Product-information templates

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

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.

Latest update: correction of certain language versions in April 2016

Due to technical issues, certain language versions of the latest product information templates (version 10, published in February 2016) contained inaccuracies. The correct templates were re-published in April 2016 in the following languages: BG, DA, DE, EL, ES, ET, FR, HR, IT, MT, NL, PT, SK, SL and SV.

Maltese fonts

Maltese fonts are built in to Windows XP SP3 and higher.

Quick response (QR) codes

A request for the inclusion of Quick Response (QR) codes can be made in the context of an evaluation procedure (as part of the initial marketing-authorisation application or after the medicine is authorised via Article 61(3) with the rapporteur’s involvement or other procedure affecting annexes) by submitting the QR code request/declaration form along with all relevant information within module 1.3.1 of the dossier.

Guidance on submission requirements, general principles of acceptability and assessment of QR code requests is available in Quick Response (QR) codes in the labelling and package leaflet of centrally authorised medicinal products.

A list of national contact points has been set up for the review of national versions of QR codes approved through the centralised procedure.

Update: Information on doping

There is no direct legal requirement to include information on doping in sport in the product information of centrally authorised medicines. The Agency advises applicants not to include statements on doping.

However, the Agency acknowledges the public-health interest in accessing up-to-date information on substances that can be used in doping. This information is available on the website of the World Anti-Doping Agency (WADA), an independent international organisation created to promote, coordinate and monitor the fight against doping in sport in all its forms:

Table of contents


Centralised procedures

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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 10 (English only)   1997-12-03 2016-02-09  
Quality Review of Documents human product-information annotated template (English) version 10 - highlighted (English only)   1997-12-03 2016-02-09  
Quality Review of Documents human product-information template version 10 BG = bălgarski   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 ES = español   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 CS = čeština   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 DA = dansk   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 DE = Deutsch   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 ET = eesti keel   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 EL = elliniká   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 EN = English   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 FR = français   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 IT = italiano   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 LV = latviešu valoda   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 LT = lietuvių kalba   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 HU = magyar   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 MT = Malti   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 NL = Nederlands   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 PL = polski   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 PT = português   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 RO = română   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 SK = slovenčina   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 SL = slovenščina   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 FI = suomi   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 SV = svenska   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 HR = Hrvatski   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 IS = Islenska   1997-12-03 2016-04-22  
Quality Review of Documents human product-information template version 10 NO = Norsk   1997-12-03 2016-04-22  
Quality Review of Documents human annex-A template BG = bălgarski   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template ES = español   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template CS = čeština   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template DA = dansk   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template DE = Deutsch   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template ET = eesti keel   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template EL = elliniká   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template EN = English   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template FR = français   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template IT = italiano   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template LV = latviešu valoda   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template LT = lietuvių kalba   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template HU = magyar   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template MT = Malti   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template NL = Nederlands   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template PL = polski   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template PT = português   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template RO = română   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template SK = slovenčina   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template SL = slovenščina   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template FI = suomi   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template SV = svenska   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template HR = Hrvatski   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template IS = Islenska   2009-06-19 2012-06-15  
Quality Review of Documents human annex-A template NO = Norsk   2009-06-19 2012-06-15  
Quality Review of Documents human annex related to the Article-127a template BG = bălgarski   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template ES = español   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template CS = čeština   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template DA = dansk   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template DE = Deutsch   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template ET = eesti keel   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template EL = elliniká   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template EN = English   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template FR = français   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template IT = italiano   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template LV = latviešu valoda   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template LT = lietuvių kalba   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template HU = magyar   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template MT = Malti   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template NL = Nederlands   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template PL = polski   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template PT = português   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template RO = română   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template SK = slovenčina   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template SL = slovenščina   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template FI = suomi   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template SV = svenska   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template HR = Hrvatski   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template IS = Islenska   2012-10-08    
Quality Review of Documents human annex related to the Article-127a template NO = Norsk   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template BG = bălgarski   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template ES = español   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template CS = čeština   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template DA = dansk   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template DE = Deutsch   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template ET = eesti keel   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template EL = elliniká   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template EN = English   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template FR = français   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template IT = italiano   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template LV = latviešu valoda   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template LT = lietuvių kalba   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template HU = magyar   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template MT = Malti   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template NL = Nederlands   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template PL = polski   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template PT = português   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template RO = română   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template SK = slovenčina   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template SL = slovenščina   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template FI = suomi   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template SV = svenska   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template HR = Hrvatski   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template IS = Islenska   2012-10-08    
Quality Review of Documents human annex-IV conditional positive template NO = Norsk   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template BG = bălgarski   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template ES = español   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template CS = čeština   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template DA = dansk   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template DE = Deutsch   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template ET = eesti keel   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template EL = elliniká   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template EN = English   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template FR = français   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template IT = italiano   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template LV = latviešu valoda   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template LT = lietuvių kalba   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template HU = magyar   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template MT = Malti   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template NL = Nederlands   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template PL = polski   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template PT = português   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template RO = română   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template SK = slovenčina   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template SL = slovenščina   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template FI = suomi   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template SV = svenska   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template HR = Hrvatski   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template IS = Islenska   2012-10-08    
Quality Review of Documents human annex-IV exceptional-circumstances positive template NO = Norsk   2012-10-08    
Quality Review of Documents human annex-IV standard positive template BG = bălgarski   2012-10-08    
Quality Review of Documents human annex-IV standard positive template ES = español   2012-10-08    
Quality Review of Documents human annex-IV standard positive template CS = čeština   2012-10-08    
Quality Review of Documents human annex-IV standard positive template DA = dansk   2012-10-08    
Quality Review of Documents human annex-IV standard positive template DE = Deutsch   2012-10-08    
Quality Review of Documents human annex-IV standard positive template ET = eesti keel   2012-10-08    
Quality Review of Documents human annex-IV standard positive template EL = elliniká   2012-10-08    
Quality Review of Documents human annex-IV standard positive template EN = English   2012-10-08    
Quality Review of Documents human annex-IV standard positive template FR = français   2012-10-08    
Quality Review of Documents human annex-IV standard positive template IT = italiano   2012-10-08    
Quality Review of Documents human annex-IV standard positive template LV = latviešu valoda   2012-10-08    
Quality Review of Documents human annex-IV standard positive template LT = lietuvių kalba   2012-10-08    
Quality Review of Documents human annex-IV standard positive template HU = magyar   2012-10-08    
Quality Review of Documents human annex-IV standard positive template MT = Malti   2012-10-08    
Quality Review of Documents human annex-IV standard positive template NL = Nederlands   2012-10-08    
Quality Review of Documents human annex-IV standard positive template PL = polski   2012-10-08    
Quality Review of Documents human annex-IV standard positive template PT = português   2012-10-08    
Quality Review of Documents human annex-IV standard positive template RO = română   2012-10-08    
Quality Review of Documents human annex-IV standard positive template SK = slovenčina   2012-10-08    
Quality Review of Documents human annex-IV standard positive template SL = slovenščina   2012-10-08    
Quality Review of Documents human annex-IV standard positive template FI = suomi   2012-10-08    
Quality Review of Documents human annex-IV standard positive template SV = svenska   2012-10-08    
Quality Review of Documents human annex-IV standard positive template HR = Hrvatski   2012-10-08    
Quality Review of Documents human annex-IV standard positive template IS = Islenska   2012-10-08    
Quality Review of Documents human annex-IV standard positive template NO = Norsk   2012-10-08    
Quality Review of Documents human periodic-safety-update-report annex-IV template BG = bălgarski   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template ES = español   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template CS = čeština   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template DA = dansk   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template DE = Deutsch   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template ET = eesti keel   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template EL = elliniká   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template EN = English   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template FR = français   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template IT = italiano   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template LV = latviešu valoda   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template LT = lietuvių kalba   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template HU = magyar   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template MT = Malti   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template NL = Nederlands   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template PL = polski   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template PT = português   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template RO = română   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template SK = slovenčina   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template SL = slovenščina   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template FI = suomi   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template SV = svenska   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template HR = Hrvatski   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template IS = Islenska   2014-03-19 2016-04-14  
Quality Review of Documents human periodic-safety-update-report annex-IV template NO = Norsk   2014-03-19 2016-04-14  
Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use (English only)   2016-02-09 2016-02-22  
Implementation plan for the revised QRD templates v9.1 (English only)   2015-06-10    
Policy on combined Summaries of Product Characteristics (SmPCs) (English only)   2015-06-10    

Mutual-recognition, decentralised, referral and PSUR single assessment (PSUSA) (Nationally Authorised Products only) procedures

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Document(s) Language Status First published Last updated Effective Date
Mutual-recognition, decentralised and referral product-information template version 4 BG = bălgarski   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 ES = español   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 CS = čeština   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 DA = dansk   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 DE = Deutsch   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 ET = eesti keel   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 EL = elliniká   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 EN = English   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 FR = français   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 IT = italiano   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 LV = latviešu valoda   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 LT = lietuvių kalba   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 HU = magyar   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 MT = Malti   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 NL = Nederlands   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 PL = polski   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 PT = português   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 RO = română   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 SK = slovenčina   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 SL = slovenščina   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 FI = suomi   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 SV = svenska   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 HR = Hrvatski   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 IS = Islenska   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 NO = Norsk   2011-08-30 2016-02-09  
Quality Review of Documents annex-I template for referrals BG = bălgarski   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals ES = español   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals CS = čeština   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals DA = dansk   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals DE = Deutsch   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals ET = eesti keel   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals EL = elliniká   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals EN = English   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals FR = français   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals IT = italiano   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals LV = latviešu valoda   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals LT = lietuvių kalba   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals HU = magyar   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals MT = Malti   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals NL = Nederlands   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals PL = polski   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals PT = português   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals RO = română   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals SK = slovenčina   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals SL = slovenščina   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals FI = suomi   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals SV = svenska   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals HR = Hrvatski   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals IS = Islenska   2009-06-19 2011-08-30  
Quality Review of Documents annex-I template for referrals NO = Norsk   2009-06-19 2011-08-30  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template BG = bălgarski   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template ES = español   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template CS = čeština   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template DA = dansk   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template DE = Deutsch   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template ET = eesti keel   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template EL = elliniká   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template EN = English   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template FR = français   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template IT = italiano   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template LV = latviešu valoda   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template LT = lietuvių kalba   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template HU = magyar   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template MT = Malti   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template NL = Nederlands   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template PL = polski   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template PT = português   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template RO = română   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template SK = slovenčina   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template SL = slovenščina   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template FI = suomi   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template SV = svenska   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template HR = Hrvatski   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template IS = Islenska   2015-09-15 2016-04-14  
Quality Review of Documents human periodic-safety-update-single-assessment Nationally Authorised Products template NO = Norsk   2015-09-15 2016-04-14  

Related links

The Agency does not publish English templates for 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.

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   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics ES = español   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics CS = čeština   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics DA = dansk   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics DE = Deutsch   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics ET = eesti keel   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics EL = elliniká   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics EN = English   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics FR = français   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics IT = italiano   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics LV = latviešu valoda   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics LT = lietuvių kalba   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics HU = magyar   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics MT = Malti   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics NL = Nederlands   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics PL = polski   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics PT = português   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics RO = română   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics SK = slovenčina   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics SL = slovenščina   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics FI = suomi   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics SV = svenska   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics HR = Hrvatski   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics IS = Islenska   2008-07-01 2009-11-04  
Appendix I - Statements for use in section 4.6 'pregnancy and lactation' of the summary of product characteristics NO = Norsk   2008-07-01 2009-11-04  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
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   2009-07-01 2010-02-09  
Appendix III to the Quality Review of Documents templates for human medicinal products (Cover page) (English only)   2008-07-31 2016-02-09  
Appendix III to the Quality Review of Documents templates for human medicinal products BG = bălgarski   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products ES = español   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products CS = čeština   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products DA = dansk   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products DE = Deutsch   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products ET = eesti keel   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products EL = elliniká   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products EN = English   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products FR = français   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products IT = italiano   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products LV = latviešu valoda   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products LT = lietuvių kalba   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products HU = magyar   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products MT = Malti   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products NL = Nederlands   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products PL = polski   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products PT = português   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products RO = română   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products SK = slovenčina   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products SL = slovenščina   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products FI = suomi   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products SV = svenska   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products HR = Hrvatski   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products IS = Islenska   2016-02-09    
Appendix III to the Quality Review of Documents templates for human medicinal products NO = Norsk   2016-02-09    
Appendix IV - Terms and abbreviations for batch number and expiry date to be used on the labelling of human medicinal products (English only)   2008-07-01 2014-04-30  
Appendix V - Adverse-drug-reaction reporting details (English only)   2013-03-15 2015-12-15