Linguistic review
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The linguistic review process of product information in the centralised procedure - veterinary (PDF/743.73 KB)
First published: 18/12/2006
Last updated: 07/02/2011
EMEA/288844/2009 Rev 4* -
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Product-information-quality form: For applicants when submitting revised English product information to the European Medicines Agency - Day 121 (DOC/480.5 KB)
First published: 19/06/2009
Last updated: 06/05/2010 -
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QRD Form 1: For Member States' product information check (DOC/536 KB)
First published: 19/06/2009
Last updated: 10/06/2015 -
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Member states contact points for translations review (PDF/131.4 KB)
First published: 21/04/2009
Last updated: 06/10/2022
EMA/102302/2005 v. 6.23
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User guide on how to generate PDF versions of the product information - veterinary (PDF/243.76 KB)
First published: 07/02/2011
Last updated: 29/03/2022
EMA/793983/2010 v.3.0 -
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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
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.