Official EU Languages & Labeling Requirements -- MEDICA - World Forum for Medicine


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Official EU Languages & Labeling Requirements

The last to join the European Union were Romania and Bulgaria in January 2007. Since then, the European Union numbers 27 European States in which 23 different official languages are spoken.

Through this union many different regulations were harmonized among the Member States, while harmonizing language is yet to be achieved. Many believe there is a common language spoken in the European Union but that is of course not the case.

Whenever planning to commercialize products in any of the EU Member States the national language(s) is an essential part of the manufacturer’s European Strategy.

The European Directives & Regulations bring the direction of the European Commission to the member states while the implementation of such laws is under the individual parliaments of the 27 EU states - an excellent example of such implementation is the national provisions on the elements of labels (outer packaging, leaflets, instructions for use and others) which must be translated to the national official languages – these rules are referred to as “Language Requirements”. In some cases, when there are multiple official languages in one country it may be decided to have the labels translated only in some of the languages and not all.

Here below are practical examples:

In Belgium the official languages are French, Dutch and German but labels may be translated only to French and Dutch.
In Malta the official languages are Maltese and English but labels may be translated to either one of these languages.
Click here to download the table of the official languages in the European Union.


-This table is subject to change as per the national provisions.
-Official EU languages are not the official language requirements.