Linguistic review - Human
Please be reminded that in accordance with Union data protection requirements, no personal data should be included in the annotated PIs. This applies to the English version and all the translations. Please submit annotated PIs in an anonymised format (i.e. names of the reviewers removed from the track-changes). If you do not wish to do so, please ensure that the individuals whose data is included consented to its sharing with EMA and its further sharing by EMA with third parties such as other marketing authorisation applicants, marketing authorisation holders and National Competent Authorities, as relevant. EMA expressly disclaims any liability or accountability for the presence of unnecessary personal data in the annotated PI submitted by the marketing authorisation holder.
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The linguistic review process of product information in the centralised procedure - Human (PDF/873.33 KB)
First published: 15/10/2008
Last updated: 24/07/2017
EMEA/5542/02 Rev. 5.1* -
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Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (PDF/182.52 KB)
First published: 10/06/2015
Last updated: 08/02/2021 -
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Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file) (DOCX/113.34 KB)
First published: 19/03/2021 -
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QRD Form 1: For Member States' product information check (DOCX/3.24 MB)
First published: 19/06/2009
Last updated: 10/06/2015 -
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Member states contact points for translations review (PDF/137.85 KB)
First published: 21/04/2009
Last updated: 30/08/2023
EMA/102302/2005 v. 6.3
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User guide on how to generate PDF versions of the product information - human (PDF/585.46 KB)
First published: 21/04/2009
Last updated: 07/05/2018
EMEA/524020/2007 Rev. 5 -
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Submission of day +25 /235 final product information annexes (human and veterinary) - QRD Form 2 and checklist (DOCX/133.65 KB)
First published: 19/06/2009
Last updated: 19/03/2021 -
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Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates (PDF/92.33 KB)
Adopted
First published: 01/06/2007
Last updated: 15/04/2011
Legal effective date: 01/06/2007
EMA/62470/2007
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Standard operating procedure for Product Information Quality / Quality Review of Documents pre-opinion review of product information for renewal procedures (PDF/85.71 KB)
Adopted
First published: 30/04/2008
Last updated: 15/12/2010
Legal effective date: 15/12/2010
SOP/EMA/0046 -
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Standard operating procedure for Quality Review of Documents post-opinion review of product information for initial applications and annex-II applications (PDF/101.42 KB)
Adopted
First published: 08/04/2009
Last updated: 15/12/2010
Legal effective date: 15/12/2010
SOP/EMEA/0047 -
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Standard operating procedure for Quality Review of Documents post-opinion review of product information for post-authorisation procedures affecting the annexes, excluding annex-II applications (PDF/115.17 KB)
Adopted
First published: 08/04/2009
Last updated: 15/12/2010
Legal effective date: 15/12/2010
SOP/EMEA/0048 -
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Standard operating procedure for handling of financial compensation for checking of product information by the Member States (PDF/96.74 KB)
Adopted
First published: 25/04/2008
Last updated: 20/12/2010
Legal effective date: 17/12/2010
SOP/H/3060