Product-information templates

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This page lists the templates for product information for use by applicants and marketing-authorisation holders. The European Medicines Agency's Working Group on Quality Review of Documents (QRD) develops, reviews and updates these templates.

Please note that:

  • the Agency does not publish English templates for the annex A and annex I for referrals, because these annexes are prepared by the Agency. The translations of these annexes must be in line and consistent with the adopted English product information annexes of the product concerned;
  • the information contained in these documents is non-exhaustive. Companies should refer to all relevant European Union legislation and guidelines when drawing up applications. It is the company’s responsibility to ensure that the product information complies with all such requirements;
  • Maltese fonts are built in to Windows XP SP3 and higher;
  • all Microsoft Office documents submitted to the European Medicines Agency must be in a format compatible with Microsoft Office 2003. Office 2007 and Office 2010 formats cannot currently be accepted.

Table of contents


Centralised procedures

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Document(s) Language Status First published Last updated Effective Date
Draft Quality Review of Documents human product information annotated template: revision of the product information (English only) draft: consultation closed 16/07/2012    
Quality Review of Documents human product-information annotated template (English) version 9 (English only)   03/12/1997 15/03/2013  
Quality Review of Documents human product-information annotated template (English) version 9 - highlighted (English only)   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 BG = bălgarski   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 ES = español   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 CS = čeština   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 DA = dansk   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 DE = Deutsch   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 ET = eesti keel   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 EL = elliniká   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 EN = English   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 FR = français   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 IT = italiano   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 LV = latviešu valoda   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 LT = lietuvių kalba   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 HU = magyar   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 MT = Malti   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 NL = Nederlands   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 PL = polski   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 PT = português   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 RO = română   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 SK = slovenčina   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 SL = slovenščina   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 FI = suomi   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 SV = svenska   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 HR = Hrvatski   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 IS = Islenska   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 NO = Norsk   03/12/1997 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted BG = bălgarski   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted ES = español   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted CS = čeština   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted DA = dansk   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted DE = Deutsch   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted ET = eesti keel   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted EL = elliniká   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted EN = English   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted FR = français   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted IT = italiano   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted LV = latviešu valoda   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted LT = lietuvių kalba   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted HU = magyar   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted MT = Malti   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted NL = Nederlands   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted PL = polski   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted PT = português   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted RO = română   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted SK = slovenčina   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted SL = slovenščina   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted FI = suomi   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted SV = svenska   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted HR = Hrvatski   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted IS = Islenska   22/07/2011 15/03/2013  
Quality Review of Documents human product-information template version 9 - highlighted NO = Norsk   22/07/2011 15/03/2013  
Quality Review of Documents human annex-A template BG = bălgarski   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template ES = español   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template CS = čeština   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template DA = dansk   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template DE = Deutsch   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template ET = eesti keel   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template EL = elliniká   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template EN = English   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template FR = français   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template IT = italiano   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template LV = latviešu valoda   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template LT = lietuvių kalba   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template HU = magyar   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template MT = Malti   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template NL = Nederlands   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template PL = polski   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template PT = português   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template RO = română   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template SK = slovenčina   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template SL = slovenščina   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template FI = suomi   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template SV = svenska   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template HR = Hrvatski   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template IS = Islenska   19/06/2009 15/06/2012  
Quality Review of Documents human annex-A template NO = Norsk   19/06/2009 15/06/2012  
Quality Review of Documents human annex related to the Article-127a template BG = bălgarski   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template ES = español   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template CS = čeština   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template DA = dansk   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template DE = Deutsch   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template ET = eesti keel   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template EL = elliniká   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template EN = English   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template FR = français   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template IT = italiano   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template LV = latviešu valoda   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template LT = lietuvių kalba   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template HU = magyar   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template MT = Malti   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template NL = Nederlands   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template PL = polski   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template PT = português   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template RO = română   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template SK = slovenčina   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template SL = slovenščina   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template FI = suomi   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template SV = svenska   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template HR = Hrvatski   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template IS = Islenska   08/10/2012    
Quality Review of Documents human annex related to the Article-127a template NO = Norsk   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template BG = bălgarski   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template ES = español   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template CS = čeština   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template DA = dansk   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template DE = Deutsch   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template ET = eesti keel   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template EL = elliniká   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template EN = English   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template FR = français   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template IT = italiano   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template LV = latviešu valoda   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template LT = lietuvių kalba   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template HU = magyar   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template MT = Malti   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template NL = Nederlands   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template PL = polski   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template PT = português   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template RO = română   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template SK = slovenčina   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template SL = slovenščina   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template FI = suomi   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template SV = svenska   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template HR = Hrvatski   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template IS = Islenska   08/10/2012    
Quality Review of Documents human annex-IV conditional positive template NO = Norsk   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template BG = bălgarski   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template ES = español   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template CS = čeština   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template DA = dansk   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template DE = Deutsch   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template ET = eesti keel   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template EL = elliniká   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template EN = English   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template FR = français   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template IT = italiano   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template LV = latviešu valoda   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template LT = lietuvių kalba   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template HU = magyar   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template MT = Malti   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template NL = Nederlands   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template PL = polski   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template PT = português   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template RO = română   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template SK = slovenčina   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template SL = slovenščina   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template FI = suomi   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template SV = svenska   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template HR = Hrvatski   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template IS = Islenska   08/10/2012    
Quality Review of Documents human Annex IV exceptional circumstances positive template NO = Norsk   08/10/2012    
Quality Review of Documents human annex-IV standard positive template BG = bălgarski   08/10/2012    
Quality Review of Documents human annex-IV standard positive template ES = español   08/10/2012    
Quality Review of Documents human annex-IV standard positive template CS = čeština   08/10/2012    
Quality Review of Documents human annex-IV standard positive template DA = dansk   08/10/2012    
Quality Review of Documents human annex-IV standard positive template DE = Deutsch   08/10/2012    
Quality Review of Documents human annex-IV standard positive template ET = eesti keel   08/10/2012    
Quality Review of Documents human annex-IV standard positive template EL = elliniká   08/10/2012    
Quality Review of Documents human annex-IV standard positive template EN = English   08/10/2012    
Quality Review of Documents human annex-IV standard positive template FR = français   08/10/2012    
Quality Review of Documents human annex-IV standard positive template IT = italiano   08/10/2012    
Quality Review of Documents human annex-IV standard positive template LV = latviešu valoda   08/10/2012    
Quality Review of Documents human annex-IV standard positive template LT = lietuvių kalba   08/10/2012    
Quality Review of Documents human annex-IV standard positive template HU = magyar   08/10/2012    
Quality Review of Documents human annex-IV standard positive template MT = Malti   08/10/2012    
Quality Review of Documents human annex-IV standard positive template NL = Nederlands   08/10/2012    
Quality Review of Documents human annex-IV standard positive template PL = polski   08/10/2012    
Quality Review of Documents human annex-IV standard positive template PT = português   08/10/2012    
Quality Review of Documents human annex-IV standard positive template RO = română   08/10/2012    
Quality Review of Documents human annex-IV standard positive template SK = slovenčina   08/10/2012    
Quality Review of Documents human annex-IV standard positive template SL = slovenščina   08/10/2012    
Quality Review of Documents human annex-IV standard positive template FI = suomi   08/10/2012    
Quality Review of Documents human annex-IV standard positive template SV = svenska   08/10/2012    
Quality Review of Documents human annex-IV standard positive template HR = Hrvatski   08/10/2012    
Quality Review of Documents human annex-IV standard positive template IS = Islenska   08/10/2012    
Quality Review of Documents human annex-IV standard positive template NO = Norsk   08/10/2012    
Quality Review of Documents human PSUR Annex IV template BG = bălgarski   19/03/2014    
Quality Review of Documents human PSUR Annex IV template ES = español   19/03/2014    
Quality Review of Documents human PSUR Annex IV template CS = čeština   19/03/2014    
Quality Review of Documents human PSUR Annex IV template DA = dansk   19/03/2014    
Quality Review of Documents human PSUR Annex IV template DE = Deutsch   19/03/2014    
Quality Review of Documents human PSUR Annex IV template ET = eesti keel   19/03/2014    
Quality Review of Documents human PSUR Annex IV template EL = elliniká   19/03/2014    
Quality Review of Documents human PSUR Annex IV template EN = English   19/03/2014    
Quality Review of Documents human PSUR Annex IV template FR = français   19/03/2014    
Quality Review of Documents human PSUR Annex IV template IT = italiano   19/03/2014    
Quality Review of Documents human PSUR Annex IV template LV = latviešu valoda   19/03/2014    
Quality Review of Documents human PSUR Annex IV template LT = lietuvių kalba   19/03/2014    
Quality Review of Documents human PSUR Annex IV template HU = magyar   19/03/2014    
Quality Review of Documents human PSUR Annex IV template MT = Malti   19/03/2014    
Quality Review of Documents human PSUR Annex IV template NL = Nederlands   19/03/2014    
Quality Review of Documents human PSUR Annex IV template PL = polski   19/03/2014    
Quality Review of Documents human PSUR Annex IV template PT = português   19/03/2014    
Quality Review of Documents human PSUR Annex IV template RO = română   19/03/2014    
Quality Review of Documents human PSUR Annex IV template SK = slovenčina   19/03/2014    
Quality Review of Documents human PSUR Annex IV template SL = slovenščina   19/03/2014    
Quality Review of Documents human PSUR Annex IV template FI = suomi   19/03/2014    
Quality Review of Documents human PSUR Annex IV template SV = svenska   19/03/2014    
Quality Review of Documents human PSUR Annex IV template HR = Hrvatski   19/03/2014    
Quality Review of Documents human PSUR Annex IV template IS = Islenska   19/03/2014    
Quality Review of Documents human PSUR Annex IV template NO = Norsk   19/03/2014    
Implementation plan for the introduction of the new pharmacovigilance legislation requirements into the product information of centrally approved medicinal products (English only)   08/10/2009 15/03/2013  
Implementation plan for the update to annex II of the Quality Review of Documents template for centrally authorised products (English only)   13/11/2012 11/02/2013  
Quality Review of Documents human product-information template version 8.3 BG = bălgarski   18/03/2013    
Quality Review of Documents human product-information template version 8.3 ES = español   18/03/2013    
Quality Review of Documents human product-information template version 8.3 CS = čeština   18/03/2013    
Quality Review of Documents human product-information template version 8.3 DA = dansk   18/03/2013    
Quality Review of Documents human product-information template version 8.3 DE = Deutsch   18/03/2013    
Quality Review of Documents human product-information template version 8.3 ET = eesti keel   18/03/2013    
Quality Review of Documents human product-information template version 8.3 EL = elliniká   18/03/2013    
Quality Review of Documents human product-information template version 8.3 EN = English   18/03/2013    
Quality Review of Documents human product-information template version 8.3 FR = français   18/03/2013    
Quality Review of Documents human product-information template version 8.3 IT = italiano   18/03/2013    
Quality Review of Documents human product-information template version 8.3 LV = latviešu valoda   18/03/2013    
Quality Review of Documents human product-information template version 8.3 LT = lietuvių kalba   18/03/2013    
Quality Review of Documents human product-information template version 8.3 HU = magyar   18/03/2013    
Quality Review of Documents human product-information template version 8.3 MT = Malti   18/03/2013    
Quality Review of Documents human product-information template version 8.3 NL = Nederlands   18/03/2013    
Quality Review of Documents human product-information template version 8.3 PL = polski   18/03/2013    
Quality Review of Documents human product-information template version 8.3 PT = português   18/03/2013    
Quality Review of Documents human product-information template version 8.3 RO = română   18/03/2013    
Quality Review of Documents human product-information template version 8.3 SK = slovenčina   18/03/2013    
Quality Review of Documents human product-information template version 8.3 SL = slovenščina   18/03/2013    
Quality Review of Documents human product-information template version 8.3 FI = suomi   18/03/2013    
Quality Review of Documents human product-information template version 8.3 SV = svenska   18/03/2013    
Quality Review of Documents human product-information template version 8.3 HR = Hrvatski   18/03/2013    
Quality Review of Documents human product-information template version 8.3 IS = Islenska   18/03/2013    
Quality Review of Documents human product-information template version 8.3 NO = Norsk   18/03/2013    

Mutual-recognition, decentralised and referral procedures

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Document(s) Language Status First published Last updated Effective Date
Mutual-recognition, decentralised and referral product-information template version 3 BG = bălgarski   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 ES = español   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 CS = čeština   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 DA = dansk   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 DE = Deutsch   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 ET = eesti keel   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 EL = elliniká   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 EN = English   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 FR = français   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 IT = italiano   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 LV = latviešu valoda   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 LT = lietuvių kalba   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 HU = magyar   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 MT = Malti   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 NL = Nederlands   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 PL = polski   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 PT = português   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 RO = română   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 SK = slovenčina   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 SL = slovenščina   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 FI = suomi   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 SV = svenska   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 HR = Hrvatski   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 IS = Islenska   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 NO = Norsk   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) BG = bălgarski   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) ES = español   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) CS = čeština   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) DA = dansk   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) DE = Deutsch   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) ET = eesti keel   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) EL = elliniká   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) EN = English   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) FR = français   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) IT = italiano   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) LV = latviešu valoda   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) LT = lietuvių kalba   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) HU = magyar   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) MT = Malti   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) NL = Nederlands   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) PL = polski   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) PT = português   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) RO = română   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) SK = slovenčina   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) SL = slovenščina   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) FI = suomi   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) SV = svenska   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) HR = Hrvatski   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) IS = Islenska   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) NO = Norsk   01/10/2006 11/04/2013  
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 HR = Hrvatski   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  

Appendices

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Document(s) Language Status First published Last updated Effective Date
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 HR = Hrvatski   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 HR = Hrvatski   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  
Appendix III to the Quality Review of Documents templates for human medicinal products BG = bălgarski   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products ES = español   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products CS = čeština   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products DA = dansk   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products DE = Deutsch   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products ET = eesti keel   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products EL = elliniká   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products EN = English   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products FR = français   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products IT = italiano   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products LV = latviešu valoda   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products LT = lietuvių kalba   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products HU = magyar   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products MT = Malti   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products NL = Nederlands   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products PL = polski   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products PT = português   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products RO = română   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products SK = slovenčina   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products SL = slovenščina   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products FI = suomi   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products SV = svenska   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products HR = Hrvatski   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products IS = Islenska   31/07/2008 10/07/2012  
Appendix III to the Quality Review of Documents templates for human medicinal products NO = Norsk   31/07/2008 10/07/2012  
Appendix IV - Terms for batch number and expiry date to be used on outer and / or inner labelling (English only)   01/07/2008 18/11/2013  
Appendix V - Adverse-drug-reaction reporting details (English only)   15/03/2013 14/04/2014