Product information translation and labeling translation: latest EMA updates

The European Medicines Agency (EMA) issued updated guidelines in June 2022 for stylistic decisions in the Quality Review of Documents (QRD) relating to product information translation. A few updates related to multilingual labeling and packaging in an effort to address some recurrent translation errors in the context of QRD compliance.

What was updated? One of the style changes belongs to active voice. They asked manufacturers to write or translate the package leaflets using active voice, giving special attention to “instructions about shelf-life, storage, handling, and disposal.” The use of active voice allows for more information to be included in a sentence. This can be useful when space might be an issue and it also makes sentences more interesting to read.

There is often confusion in some languages when particular terms are translated literally. The EMA has suggested that the term “drug” should be avoided in the product information annex. It might lead to a mistranslation in other languages. Also, “in most Member States the term has connotations of narcotics or illicit drugs.”

Nevertheless, the term “drug” can be used in compound terms like adverse drug reaction, drug interaction, etc.

As to using of abbreviations or short terms the new guideline also addresses differences between English and “other languages” in multilingual packaging. They can be used in translations, but manufacturers have to make sure to get clearance from the EMA first.

To be complied with labeling regulations, it is needed to translate the full terms “in normal text, followed by the agreed short term/abbreviation in gray-shading.”

Main revisions

Regarding decimal separators, the revised guidance now applies to all product information, not just specific sections. The agency states that numbers after the period or the comma need to be written without any spacing, for example, 0.4759 or 0,3589.

They also approve standard ISO 80000-1, which requires the use of spaces on numbers of three or more digits (e.g., 1 000; 1 000 000) instead of commas or dots, which should continue to be used for decimals. 

Updates made to the term “unit dose” concern Maltese and German translations. It is included revised translated equivalents. There are also changes regarding The International System of Units (SI).

The EMA also revised guidelines related to the International Nonproprietary Name (INN) or generic product name. These guidelines cover the “Use of EN or Latin Translation of INNs in Product Information Annexes”, for example, minding “(BE examples and PL requirement)”.

Unnecessary repetition of the invented name in the product information annexes must be avoided. The INN, pronouns, or alternative terms (e.g. ‘treatment’) should be used whenever possible in the SmPC; in particular, the INN should be used when reference is made to the properties of the active substance. In the package leaflet, the term “this medicine” should be used.

Also on the pages of our blog, you can read more about general information on translation requirements for clinical trial translations and medical translations, and how to manage clinical research translations during the international multicenter clinical study.

Want to share this post?


Get a Quote