Within EU Application Procedures, the Product Information documents are approved by the Authority as English versions but must then be provided in all relevant EU languages (currently up to 25 EU / EEA languages).
Regulations require “high quality” and "faithful" translations to be set up and the final approval process involves a linguistic review of the language versions by the respective Member States.
CoreX provides a comprehensive “one-stop-shopping” labelling package that starts with support for the English Product Information and ends with the submission of the final agreed language versions to the Authorities.
As our service includes the management of the whole labelling process, CoreX involvement will provide added value in terms of regulatory and strategic expertise, additional resources and procedural experience (up to established contacts to Health Authority reviewers) to run the linguistic review process smoothly and within the tight timelines defined by the Authorities.
CoreX Regulatory Consulting GmbH
Rosa-Luxemburg-Str. 2
79100 Freiburg
Germany
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