Labelling is often treated as the final step before launch. In the GCC, it should be one of the first. Authorities require bilingual labelling and Arabic patient information, and errors here can stop a shipment at the border or trigger a rejection.
What must be right
Bilingual outer and inner packaging with consistent content across languages.
Arabic patient information leaflet that is medically accurate, not just translated.
Consistency with the approved dossier – strengths, excipients, storage and warnings.
Country-specific requirements – each GCC authority has its own details.
Medical device labelling – symbols, instructions for use and authorised-representative details.
Common errors
Literal translation that changes clinical meaning.
Terminology inconsistent with authority-approved wording.
Artwork updated in one market but not in others.
Right-to-left layout errors in printed artwork.
A better process
Prepare the Arabic master text in parallel with the dossier.
Use qualified medical-regulatory linguists, not general translators.
Run a side-by-side review against the approved product information.
Keep version control for every market.
How HERMS supports
HERMS prepares and reviews Arabic labelling, leaflets and artwork for pharmaceuticals, medical devices, cosmetics, supplements and herbal products across the GCC.
Send your artwork to HERMS for a pre-submission compliance review. Contact HERMS →