Tomedes Supports a U.S. Life Sciences Company's EMA Market Authorization with Drug Labeling Translation from English to Polish

See how Tomedes translated a prescription drug labeling package from English into Polish for a U.S. life sciences company preparing a centralized marketing authorization application with the European Medicines Agency.

About the Client

A U.S.-based life sciences company specializing in specialty pharmaceuticals had developed a prescription medication for a chronic condition with significant patient prevalence across Central and Eastern Europe. Having secured regulatory approval in the United States, the company was pursuing a centralized marketing authorization application through the European Medicines Agency — a process that would, if successful, grant simultaneous market access across all EU member states.

Poland represented one of the company's primary target markets within the EU, both for its patient population size and its position as a gateway to broader Central and Eastern European distribution. The Polish labeling package was therefore not a secondary deliverable, it was a core component of the company's European market entry strategy.

Industry and Services

• Life Sciences
• Pharmaceuticals Regulatory
• Document Translation
• English to Polish

The Challenge

Drug labeling translation for an EMA marketing authorization application is among the most technically and regulatorily demanding categories of pharmaceutical translation. The labeling package is not a marketing document — it is a regulatory artifact that defines how a medicine is described, prescribed, dispensed, and used across an entire market. Every word in a Summary of Product Characteristics, package leaflet, or labeling annex carries defined regulatory meaning, and the Polish translations submitted to EMA must satisfy both the agency's linguistic standards and Poland's national regulatory requirements. The company faced three challenges that required a specialist translation workflow from the outset.

1. EMA regulatory language conventions requiring alignment with established Polish pharmaceutical terminology

The EMA's centralized procedure requires that labeling translations conform to the terminology and language conventions established in the EMA's own reference documents — the QRD templates, which define the standard structure and approved language for SmPCs, package leaflets, and labeling annexes across all EU official languages. Polish pharmaceutical regulatory language has its own established conventions for describing indications, contraindications, adverse reactions, dosage instructions, and pharmacological properties — conventions that differ from general medical Polish and from direct translations of the English source text.

A translator unfamiliar with EMA QRD template conventions in Polish, or who rendered regulatory language using general pharmaceutical vocabulary rather than the established EMA register, would produce a labeling package that was linguistically accurate but regulatorily non-standard — a submission risk that could trigger EMA queries during the assessment process and delay market authorization.

2. Consistency across a multi-document labeling package

A complete EMA labeling package comprises multiple interconnected documents: the Summary of Product Characteristics, the package leaflet for patients, the labeling text for the outer and immediate packaging, and associated annexes. These documents are not independent — they reference each other, share terminology, and must present consistent information about the medicine's indications, dosage, contraindications, and safety profile across all components. A terminology inconsistency between the SmPC and the package leaflet (even a synonym substitution that was linguistically defensible) could create a discrepancy that EMA assessors would flag during linguistic review.

Maintaining full consistency across all components of the labeling package required a single terminology framework applied uniformly from the first document to the last, with cross-document review conducted before submission.

3. Patient-facing language in the package leaflet requiring plain Polish accessible to non-specialist readers

The Summary of Product Characteristics is written for healthcare professionals — its register is technical, precise, and assumes a professional medical readership. The package leaflet is written for patients — and EU pharmaceutical regulation requires that package leaflets be written in language that is clear, legible, and comprehensible to patients, using plain language principles that make clinical information accessible to a general adult readership. In Polish, this distinction requires active editorial judgment: the same clinical concept must be rendered in technical register in the SmPC and in plain, accessible Polish in the package leaflet, using vocabulary and sentence structures that a patient without medical training can understand and act on correctly.

Why Tomedes?

The company selected Tomedes for its ISO 17100:2015 certification and its ability to source a translator with direct experience in EMA regulatory labeling documentation in Polish. The SmPC and package leaflet components in particular required a linguist with familiarity with both EMA QRD template conventions and the established Polish regulatory vocabulary used in centralized procedure submissions, a combination that Tomedes was able to identify within its network of specialist pharmaceutical translators.

A dedicated project manager with experience coordinating regulatory translation projects for EMA submissions structured the workflow to include a pre-translation terminology alignment stage and a cross-document consistency review before delivery.

The Solution

1. Pre-translation EMA QRD terminology alignment

Before translation began, Tomedes conducted a terminology alignment exercise using the EMA's published Polish-language QRD templates and reference labeling documents as the primary reference — cross-referencing the company's source labeling against the established Polish regulatory equivalents for each key term across the SmPC, package leaflet, and labeling annexes. Where the English source text used terminology that did not map directly to an EMA QRD-approved Polish equivalent, Tomedes flagged the item and worked with the company's regulatory affairs team to agree on an appropriate rendering before translation started. The resulting bilingual glossary was applied consistently across all components of the labeling package throughout the translation process.

2. A specialist translator with EMA regulatory labeling experience

The translation was handled by a Polish pharmaceutical translator with documented experience in EMA centralized procedure labeling submissions, including prior work on SmPCs and package leaflets across multiple therapeutic areas. The translator applied the approved glossary throughout, rendered the SmPC in the technical regulatory register appropriate for healthcare professional labeling, and produced the package leaflet in plain Polish aligned with EU plain language requirements for patient-facing pharmaceutical materials. The labeling annex and packaging text were translated with full cross-reference to the SmPC to ensure consistency of all clinical information across the full package.

3. Cross-document consistency review before delivery

Following the main translation pass, a second Polish pharmaceutical specialist conducted a cross-document review — checking that all shared terminology, clinical claims, dosage information, contraindication language, and safety profile descriptions were presented consistently across the SmPC, package leaflet, labeling annex, and packaging text. The review produced a set of targeted revisions focused on terminology alignment and register consistency, which were incorporated before the final package was assembled. The complete labeling package was delivered as submission-ready documents formatted to EMA requirements.

The Result

When the company's regulatory affairs team assembled their centralized marketing authorization application, the Polish labeling package was ready for direct submission — terminology aligned to EMA QRD standards, consistent across all components, and with a patient-facing package leaflet written in plain Polish that met EU comprehensibility requirements.

The labeling package was submitted as part of the company's EMA application without Polish-language queries raised during the linguistic review stage of the assessment process. The company's Central and Eastern European market entry timeline proceeded without regulatory language delays.

Regulatory language is not a formality, it is part of the authorization itself. Tomedes' role in this project was to make sure the Polish labeling met the standard that EMA assessors expect, and that patients in Poland would receive a package leaflet written for them.

Are you a life sciences company preparing labeling translation for an EMA marketing authorization application or national regulatory submission in Central or Eastern Europe? Contact Tomedes today for a free consultation.

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