmPC (September 2009)
- Guideline on changing the classification for the supply of a medicinal product for human use
- Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2013)
- Guideline on the readability of the labeling and package leaflet of medicinal product for human use, revision 1 (12 January 2009)
- Guideline on Vaccine Antigen Master File/ Plasma Master File (VAMF/PMF) (August 2004):
- 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 (OJ C 133, 8/6/2006 p. 5 - 7) 2006/C 133/05
- Annex Examples of issues which normally would not be considered as grounds for a ‘Potential Serious Risk to Public Health’1 in accordance with specific requirements according to Directive 2001/83/EC as amended.