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Translation and the EMA Centralized Procedure

Technically, the EMA gives you five days to translate your SmPC and package insert into 24 languages. Don’t wait until the last minute!

This brief:

  • Offers an overview of translation requirements for the centralized procedure.
  • Provides helpful tips for a smooth translation process.
  • Shares guidelines to avoid common pitfalls.

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Download the Brief (Translation and the EMA Centralized Procedure)