Product information: Regulatory and procedural guidance

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Table of contents

General

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Document(s) Language Status First published Last updated Effective Date
Overview of comments received on draft revision 2 of the SmPC guideline - Proposal for a revision of the European Commission guideline on summary of product characteristics (English only)   22/10/2009    
Excipients in the label and package leaflet of medicinal products for human use ES = español adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use CS = čeština adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use DA = dansk adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use DE = Deutsch adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use ET = eesti keel adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use EL = elliniká adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use EN = English adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use FR = français adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use IT = italiano adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use LV = latviešu valoda adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use LT = lietuvių kalba adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use HU = magyar adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use MT = Malti adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use NL = Nederlands adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use PL = polski adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use PT = português adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use SK = slovenčina adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use SL = slovenščina adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use FI = suomi adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use SV = svenska adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use HR = Hrvatski adopted 01/07/2003    
Operational procedure on handling of consultation with target patient groups on package leaflets (PL) for centrally authorised products for human use (English only)   20/10/2005    
Quality Review of Documents Working Group plenary and sub-group meeting dates - Year 2012 (English only)   18/11/2009 07/03/2012  
Practical guidance on the extension of Commission Decision Annexes in the new accession country language (English only) adopted 31/01/2011    

QRD Templates

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Document(s) Language Status First published Last updated Effective Date
Quality Review of Documents human product-information annotated template (English) version 8 (English only)   03/12/1997 28/11/2011  
Quality Review of Documents human product-information template version 8 BG = bălgarski   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 ES = español   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 CS = čeština   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 DA = dansk   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 DE = Deutsch   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 ET = eesti keel   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 EL = elliniká   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 EN = English   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 FR = français   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 IT = italiano   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 LV = latviešu valoda   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 LT = lietuvių kalba   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 HU = magyar   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 MT = Malti   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 NL = Nederlands   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 PL = polski   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 PT = português   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 RO = română   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 SK = slovenčina   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 SL = slovenščina   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 FI = suomi   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 SV = svenska   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 IS = Islenska   03/12/1997 12/10/2011  
Quality Review of Documents human product-information template version 8 NO = Norsk   03/12/1997 12/10/2011  
Quality Review of Documents human Annex A template BG = bălgarski   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template ES = español   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template CS = čeština   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template DA = dansk   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template DE = Deutsch   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template ET = eesti keel   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template EL = elliniká   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template EN = English   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template FR = français   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template IT = italiano   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template LV = latviešu valoda   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template LT = lietuvių kalba   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template HU = magyar   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template MT = Malti   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template NL = Nederlands   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template PL = polski   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template PT = português   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template RO = română   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template SK = slovenčina   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template SL = slovenščina   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template FI = suomi   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template SV = svenska   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template IS = Islenska   19/06/2009 08/05/2012  
Quality Review of Documents human Annex A template NO = Norsk   19/06/2009 08/05/2012  
Implementation plan (English only)   08/10/2009 22/07/2011  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics BG = bălgarski   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics ES = español   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics CS = čeština   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics DA = dansk   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics DE = Deutsch   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics ET = eesti keel   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics EL = elliniká   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics EN = English   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics FR = français   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics IT = italiano   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics LV = latviešu valoda   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics LT = lietuvių kalba   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics HU = magyar   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics MT = Malti   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics NL = Nederlands   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics PL = polski   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics PT = português   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics RO = română   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics SK = slovenčina   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics SL = slovenščina   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics FI = suomi   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics SV = svenska   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics IS = Islenska   01/07/2008 04/11/2009  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics NO = Norsk   01/07/2008 04/11/2009  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics BG = bălgarski   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics ES = español   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics CS = čeština   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics DA = dansk   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics DE = Deutsch   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics ET = eesti keel   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics EL = elliniká   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics EN = English   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics FR = français   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics IT = italiano   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics LV = latviešu valoda   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics LT = lietuvių kalba   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics HU = magyar   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics MT = Malti   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics NL = Nederlands   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics PL = polski   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics PT = português   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics RO = română   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics SK = slovenčina   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics SL = slovenščina   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics FI = suomi   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics SV = svenska   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics IS = Islenska   01/07/2009 09/02/2010  
Appendix II - Medical Dictionary for Regulatory Activities (version 12.0) terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics NO = Norsk   01/07/2009 09/02/2010  
Guideline on declaration of storage conditions (English only) adopted 19/11/2007   01/10/2003
Appendix III to the Quality Review of Documents templates for human medicinal products BG = bălgarski   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products ES = español   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products CS = čeština   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products DA = dansk   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products DE = Deutsch   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products ET = eesti keel   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products EL = elliniká   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products EN = English   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products FR = français   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products IT = italiano   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products LV = latviešu valoda   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products LT = lietuvių kalba   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products HU = magyar   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products MT = Malti   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products NL = Nederlands   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products PL = polski   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products PT = português   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products RO = română   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products SK = slovenčina   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products SL = slovenščina   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products FI = suomi   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products SV = svenska   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products IS = Islenska   31/07/2008    
Appendix III to the Quality Review of Documents templates for human medicinal products NO = Norsk   31/07/2008    
Appendix IV - Terms for batch number and expiry date to be used on outer and/or inner labelling (English only)   01/07/2008 10/05/2012  
Quality Review of Documents Annex I template for referrals BG = bălgarski   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals ES = español   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals CS = čeština   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals DA = dansk   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals DE = Deutsch   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals ET = eesti keel   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals EL = elliniká   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals EN = English   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals FR = français   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals IT = italiano   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals LV = latviešu valoda   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals LT = lietuvių kalba   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals HU = magyar   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals MT = Malti   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals NL = Nederlands   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals PL = polski   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals PT = português   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals RO = română   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals SK = slovenčina   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals SL = slovenščina   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals FI = suomi   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals SV = svenska   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals IS = Islenska   19/06/2009 30/08/2011  
Quality Review of Documents Annex I template for referrals NO = Norsk   19/06/2009 30/08/2011  
Guidance on templates for referral procedures (English only)   08/12/2005 30/08/2011  

QRD Review

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Document(s) Language Status First published Last updated Effective Date
The linguistic review process of product information in the centralised procedure - Human (English only)   15/10/2008 07/02/2011  
Procedure for review of information on medicinal products by patients' and consumers' organisations (English only)   24/11/2008 11/05/2010  
Notification of a change for parallel distribution of a centrally authorised medicinal product (English only)   06/04/2008 10/11/2010  
QRD Form 1: For member states product information check - Day 229 (English only)   19/06/2009 06/05/2010  
QRD Form 2: For applicants when submitting revised translations to the European Medicines Agency - Day 235 / Day + 25 (English only)   19/06/2009 03/05/2010  
Member States' contact points for translation review (English only)   21/04/2009 03/05/2012  
Standard operating procedure for PIQ/QRD pre-opinion review of product information for initial applications and Annex II applications (English only) adopted 08/04/2009 15/12/2010 15/12/2010
Standard operating procedure for PIQ/QRD pre-opinion review of product information for renewal procedures (English only) adopted 30/04/2008 15/12/2010 15/12/2010
Standard operating procedure for QRD post-opinion review of product information for initial applications and Annex II applications (English only) adopted 08/04/2009 15/12/2010 15/12/2010
Standard operating procedure for QRD post-opinion review of product information for post-authorisation procedures affecting the annexes, excluding Annex II applications (English only) adopted 08/04/2009 15/12/2010 15/12/2010
Standard operating procedure for handling of financial compensation for checking of product information by the Member States (English only) adopted 25/04/2008 20/12/2010 17/12/2010
User guide on how to generate PDF versions of the Product Information (English only)   21/04/2009 18/05/2011  
Formatting check list for the product information (Annexes) in PDF format (English only)   21/04/2009 18/05/2011  

QRD Guidance

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Document(s) Language Status First published Last updated Effective Date
List of official languages per country (English only)   04/04/2012    
Abbreviation of names of days on calendarised blisters (English only)   04/04/2012    
Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates (English only) adopted 01/06/2007 15/04/2011 01/06/2007
Draft Quality Review of Documents recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products (English only) draft: consultation closed 01/04/2011    
Compilation of QRD decisions on stylistic matters in product information (English only)   01/02/2008 03/10/2011  
Compilation of QRD decisions on the use of terms (English only)   01/12/2005 28/03/2011  
Tables of non-standard abbreviations to be used in SmPC (English only)   01/04/2009 27/01/2011  
Addressing the paediatric or incapacitated patient in the package leaflet (English only)   09/03/2000    
Names of the EU / EEA countries (English only)   23/07/2008 27/01/2011  
QRD recommendations on the expression of strength in the name of centrally authorised human medicinal products (as stated in section 1 of SmPC, and in the name section of labelling and PL) (English only) adopted 18/11/2009   01/03/2010

Mock-ups and Specimens

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Document(s) Language Status First published Last updated Effective Date
The revised checking process of mock-ups and specimens of outer/immediate labelling and package leaflets of human medicinal products in the centralised procedure (English only)   22/01/2007    
Specimen submission form (English only)   24/11/2008    
Standard operating procedure for checking of mock-ups and specimens for new applications and extensions (English only) adopted 21/10/2008 20/12/2010 17/12/2010
Standard Operating Procedure for Checking of Mock-ups and Specimens for Renewals (English only) adopted 10/06/2008 20/12/2010 17/12/2010
Standard Operating Procedure for Checking of Mock-ups and Specimens for Transfer of Marketing Authorisation (English only) adopted 10/06/2008 20/12/2010 17/12/2010
Standard Operating Procedure for Checking of Mock-ups and Specimens for All Post-Authorisation Procedures other than New Applications, Line Extensions, Renewals and Transfers (English only) adopted 10/06/2008 20/12/2010 17/12/2010

PIM

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