EU CTR - EudraLex Volume 10: Q&A Annex II: Language requirements for part I documents

Dear All,

the EudraLex Volume 10 Q&A document now contains the language translations requirements (at least for some of the Member States) for part I data/documents.

See Annex II: Language requirements for part I documents

At first glance:

• Majority of MS require mainly the protocol synopsis and the labels in national languages, but there are some MS (e.g. Greece) with quite extensive translation requirements.
• Only few MS(s) require translations of the structured data of the application form, a clear benefit for update versioning of the application form against tight timelines (e.g. RFI responses).
• Interestingly, several MS(s) require the cover letter to be translated, which would be interesting for SMs covering part I and parts II of several MSC, where the changes in each MSC part II may differ by country.

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