Dossier
Documentation language and legalisation in practice
2026-01-08 · 3 min read
Which parts of a dossier typically require translation, and how that affects timelines.
What Changed
Dossiers submitted in English generally require translation of defined administrative and labelling elements rather than the entire technical file.
Who Is Affected
Manufacturers whose primary documentation language is not Russian.
What It Means
Translation and legalisation are separate third-party costs that sit outside both the professional fee and the state fee, and they can extend the overall project duration.
What Manufacturers Should Do
Identify the documents that must be translated during the gap analysis stage so translation runs in parallel with dossier preparation instead of after it.
Source: REGVIA regulatory practice note