Periodic Safety Update Reports (PSURs), PSUR translation sit at the centre of post-marketing pharmacovigilance in Europe. Every marketing authorisation holder knows they are part of the ongoing obligation to monitor a medicine’s benefit-risk profile. Yet one question continues to create confusion:
Does a PSUR need to be translated?
The short answer is no.
The PSUR itself is generally submitted in English. The translation work begins only if the regulatory assessment leads to changes in the approved product information.
Understanding that distinction helps regulatory, safety, and localization teams plan resources more effectively and avoid unnecessary translation costs.
What is a PSUR?
A Periodic Safety Update Report (PSUR) is a regulatory document that assesses a medicinal product’s safety and benefit-risk balance over a defined reporting period using cumulative safety data.
A typical PSUR includes:
- Safety data and emerging signals
- Benefit-risk evaluation
- Patient exposure estimates
- Safety-related actions
- Conclusions and recommendations
Legal basis
PSUR requirements are established under:
- Directive 2001/83/EC, as amended by Directive 2010/84/EU
- Regulation (EC) No 726/2004, as amended by Regulation (EU) No 1235/2010
- Commission Implementing Regulation (EU) No 520/2012
Also read: Post-Market Surveillance Translations: What Documents You Need, And When
PSUR or PBRER: are they the same thing?
Almost. The Periodic Benefit-Risk Evaluation Report (PBRER) is the internationally harmonised format introduced under ICH E2C(R2). In the European Union, however, regulators continue to use the term Periodic Safety Update Report (PSUR).
In practice:
- PBRER refers to the ICH report format.
- PSUR is the regulatory term used throughout the EU pharmacovigilance framework.
Although the names differ, the terms are often used interchangeably because EU PSURs largely follow the PBRER structure.
PSUR Submission Timelines and the EURD List
Submission frequency is not chosen by the authorisation holder. It is fixed by the EURD list, the European Union reference dates and frequency of submission list.
The list does two things. It sets the data lock point, which is the cut-off date for data included in the report. It sets how often the report is due for each active substance.
Because frequency is harmonised at substance level, every holder of that substance works to the same data lock point. That is what makes single assessment possible.
The EURD list is a living document. The EMA updates it monthly. Working from a cached copy is a known source of missed deadlines.
Submission windows
Once the data lock point passes, the clock starts.
For reporting intervals of 12 months or less, submission is generally due within 70 calendar days of the data lock point.
For reporting intervals of more than 12 months, the window is generally 90 calendar days.
For ad hoc requests from a competent authority, the deadline is stated in the request.
What Language Is a PSUR Submitted In?
For European submissions, the PSUR is generally prepared and submitted in English through the PSUR Repository managed by the European Medicines Agency.
This applies to:
- Centrally authorised products
- Products included in EU single assessments (PSUSA)
- Many nationally authorised products participating in the shared assessment process
The scientific assessment takes place using the English-language report. Translation requirements arise only if the assessment results in updates to the approved product information.
This is an important distinction because many organisations assume the PSUR must later be translated into every European language.
Where does translation actually become mandatory?
Product information updates after a PSUSA outcome
All reports on the same active substance are assessed together. This is the PSUR single assessment procedure, or PSUSA. One assessment covers every authorisation holder of that substance across the EU.
If the outcome changes the product information, each holder must implement it through a variation. Centrally authorised products follow a Commission Decision. Nationally authorised products follow a CMDh position and then national action.
The updated product information is needed in the language of every market where the product is authorised. One new adverse reaction or one revised warning can trigger translation work across an entire European portfolio.
The SmPC, package leaflet, and labelling
Three documents typically require translation following an approved safety update.
The Summary of Product Characteristics is the prescriber-facing document. It is technical, precise, and legally binding.
The package leaflet is patient-facing. It must be readable by a lay audience, which makes it harder to translate well than the SmPC.
The labelling covers outer carton and immediate packaging text. Character limits and physical space make this the most operationally difficult of the three.
For centrally authorised products these exist in all 24 official EU languages. Icelandic and Norwegian are added for the wider European Economic Area. That is 26 language versions moving in step for one safety change.
Also read: How EPI Will Improve Translation And Labeling In The EU
The DHPC
A Direct Healthcare Professional Communication is issued when a safety finding needs to reach prescribers quickly and directly.
Unlike the PSUR, a DHPC has no English-only route. It lands on the desk of a practising clinician, so it must be in the working language of that clinician.
Translation into local languages is mandatory, and the timelines are shorter than for a routine variation because the communication is urgent by definition.
Teams that plan only for product information updates get caught here.
Linguistic review and QRD templates
Translations are reviewed rather than simply accepted. National competent authorities check the language versions for accuracy and compliance during linguistic review.
Structure is fixed by the QRD templates, maintained by the Quality Review of Documents group. These prescribe headings, standard phrases, and required sections across the SmPC, labelling, and package leaflet. Standard statements have approved translations in every language.
Translators are not free to choose phrasing here. They are matching a controlled template, in the correct version, in every language at once.
EMA-Ready QRD Translations For Regulatory Affairs Teams
Turnaround windows
Linguistic review runs on short fixed cycles measured in working days. Translations go in, Member States comment, revised versions come back.
Two consequences follow.
There is no room for vendor onboarding once the outcome lands. Selecting a translation partner after the assessment concludes means starting behind.
Review comments arrive in a burst across many languages at once. Capacity has to be available in parallel.
Language Requirements Across EU Member States
The 27 EU Member States use 24 official languages between them. The mapping is not one country to one language.
| Market | Language(s) required | Notes |
|---|---|---|
| France | French | No other language accepted for patient-facing text |
| Germany | German | Strict on form and content |
| Spain | Spanish (Castilian) | Regional languages optional, not required |
| Italy | Italian | Standard Italian |
| Portugal | Portuguese | European Portuguese, not Brazilian |
| Netherlands | Dutch | Multilingual packaging sometimes permitted |
| Belgium | Dutch, French, German | Three official languages on labelling |
| Finland | Finnish and Swedish | Full bilingual requirement |
| Luxembourg | French and German | Confirm current practice per product |
| Poland | Polish | Specific national phraseology conventions |
| Czech Republic | Czech | Narrow tolerance on formal documents |
| Greece | Greek | Greek alphabet required |
| Bulgaria | Bulgarian | Cyrillic required, transliteration not accepted |
| Sweden | Swedish | Own terminology conventions |
| Denmark | Danish | Local QRD format applied strictly |
| Romania | Romanian | Clarity requirements for patient text |
| Hungary | Hungarian | Close semantic review |
| Ireland | English | Irish is official, English used in practice |
| Malta | Maltese and English | Confirm current position per product type |
| Cyprus | Greek | Confirm current position |
The bolded rows are the ones that break project estimates. Belgium alone can triple the volume budgeted for one country.
Markets outside the EU procedure
Two markets sit outside the PSUSA outcome but usually inside the same portfolio.
Switzerland is regulated by Swissmedic. Professional and patient information are required in German, French, and Italian. Swissmedic runs its own timelines and does not implement EU outcomes automatically.
The United Kingdom is regulated by the MHRA and works in English. UK submissions have been separate from the EU procedure since Brexit.
Since 1 January 2025, the MHRA has operated as the single licensing authority across England, Scotland, Wales and Northern Ireland. Companies marketing in both the EU and the UK should plan for separate regulatory procedures and product information updates.
What goes wrong in PSUR-driven translation?
1. National implementation delays
Implementation often slows at the national level rather than during the EU assessment. A Pharmacia study found that delays in implementing PRAC and CMDh recommendations can postpone updated safety information reaching healthcare professionals and patients.
2. Terminology drift
The PSUR and updated SmPC are often prepared by different teams. Without a controlled terminology base, approved safety terms can become inconsistent across product information.
3. Version control issues
A single safety update may involve more than 24 language files. Poor version control can leave some markets using outdated product information.
4. Safety wording that changes meaning
Terms describing frequency, severity, and causality have specific regulatory meanings. Small translation changes can alter the intended message and create compliance risks.
5. Missing review deadlines
Linguistic review comments often arrive from multiple Member States at once. Delays in responding can postpone the variation and the implementation of updated safety information.
Also read: Changes To EU MDR & IVDR: What It Means To Translation
Preparing Before the Outcome Lands
Preparation starts well before the regulatory assessment concludes.
1. Build a terminology base
Create a maintained terminology database from approved SmPCs, package leaflets, and QRD standard statements to keep safety wording consistent across all languages.
2. Keep translation memories current
Align translation memories with the latest QRD template version so only new or revised text requires translation during a variation.
3. Reserve linguistic capacity
Secure qualified life science linguists in advance, especially for lower-volume languages where availability is more limited.
4. Verify quality systems
Work with a translation partner that follows recognised quality standards, such as ISO 17100, ISO 13485, and ISO 9001, to support regulatory compliance and audit readiness.
Need Help Navigating EU PSUR Translations?
FAQs
Do I need to translate my PSUR?
No. PSURs are submitted to the PSUR Repository in English. Translation applies to the product information updated as a result of the assessment.
Is a PSUR the same as a PBRER?
Functionally yes. PBRER is the ICH E2C(R2) name and format. The EU adopted the format and kept the name PSUR. What is the PSUR Repository? The central EMA platform through which all PSURs are submitted. It has been the mandatory channel since June 2016.
Does every product need a PSUR?
No. Generics, well-established use products, homeopathic products, and traditional herbal products are exempt from routine submission unless the EURD list, a condition of authorisation, or a competent authority requires one.
Who reviews the translated product information?
For centrally authorised products, the EMA coordinates a linguistic review involving Member States to ensure the translated product information complies with QRD templates and accurately reflects the English reference text. National procedures follow the relevant competent authority’s review process.
How many languages will I need?
For a centrally authorised product, 24 official EU languages plus Icelandic and Norwegian for the EEA. For nationally authorised products, the languages of your authorised markets, remembering that Belgium, Finland, Luxembourg, Malta, and Cyprus each need more than one.
