For centrally authorized medicines, EMA has a checking process for the mock-ups and specimens of outer and immediate labeling and package leaflets. The mock-up is reviewed as part of the application, and the specimens are checked later against what was approved. National authorities have similar processes for medicines authorized nationally.

Why it matters for labeling

The printed packaging has to match what was reviewed. A specimen that differs from the approved mock-up, for example in layout, text, Braille or safety features, can lead to rework and delay a launch. That makes the final artwork check against the approved version, not just against the previous draft, a regulatory step as well as a quality one.

Common mistakes

  • Final artwork changed after mock-up approval without telling the authority
  • Text in a language version that differs from the approved product information
  • Missing or altered Braille, safety features or national information
  • A specimen produced from a different file than the approved mock-up

Sources