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 (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 (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 Community 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 - November 2005)(169 KB)
• Chapter 2 - Mutual Recognition (updated version - February 2007)(526 KB)
• Chapter 3 - Community Referral (updated version - September 2007) - PDF Version of Chapter 3(117 KB) - Word Version of Chapter 3(211 KB)
• Chapter 4 - Centralised Procedure (updated version - Avril 2006)(162 KB)
• 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)(805 KB)  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)  
  • Procedural note (9 KB)concerning the application of articles 28(3), 36 and 37 of regulation 1901/2006 (August 2012)
  • Procedural note(9 KB) concerning  the Guideline on the operation of the procedures laid down in chapters II, III, and IV of commission regulation (ec) 1234/2008 of concerning the examination of variations to the Terms of Marketing Authorisations for Medicinal Products for human use and veterinary medicinal products (March 2011)
• Chapter 6 - Community Marketing Authorisation (updated version - November 2005)(91 KB)
  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:
    • Pre-submission:
      http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000157.jsp&mid=WC0b01ac058002251f
    •  Post-authorisation:
      http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000166.jsp&mid=WC0b01ac0580023399

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 2B(2 MB), incorporating the Common Technical Document (CTD) (May 2008)(2 MB)

Application Form : Module 1.2 Application form

• Module 1.2 Application form (revision 10.1) - pdf document (May 2013)(353 KB)
• Module 1.2 Application form (revision 10.1) - word document (May 2013)(428 KB)
• Electronic Application Forms (external link >>)
• Module 1.2 Homeopathic application form - pdf document (December 2005)(82 KB)
• Module 1.2 Homeopathic application form - word document (December 2005)(239 KB)
• User guide for the application form (March 2005)(53 KB)

Notice to Applicants, Volume 2B - QUESTIONS and ANSWERS

• Questions and Answers (February 2008)(51 KB)

Notice to Applicants, Volume 2B - Electronic Common Technical Document (eCTD)

• EU Module 1 Specification Version 1.4.1 - November 2011(646 KB) - zip file (for download only right click and Save Target As...)
• eCTD EU Module 1 version 1.4 Implementation Guidance (August 2009)(16 KB)
• eCTD MRP/DCP Tracking Table (v1.0, May 2008) - zip file(258 KB) (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...)
• Guidance on paper submission with eCTD (version 2.0 March 2010)(420 KB)

Notice to Applicants, Volume 2B - Change Control Process for European eCTD Standards

• Change Control Process for European eSubmission Standards - v2 1 (May 2011)(158 KB)
• Electronic Submission Change Request Q&A_Form - v2 1 (May 2011)(321 KB)

 Volume 2C - Regulatory Guidelines

• 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)(48 KB)
• Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) (October 2003)(300 KB)
• Guideline on the processing of renewals in the centralised procedure (June 2012) (220 KB)
• Guideline on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures (Revision 4, February 2008)(87 KB)
• Application form for renewal of a marketing authorisation (October 2012)
  PDF format of the application form (44 KB)- Word format of the application form(176 KB)
• Guideline on fast track procedure for human influenza vaccines(185 KB)
• Guideline on Summary of Product Characteristics - SmPC (September 2009)(142 KB)
• Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (2010/C 17/01)(2 MB)  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)  - Word format en(2 MB) (February 2010)
• 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. PDF format of the application form(142 KB) - Word format of the application form(2 MB). (December 2009)
• Guideline on the packaging information of medicinal products for human use authorised by the Community (February 2008)(279 KB)
• Guideline on changing the classification for the supply of a medicinal product for human use(45 KB)
• Guideline on the readability of the labeling and package leaflet of medicinal product for human use, revision 1 (12 January 2009)(119 KB)
• Guidance concerning consultation with target patient groups for the package leaflet(29 KB)
• Guideline on Vaccine Antigen Master File/ Plasma Master File (VAMF/PMF) (August 2004):
  • the guideline on the procedure for VAMF certification(251 KB)
  • the guideline on the procedure for PMF certification(218 KB)
  • 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)(41 KB)
• 2006/C 133/05(97 KB)  čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Nederlands (nl) polski (pl) português (pt) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)
  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)
  Annex(21 KB)

 

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