Patient Information Leaflet Translation: MHRA and EMA Requirements

This article is for regulatory affairs teams, marketing authorisation holders and medical writers who need the patient information leaflet (PIL), also called the package leaflet, translated for the UK or EU markets. The PIL is the leaflet in the medicine pack that tells patients how to take the medicine safely.

It explains what the MHRA and the European Medicines Agency (EMA) require, how the EU linguistic review timetable works, and how to keep leaflets readable after translation. For medical devices, which follow different rules, see our guide to EU MDR language requirements.

What language must a patient information leaflet be in for the UK?

A patient information leaflet for a medicine sold in the UK must be in English. Regulation 266 of the Human Medicines Regulations 2012 states that information given under the labelling and leaflet rules "must be given in English", with narrow exceptions, for example for some orphan medicines and for products not intended to be delivered directly to the patient.

Other languages can be added, but only as exact equivalents. The MHRA's Best practice guidance on patient information leaflets puts it this way:

"Translations of the PIL into other languages in common use in the United Kingdom are permitted provided that the information presented is identical in all languages. Only the English-language leaflet will be subject to approval as part of the MA." (MHRA, Best practice guidance on patient information leaflets)

This has a practical consequence. A Polish or Welsh version of a UK leaflet is not separately approved, so the marketing authorisation holder is responsible for making sure it says exactly what the approved English text says.

Northern Ireland and shared packs

Since the Windsor Framework arrangements for medicines began on 1 January 2025, the MHRA's labelling and packaging guidance requires packs for the UK market to carry a "UK Only" label. It notes that shared inner components, "such as multi-lingual blister foils and joint leaflets may continue to be used" while UK and EU licences remain aligned.

What do EU rules require for package leaflets?

In the EU, Article 63(2) of Directive 2001/83/EC requires the package leaflet to be "clearly legible in an official language or official languages of the Member State where the medicinal product is placed on the market". Each Member State specifies which of its languages apply.

A leaflet may be printed in several languages, but the Directive adds a condition: "the same information is given in all the languages used". Multi-country packs therefore need perfectly aligned translations rather than versions adapted separately for each market.

How does EMA's linguistic review work for centrally authorised medicines?

For medicines authorised through the EU centralised procedure, EMA coordinates a linguistic review: national experts check every translation of the product information before the European Commission grants the licence. The process is set out in EMA's guidance on the linguistic review process of product information in the centralised procedure.

Five days is too short to translate a full summary of product characteristics, labelling and leaflet into every EU language from scratch. EMA advises applicants "to initiate the translation process well in advance of the opinion (e.g. after Day 180)". The same guidance warns that poor-quality translations or poor implementation of comments "may lead to a delay in transmission to EC".

What are QRD templates and why do translators need them?

QRD templates are EMA's standard templates for product information, including the summary of product characteristics and the package leaflet. EMA's Working Group on Quality Review of Documents develops, reviews and updates them. EMA's product information templates page publishes them in English and in 25 other languages.

Translators should start from the QRD template in the target language, not translate the headings themselves. The template fixes standard headings and statements that national reviewers expect to see worded in a set way. EMA also reminds companies that "It is the company's responsibility to ensure that the product information complies with all such requirements."

Does a translated leaflet need user testing?

User testing is a legal requirement for the leaflet itself, and translations must keep the readability the test proved. Regulation 260(3) of the Human Medicines Regulations 2012 says a package leaflet "must be legible, clear and easy to use" and that target patient groups must be consulted. Article 59(3) of Directive 2001/83/EC contains the EU equivalent.

The MHRA guidance notes that leaflet content "will need to be translated into colloquial English for the patient", meaning plain, everyday language rather than the technical wording of the summary of product characteristics. Translators into other languages face the same task: render "hypotension" as the everyday term for low blood pressure, and keep sentences short. Patient-facing register is a specialist skill, covered in our article on why medical translation needs subject-matter experts.

How to translate a patient information leaflet: step by step

1. Confirm the approved source. Translate the final approved English text, including any agreed changes from the assessment.
2. Load the target-language QRD template and any existing translations of earlier versions, so that unchanged text stays identical.
3. Translate in patient language. Use plain terms and the established lay vocabulary of the target country.
4. Review against the source with a second qualified linguist, checking doses, frequencies, units and warnings line by line.
5. Check consistency across the summary of product characteristics, outer carton, blister and leaflet, because reviewers compare them.
6. Proofread the typeset mock-up, including font size, headings and bullet structure.
7. Track and implement reviewer comments, recording a justification for any comment you do not accept.

Common mistakes in leaflet translation

• Starting after the opinion. In the centralised procedure, waiting until Day 210 leaves almost no time before the Day 215 deadline.
• Ignoring the QRD template wording. Paraphrased standard statements generate avoidable review comments.
• Making a "local" leaflet that differs from the approved text. UK and EU rules require the same information in every language used.
• Mixing professional and lay terminology. The leaflet must read as patient information, even when the summary of product characteristics uses technical terms.
• Relying on machine output for dosing text. See our article on machine translation in healthcare for the risks.

Leaflets are one part of a wider set of regulated medical texts. Our guide to medical and pharmaceutical translation explains how leaflet work fits with clinical trial and pharmacovigilance translation.

How TranslationWorks can help with leaflet translation

TranslationWorks is a UK-based translation agency that translates patient information leaflets, summaries of product characteristics and pack labelling with native-speaking professional linguists in more than 150 languages. Our medical and pharmaceutical translation service uses human translation with independent review, and can work from your QRD templates, glossaries and previous translations.

TranslationWorks holds ISO 17100, ISO 9001 and ISO 27001 registration and Cyber Essentials certification, so confidential product information is handled under audited processes. Tell us your languages and procedure timetable, and request a free quote for leaflet translation; we reply within 24 hours.