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Linguistic Review is the translation and review process for all new and updated Product Information (PI) that is required post-opinion for all products authorised by the European Centralised Procedure (CP) to ensure high quality and consistent PIs in all Member States.
Linguistic Review is a standardised 25-day process, covering 25 European languages including Icelandic and Norwegian and is required for a new PI within the initial Marketing Authorisation Application (MAA) and for the updated PI resulting from variations to the Marketing Authorisation (MA).
While the Linguistic Review process is similar for MAAs, variations, and updates following the PSUR processes, there are some differences e.g. for the timelines and the documentation required for the submission of the PI to EMA.
The EMA working group on Quality Review of Documents (QRD) has developed and published QRD Templates for the PI in each language to guide applicants on the translations, as well as a QRD Convention and a Style Guide document to define the formatting and stylistic requirements of the PI. These documents are updated regularly with the purpose of maximising linguistic accuracy and clarity of the information and scientific terminology contained within the PI. This results in an accurate and identical set of PIs for the MA in all Member States.
At the initial submission and during assessment of MAAs, only the English language of the PI is submitted and reviewed but each translation will be subject to the Member States’ Linguistic Review after the final English PI is available. This final English PI must be of high quality, compliant with all QRD requirements and written using clear unambiguous wording.
For an initial MAA the pre-opinion on the English PI is provided on day 120, and the applicant should provide an updated English PI by day 121. The Agency will review the implementation of any comments by the applicant and will forward any other comments from Patient Organisations and EMA medical writers to the applicant by day 150. The applicant has up to day 181 to submit the updated English PI to the agency for review.
For an initial MAA, day 181 has turned out to be a good time to commence the translations for the remaining languages, as at this point the applicant is submitting an updated PI in which all major issues are resolved and which has undergone all formal scheduled reviews by EMA.
Following CHMP opinion on the initial MAA on day 210 (day 0 for type IB and type II variations), translations of the PI have to be submitted by day 215 (day +5) together with the Day 215 checklist. Following this submission, each Member State will review the translations within 14 days i.e. until day 229 (day +19).
After receiving the MS comments on the translations the MAH again has five calendar days to create the final set of PI translations that always includes one set of word-files in “tracked-changes-mode”, one set of word-files in “clean-version”-mode and the respective set of pdf files published and bookmarked according to the EMA Guidance document.
The submission of these final translations to EMA on day 235 (day +25) closes the Linguistic Review Process for an initial MAA and type II variations.
For type IA, IB variations and Article 61(3) notifications that affect the PI, annotated word-files and clean pdf-files of the PI have to be provided to the agency already at the time of variation submission, however. Linguistic Reviews are only carried out for type IB variations and some Article 61(3) notifications but not for type IA variations.