Navigating Inconsistencies in International Pharma Labeling Requirements

Pharmaceutical Translations of International Labels

We’ve blogged about the need for professional certified translation services of product warning labels, as well as professional translation of “Made in USA” labels. In the US, the Food and Drug Administration has strict labeling requirements for many products, like cosmetics, for example. And just as the US has its own specific requirements, so do nearly every other country on the planet.

For example, in the cosmetics sector, the labeling requirements for describing color additives for products entering the US are different than those for Canada and Europe. Added into this mix is the need for labeling to be included in different languages, requiring a foreign language translation done in compliance with different foreign jurisdictions (for example, for some products, the label translation requirements for France and French-speaking Belgium can differ).

Needless to say, there are many inconsistencies between what one country and the next requires, which causes a great deal of confusion for any company distributing products abroad. Fortunately, one can navigate these waters (at least for import/export within the US, Canada and most of Europe) with the use of a single label satisfying all labeling requirements. The first step is to determine what each jurisdiction’s requirements are and then draft content that satisfies all requirements, including any need for a foreign language translation.

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