𝘈𝘱𝘱𝘳𝘰𝘹 𝘳𝘦𝘢𝘥 𝘵𝘪𝘮𝘦: 4 𝘮𝘪𝘯𝘴🕒
From the readability of Patient Information Leaflets (PILs) to language accessibility in consent forms, the MHRA has clear expectations for how and when translation must be used. And with changes brought about by the Windsor Framework and Brexit, those expectations are shifting.
In this article, we’ll break down what the MHRA actually says about life sciences translation, and what that means for life sciences brands operating in or targeting the UK.
Translation requirements for Patient Information Leaflets (PILs)
The MHRA expects PILs to be “easy to understand” for the average patient. That includes not only the accuracy of the information but also the clarity of the language itself.
In the UK, English is the default, but that doesn’t mean you can ignore multilingual audiences.
According to official MHRA guidance on medicines packaging and labelling, PILs should be carefully written, clearly formatted and, where necessary, adapted for non-English speakers, particularly in multilingual communities or where language may be a barrier to compliance or safety.
Guidelines pre-January 2025 permitted joint multilingual packaging; however, UK-specific materials are now required.
This has major implications for translation workflows: companies relying on shared packs must begin transitioning now to ensure MHRA compliance by the deadline.
Clinical trials: When translation is mandatory
When running clinical trials in the UK, it’s not enough to provide participant materials in English.
If the participant population includes individuals who aren’t fluent, translated consent forms and patient information sheets are expected.
The MHRA makes this clear in its official FAQs for Investigator Sites, stating that documents must be translated into a language the participant understands. Failing to do so can compromise the legal validity of consent, not to mention patient safety.
At Wolfestone, we routinely support sponsors, CROs and site teams with linguistic validation and translation for clinical trial documentation, helping them navigate MHRA expectations while maintaining study timelines.
Post-market communications: reaching patients in their language
Translation plays a role in post-market surveillance too.
Take the MHRA’s Yellow Card Scheme, for example. Patients are encouraged to report side effects and adverse events through this system. And, while the form is provided in English, the MHRA acknowledges the need for language access, offering machine translation via browser tools to support multilingual submissions.
While not formal translation, it reflects a recognition that linguistic accessibility can’t be an afterthought in pharmacovigilance.
The Windsor Framework and the end of shared packs
A key driver of change is the MHRA’s implementation of the Windsor Framework, which separates regulatory treatment between Great Britain and Northern Ireland.
From 2025, EU-approved joint labelling will no longer be acceptable for GB markets. That means companies must localise their labelling and PILs specifically for the UK, and that includes translation where applicable.
If you’ve previously relied on centralised EU packs to cut costs, this change could impact your workflows but it also presents an opportunity to improve UK-specific readability and compliance.
Translation touchpoints in the regulatory journey
Translation and localisation are also highly likely to be relevant during your regulatory submission process.
According to the MHRA’s Scientific Advice guidance, materials like mock-ups and draft packaging can be reviewed in early-stage advice, meaning translated content could be subject to scrutiny before your product even hits the market.
Commonly translated materials include:
- Clinical trial protocols
- Informed consent forms
- Patient information
- Labels
- Packaging
- Safety reports
- Product compositions
- And more.
What this means for life sciences brands
Our advice would be not to treat translation as a box-ticking exercise. Instead, translation and localisation in life sciences need to be treated as a quality, compliance and safety imperative.
This isn't just our advice, it's the MHRA's guidelines.
We help life sciences clients:
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Translate PILs and patient materials with clarity and accuracy
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Localise packaging to meet UK-specific regulations
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Translate and validate informed consent forms
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Support multilingual trials with certified, ISO 17100-compliant processes
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Navigate evolving MHRA expectations around language, accessibility and risk
Our team of medical linguists, project managers and QA specialists can help you stay compliant, without delaying your go-to-market plans.
Contact us today for a free consultation, quote, or to request a test translation.
𝘒𝘦𝘪𝘳𝘢𝘯 𝘩𝘢𝘴 𝘣𝘦𝘦𝘯 𝘸𝘳𝘪𝘵𝘪𝘯𝘨 𝘢𝘣𝘰𝘶𝘵 𝘭𝘢𝘯𝘨𝘶𝘢𝘨𝘦 𝘴𝘰𝘭𝘶𝘵𝘪𝘰𝘯𝘴 𝘴𝘪𝘯𝘤𝘦 2021 𝘢𝘯𝘥 𝘪𝘴 𝘤𝘰𝘮𝘮𝘪𝘵𝘵𝘦𝘥 𝘵𝘰 𝘩𝘦𝘭𝘱𝘪𝘯𝘨 𝘣𝘳𝘢𝘯𝘥𝘴 𝘨𝘰 𝘨𝘭𝘰𝘣𝘢𝘭 𝘢𝘯𝘥 𝘮𝘢𝘳𝘬𝘦𝘵 𝘴𝘮𝘢𝘳𝘵. 𝘏𝘦 𝘪𝘴 𝘯𝘰𝘸 𝘵𝘩𝘦 𝘏𝘦𝘢𝘥 𝘰𝘧 𝘔𝘢𝘳𝘬𝘦𝘵𝘪𝘯𝘨 𝘢𝘯𝘥 𝘰𝘷𝘦𝘳𝘴𝘦𝘦𝘴 𝘢𝘭𝘭 𝘰𝘧 𝘰𝘶𝘳 𝘤𝘰𝘯𝘵𝘦𝘯𝘵 𝘵𝘰 𝘦𝘯𝘴𝘶𝘳𝘦 𝘸𝘦 𝘱𝘳𝘰𝘷𝘪𝘥𝘦 𝘷𝘢𝘭𝘶𝘢𝘣𝘭𝘦, 𝘶𝘴𝘦𝘧𝘶𝘭 𝘤𝘰𝘯𝘵𝘦𝘯𝘵 𝘵𝘰 𝘢𝘶𝘥𝘪𝘦𝘯𝘤𝘦𝘴.
