An EMA linguistic review has come back with comments on five of your 24 language versions. A national competent authority has flagged readability issues with the German leaflet during a national approval cycle. A variation scoped two months ago is now blocked because the LSP has not loaded the v10.4 QRD template into their workflow.
These situations share one cause. Package leaflet translation got scoped at the wrong stage of the marketing authorisation programme, treated as a finishing step rather than as a regulated deliverable inside the submission. Package leaflet translation is the work of producing the patient leaflet, the Summary of Product Characteristics, and the labelling in every language the marketing authorisation requires, under Directive 2001/83/EC, Regulation (EC) 726/2004, and the EMA’s Quality Review of Documents (QRD) template.
This guide is for the regulatory affairs lead, head of labelling, or quality and compliance manager running EU and UK pharma submissions. It gives you the document type matrix, the procedure-by-procedure language scope, the EMA 25-day linguistic review as an operational table, the Windsor Framework treatment, and a vendor evaluation checklist that lifts into a supplier RFP. For the deeper read on quality methodology, see the AdHoc cluster piece on medical translation quality assurance, and for an overview of how we structure pharma-grade medical translation work, see our service page.
TL;DR
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What EU pharma translation actually requires
EU pharma translation sits under Directive 2001/83/EC, which sets the rules for medicinal products across all member states, and Regulation (EC) 726/2004, which gives the European Medicines Agency its role in the centralised procedure. Title V of the Directive (Articles 54 to 69) covers labelling and the package leaflet. Article 63(1) is the language anchor: the particulars on outer packaging and the leaflet must appear in the official language or languages of the member state where the medicinal product is placed on the market. The QRD template, maintained by the EMA’s Working Group on Quality Review of Documents, is the operational artefact through which the regulation gets enforced in practice.
The legal anchor: Directive 2001/83/EC and Regulation (EC) 726/2004
The Directive sets out what must appear in the SmPC (Article 11), the labelling (Article 54), and the patient leaflet (Article 59). Regulation 726/2004 governs the centralised procedure run through the EMA. Both apply at the same time for centrally authorised products. National competent authorities such as BfArM in Germany, ANSM in France, AEMPS in Spain, AIFA in Italy, the MEB in the Netherlands, the MPA in Sweden, and Lægemiddelstyrelsen in Denmark enforce the Directive at member-state level. The language scope follows the markets where the marketing authorisation is granted, not a blanket EU-wide rule.
The QRD template as the working tool
The QRD template is what the LSP works from in practice. It specifies the heading structure, mandatory phrases, formatting conventions, and pre-approved translations for common terms. Versions matter. The current version 10.4 (last updated 25 March 2026 on the EMA site) was specifically revised to delete “United Kingdom (Northern Ireland)” from the local representatives section, aligning with the Windsor Framework. An LSP still working from a pre-v10.4 template is shipping an outdated leaflet. Version 11 was open for public consultation until 31 August 2025, with the revision focused on improving package leaflet readability for patients. Any pharma RA team without visibility into which QRD version their supplier is loaded onto is carrying unnecessary submission risk.
Which documents need translation
Four document types fall inside EU pharma translation scope: the Summary of Product Characteristics (SmPC), the package leaflet (PL or PIL), the labelling, and Annex II of the marketing authorisation. Each has its own purpose, its own readership, and its own translation rules. Most pharma buyers know the SmPC and PIL split. Labelling and Annex II are the workstreams that get under-resourced.
| Document type | Primary reader | Regulatory function | Key translation requirement |
|---|---|---|---|
| SmPC (Annex I) | Healthcare professionals | Prescribing information; Article 11 of Directive 2001/83/EC | MedDRA terms in section 4.8; EMA Standard Terms in section 3 |
| Package leaflet (Annex IIIB) | Patients | Patient information; Article 59 of the Directive | Plain language; readability tested; EMA readability guideline |
| Outer carton labelling | Patients, dispensers | Article 54 of the Directive | Space-constrained; EMA Standard Terms; multilingual layout |
| Immediate packaging labelling | Patients, dispensers | Article 55 of the Directive | Minimum particulars; abbreviation rules; small-container exemption |
| Blister foil text | Patients, dispensers | Article 55(2) of the Directive | Severe space constraint; standard particulars only |
| Annex II — conditions of MA | Regulators, MAH | Conditions of supply, classification, local representatives | Local representatives section updated in QRD v10.4 (UK NI removed) |
| Labelling for multilingual carton | Patients across markets | Single carton for multiple markets | Consistent translation across all panel languages; artwork-aware |
| National blue box content | National competent authority | Country-specific information added to label | Member-state-specific text; national CA preferences |
| “UK Only” label (UK only) | UK regulators and supply chain | Windsor Framework; effective 1 January 2025 | Minimum 7-point font per EU Regulation 2023/1182 Article 5 |
SmPC: for healthcare professionals
The SmPC is the expert-to-expert document. Used by prescribers and pharmacists. The content requirements are defined in Article 11 of the Directive. Section 4.8 covers adverse reactions and must use MedDRA Preferred Terms in each language. Section 3 covers the pharmaceutical form, route of administration, and container type, and must use the EMA Standard Terms maintained by the EDQM. Terminology management that carries both MedDRA and the EMA Standard Terms is the operational foundation for SmPC translation.
Package leaflet: for patients
The package leaflet is the expert-to-layperson document. The patient has to understand it. Article 59 of the Directive defines the content. The EMA readability guideline applies. Centrally authorised products require user testing of the leaflet text. The most common failure mode is leaflet text written in the same medical register as the SmPC. Clinical accuracy survives; comprehension does not. The 2024 joint position paper from Medicines for Europe, EFPIA, and AESGP is the current industry reference on patient information shortcomings and is worth reading in full for any RA team building a readability programme.
Labelling: outer carton, immediate packaging, blister foil
Labelling sits under Article 54 of the Directive, with immediate-packaging rules in Article 55. Space is the operational constraint. Multilingual cartons are common in pharma, and the layout work that follows translation is artwork-aware. The EMA Standard Terms apply again. Member states each maintain a national blue box section for country-specific information, which the LSP needs to handle separately for each market.
| Pharma labelling and medical device labelling are different regimes The pharma label sits under Directive 2001/83/EC and the EMA QRD template. The medical device label sits under Regulation (EU) 2017/745 (the MDR) and Annex I Section 23. The two regimes share nothing but the word “label.” A pharma RA team that lifts a medical device translation supplier across to a pharma submission, or vice versa, will get review comments. For the medical device side, see the cluster piece on MDR translation requirements. |
Annex II: supply conditions and local representatives
Annex II is the EMA-specific section of the marketing authorisation. It covers the conditions of supply (prescription-only, restricted, or otherwise), the classification, and the list of local representatives by member state. The v10.4 update deleted “United Kingdom (Northern Ireland)” from the local representatives list, aligning with the Windsor Framework. For back-catalogue products, Annex II is often where the cleanup work happens during a variation cycle. The translation of Annex II changes follows the same QRD versioning as the leaflet and labelling.
How procedure type changes the language scope and workflow
Four EU procedure types apply to medicinal products: the centralised procedure (EMA-led), mutual recognition (MRP), decentralised (DCP), and the national procedure. Each carries a different language scope and uses a different template. The LSP needs to know which procedure a submission is using before scoping translation work, because that determines both the language matrix and (for MRP and DCP) which template version is the reference.
| Procedure | Regulator | Language scope | Template |
|---|---|---|---|
| Centralised | EMA + EC | All 24 EU official languages plus Norwegian and Icelandic (26 versions) | EMA QRD template (v10.4) |
| Mutual recognition (MRP) | Reference + concerned MS | Reference member state language plus each concerned member state language | CMDh annotated QRD for MRP/DCP |
| Decentralised (DCP) | Reference + concerned MS | Reference member state language plus each concerned member state language | CMDh annotated QRD for MRP/DCP |
| National | Single NCA | Official language(s) of the single member state | National variant of the QRD template |
| Variation (any procedure) | Follows parent procedure | Same language scope as the parent procedure | Same template as the parent procedure |
Centralised procedure: 26 language versions
The centralised procedure is the most demanding in language scope. All 24 EU official languages plus Norwegian and Icelandic. 26 language versions of the SmPC, PIL, and labelling per product, all required before the European Commission grants the marketing authorisation. The 25-day linguistic review covered in the next section is specific to this procedure. A multinational LSP with full coverage of the 26-language footprint is operating at scale on every centralised submission.
Mutual recognition and decentralised: CMDh templates
MRP and DCP are run by the Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh). The language scope is smaller: the reference member state language plus the official language of each concerned member state. The CMDh maintains its own annotated QRD template for these procedures (March 2024, with a correction in September 2025), distinct from the EMA centralised template. An LSP using the centralised template for an MRP submission will produce comments from the reference member state assessor. The template version control discipline applies here as well as in the centralised work.
National procedures: single member state
National procedures cover one member state at a time, with the language scope following that country. Often used for generics or for products with limited geographic distribution. Lower language complexity, but national agencies have their own local style and terminology preferences. Lægemiddelstyrelsen, BfArM, the MEB, the MPA, and ANSM each have their own review traditions, and an LSP that runs national-procedure work without local awareness will accumulate comments that a more attuned supplier avoids.
The EMA 25-day linguistic review timeline
The EMA linguistic review for centrally authorised products is a 25-day procedure that begins at the CHMP positive opinion.
The pressure points sit at Day 5 (the MAH submits annotated translations to national competent authorities via Eudralink) and Day 19 (the NCAs return reviewed files). Final translations are submitted on Day 25. The schedule is fixed. An LSP that has not been working ahead of the opinion cannot recover the timeline. The translation workstream that precedes the CHMP opinion – protocol, investigator brochure, informed consent forms, clinical study report – sits under a different regime and is covered in clinical trial translation.
| Day | What happens | Who is responsible | Translation workflow position |
|---|---|---|---|
| Day −180 to Day 0 | Rolling translation against draft SmPC and PIL versions | MAH + LSP | Glossary build, draft translations of all language versions, in-country reviewer set-up |
| Day 0 | CHMP issues positive opinion; annotated English product information is locked | CHMP | Final-version translation kick-off across all 26 language versions |
| Day 5 | MAH submits annotated translations of SmPC, PIL, and labelling to national competent authorities | MAH (via Eudralink) | All 26 language versions complete, reviewed, formatted, and submitted |
| Days 5 to 19 | National competent authorities review the translated documents (14 calendar days) | NCAs in each member state | LSP on standby for query response and revision turnaround |
| Day 19 | NCAs return reviewed files to the MAH with comments | NCAs | Comment-resolution and final revision cycle begins |
| Days 19 to 25 | MAH and LSP address comments; final translations finalised | MAH + LSP | Revision, retranslation where needed, in-country reviewer sign-off |
| Day 25 | Final translations submitted to the EMA | MAH (via Eudralink) | Submission complete; marketing authorisation can be granted |
What an MAH actually does between Day 0 and Day 25
The work does not start at Day 0. Sensible MAHs have the LSP running drafts against the rolling submission text from roughly Day −180 onwards. By Day 0, the SmPC and PIL are in their final reference form, the glossary is locked, and the 26 language versions are close to ready for final review. SmartDesk carries the per-project audit trail that NCA reviewers and EMA inspectors expect to see during and after the linguistic review. Project visibility for the MAH’s internal regulatory team sits in the same tool.
Common review comments and how to avoid them
Four review comments recur. SmPC inconsistency with the PIL: adverse reaction terminology or frequency descriptions differ between section 4.8 of the SmPC and section 4 of the PIL. Non-adapted medical language: PIL written in clinical register that a patient cannot parse. Structural deviations: mandatory QRD sections missing, headings reordered, warning boxes not reproduced. INN handling: International Nonproprietary Names not rendered correctly per the per-language INN list. Each of these is a workflow issue rather than a translator skill issue. Building the checks into the workflow up front, before Day 0, is straightforward. Catching them in the Day 19 to Day 25 window is hard.
The UK and the Windsor Framework
UK pharma operates under the MHRA, not the EMA. The Windsor Framework restructured how the UK handles labelling and packaging for medicines, replacing the dual-EU/UK approach with a single UK-wide marketing authorisation, a single UK-wide pack, and a “UK Only” labelling requirement. The translation implication is that UK is a separate workstream from the EU centralised procedure, with its own template handling and its own variation lifecycle.
What “UK Only” means in practice
Since 1 January 2025, all medicinal products on the UK market must carry a “UK Only” label on the outer packaging. The text must be at least 7-point font under Article 5 of EU Regulation 2023/1182, conspicuous, and clearly legible. There is no prescribed location. The MHRA permitted stickering as a transitional measure until 30 June 2025, after which direct printing onto packaging is required. The EU Falsified Medicines Directive is disapplied for UK packs. For multinational MAHs, the 2025 work was a stickering programme; from mid-2025 onwards, new launches go straight to direct print. The QRD template v10.4 reflects this by removing “United Kingdom (Northern Ireland)” from the list of local representatives in the package leaflet.
Why a UK programme is its own translation workstream
The UK leaflet is in English only, which makes the language scope small compared with a 26-language centralised submission. But the variation lifecycle is separate. Each EU variation that affects the leaflet or labelling needs the parallel UK variation, and MHRA timelines do not synchronise with EMA timelines. LSPs that treat the UK as “the English version we already have” miss UK-specific safety updates and Annex II changes.
| UK pharma is not EU pharma plus “UK Only” It is a separate marketing authorisation, run by the MHRA, on a separate variation track, with its own template handling. Plan the UK programme as a parallel workstream from the start of the marketing authorisation programme. |
Pharma translation vendor evaluation checklist
A pharma-ready translation supplier holds ISO 17100 and ISO 18587 certifications, has demonstrable Eudralink and EMA linguistic review experience, runs QRD-template-fluent terminology workflows with version tracking, supports in-country reviewers in final layout for carton artwork and PIL pagination, and produces a per-project audit trail. The checklist below lifts directly into a supplier RFP.
| Criterion | Why it matters for pharma packaging and PIL work | What to ask in the RFP |
|---|---|---|
| ISO 17100 | Process foundation for human translation | Please attach your current ISO 17100 certificate and certification body. |
| ISO 18587 | Required when MTPE is used | Do you hold ISO 18587 for any post-edited MT workflows? Please attach the certificate. |
| ISO 27001 | Information security for regulated content | Please confirm ISO 27001 certification and attach evidence. |
| QRD template fluency with version tracking | v10.4 is the current centralised template; v11 in consultation; CMDh has its own for MRP/DCP | Describe how you track QRD template versions and confirm which version is loaded into your current workflows. |
| EMA Standard Terms expertise | SmPC section 3 (pharmaceutical form, route, container) demands consistency | How do your linguists access and apply the EMA Standard Terms maintained by the EDQM? |
| INN handling | INN per language must follow the WHO INN list, not free translation | Describe your INN reference process for active substances. |
| MedDRA terminology | Adverse reactions in section 4.8 of the SmPC and section 4 of the PIL | How do you handle MedDRA Preferred Terms across all 26 EMA languages? |
| Eudralink submission experience | Day 5 submission tool for the MAH | Provide three examples of centralised procedure submissions where your translations were delivered into the Day 5 Eudralink workflow. |
| NCA review track record | Day 5 to Day 19 review by national authorities | Provide named examples of national competent authorities you have worked with and the volume of comments per submission. |
| Readability and user testing | Required for centrally authorised products | Describe your readability methodology and any user testing or bridging study support you provide. |
| Variation lifecycle and TM leverage | Variations recur; TM keeps cost and turnaround down | How do you maintain TM across variations for the same product, and what TM leverage do typical variations achieve? |
| In-layout artwork review | Carton artwork and PIL pagination require final-layout review | Can in-country reviewers edit translated content in final layout via your platform, without an InDesign licence? |
| Per-project audit trail | Evidence for EMA, NCA, and MHRA review | What per-project audit records do you produce, and for how long do you retain them? |
AdHoc holds current ISO 17100 and ISO 18587 certifications, with the certificates hosted on the AdHoc site for direct verification. SmartDesk carries the per-project audit trail that EMA linguistic review and MHRA inspections expect. SmartEdit lets in-country reviewers edit translated leaflets and cartons in final layout without an InDesign licence, which removes the licensing friction that slows the Day 5 deadline.
For the deeper read on the QA stack, see medical translation quality assurance. Where pharma content is delivered through digital channels – companion apps, electronic patient leaflets, connected dispensing systems – the software side of the translation work sits under medical software translation. Pharma promotional and educational content directed at healthcare professionals – sales aids, KOL slide decks, congress materials under the EFPIA Code, the ABPI Code 2024, and the relevant national codes – sits outside the marketing authorisation framework and is covered in HCP content translation.
Frequently asked questions
What is a package leaflet under EU law?
A package leaflet is the printed information document that accompanies every medicinal product authorised in the EU. It is the patient-facing companion to the Summary of Product Characteristics, governed by Articles 54 to 69 of Directive 2001/83/EC, and must appear in the official language or languages of every member state where the product is placed on the market.
How many EU languages are required for a centralised procedure submission?
Centralised procedure submissions require translation into all 24 EU official languages plus Norwegian and Icelandic, giving 26 language versions per product. Mutual recognition, decentralised, and national procedures need only the languages of the member states actually involved in the submission, which can be as few as one or two.
How long does the EMA linguistic review take?
Twenty-five calendar days. The clock starts on Day 0, the date of the CHMP positive opinion. The marketing authorisation holder submits annotated translations to national competent authorities via Eudralink by Day 5. The authorities return reviewed files by Day 19. Final translations are submitted to the EMA by Day 25.
Do I need a separate UK package leaflet after the Windsor Framework?
Yes. The UK operates under MHRA, not EMA. Since 1 January 2025, UK packs require a “UK Only” label, and the EU Falsified Medicines Directive does not apply. The QRD template v10.4 specifically deleted UK (Northern Ireland) from the local representatives section. The UK leaflet is its own variation workstream, on a separate MHRA timeline.
Speak with our localisation team
If your current translation supplier cannot answer the checklist questions with documented evidence, a structured supplier review is the next step. Speak with our localisation team about how AdHoc handles package leaflet, SmPC, and labelling translation for pharma manufacturers across the EU and the UK.
Sources
- EUR-Lex, Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use. https://eur-lex.europa.eu/eli/dir/2001/83/oj. Accessed 14 May 2026.
- EUR-Lex, Regulation (EC) No 726/2004 of 31 March 2004. https://eur-lex.europa.eu/eli/reg/2004/726/oj. Accessed 14 May 2026.
- European Medicines Agency, Product information (QRD) templates — Human (current version 10.4). https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/product-information-qrd-templates-human. Accessed 14 May 2026.
- European Medicines Agency, Draft QRD Human PI Annotated Template v11 (public consultation closed 31 August 2025). https://www.ema.europa.eu/en/documents/template-form/quality-review-documents-qrd-annotated-template-v11-draft-public-consultation_en.pdf
- CMDh, Annotated QRD template for MRP/DCP (March 2024, correction September 2025). https://www.hma.eu/human-medicines/cmdh/templates/qrd.html
- GOV.UK, Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework. https://www.gov.uk/government/publications/labelling-and-packaging-of-medicinal-products-for-human-use-following-agreement-of-the-windsor-framework
- EUR-Lex, Regulation (EU) 2023/1182, Article 5.
- Medicines for Europe, EFPIA, AESGP joint position paper on patient information on medicinal products (2024).
- ISO 17100:2015, Translation services — Requirements for translation services.
- ISO 18587:2017, Translation services — Post-editing of machine translation output — Requirements.