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.

Linguistic review process

The linguistic review process of product information in the centralised procedure - Human

Reference Number: EMEA/5542/02 Rev. 5.1*

Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review

Checklist for the submission of Day 215 product information annexes for a post-opinion linguistic review (Word file)

QRD Form 1: For Member States' product information check

Member states contact points for translations review

Reference Number: EMA/102302/2005 v. 6.5

• Scientific and other guidelines
• Practical information on translations for referral procedures (human)

Provision of final language versions

User guide on how to generate PDF versions of the product information - human

Reference Number: EMEA/524020/2007 Rev. 5

Submission of day +25 /235 final product information annexes (human and veterinary) - QRD Form 2 and checklist

Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates

AdoptedLegal effective date: 01/06/2007Reference Number: EMA/62470/2007

Standard operating procedures

Standard operating procedure for Product Information Quality / Quality Review of Documents pre-opinion review of product information for renewal procedures

AdoptedLegal effective date: 15/12/2010Reference Number: SOP/EMA/0046

Standard operating procedure for Quality Review of Documents post-opinion review of product information for initial applications and annex-II applications

AdoptedLegal effective date: 15/12/2010Reference Number: SOP/EMEA/0047

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

AdoptedLegal effective date: 15/12/2010Reference Number: SOP/EMEA/0048

Standard operating procedure for handling of financial compensation for checking of product information by the Member States

AdoptedLegal effective date: 17/12/2010Reference Number: SOP/H/3060