Patient Information Leaflet Translation (UK)

Whether it’s for a licensed medicine, a medical device, or an over-the-counter product, a Patient Information Leaflet (PIL) plays a crucial role in ensuring patients understand how to use your product safely and effectively. But when your audience speaks multiple languages, getting your leaflet professionally translated isn’t just a courtesy… it’s a regulatory and ethical necessity.

At Tongue Tied, we’ve translated thousands of PILs into 200+ languages over the past 30 years, helping organisations meet MHRA standards and improve patient outcomes across the UK and beyond.

What Is a Patient Information Leaflet?

A Patient Information Leaflet (PIL) is a document supplied with a medicine or medical device that provides essential instructions, warnings, and usage guidance for patients. It complements the Summary of Product Characteristics (SmPC) but is written in plain, accessible language for non-specialists.

A PIL typically includes:

• What the medicine or device is used for

• Possible side effects

• How to take or use the product

• Warnings and precautions

• Storage information

In the UK, PILs are required by the MHRA and are often reviewed during product licensing, regulatory audits, and ethical submissions. For multilingual patient populations — particularly in NHS contexts — having accurate, culturally appropriate translations is essential.

Why Professional Translation Is Essential in the UK

⚠️ Legal and Regulatory Risk

The MHRA, NHS trusts, and other bodies consistently warn against using automated translation tools like Google Translate for medical materials. According to MHRA overlabelling guidance (2024), translated PILs must be:

• Accurate

• Consistent with the original English version

• Clear and comprehensible to patients

Failure to comply can lead to:

• Regulatory delays or product rejections

• Legal liability if patients misuse a product based on poor translations

• Damaged trust with patients and providers

  
  

🏥 NHS Expectations

Many NHS trusts require PILs to be available in top local languages, such as Urdu, Polish, Bengali, Arabic, or Somali. However, some trusts still rely on volunteer or non-certified translations and this is increasingly being flagged as a risk.

Professional PIL translation provides:

• Legally defensible quality

• Consistent terminology across updates

• Readability aligned with NHS literacy standards

  
  

The Unique Challenges of Translating PILs

Translating a PIL isn’t as simple as swapping out words. These documents are governed by layers of regulatory, linguistic, and formatting requirements.

✍️ Medical & Legal Terminology

Even “plain English” PILs contain complex terms related to dosage, adverse effects, or medical devices. Misinterpretation can lead to serious misuse or non-compliance.

📄 Complex Layouts

Many PILs use:

• Small fonts

• Tables

• Side-by-side instructions and warnings

  
  

These require precise formatting in multilingual versions to maintain clarity and alignment with packaging.

🌍 Cultural Sensitivity

Terms that seem neutral in English may be misunderstood or offensive in other languages. Literal translations often fail to convey meaning appropriately.

🔄 Version Control

As products evolve, PILs are updated. Without proper translation memory and document management, older translations may become outdated or inconsistent with the current product.

Our Proven Translation Workflow (UK‑Compliant)

At Tongue Tied, we’ve built a system specifically for regulated healthcare materials, with PILs being one of the most common requests.

1. Document & Regulatory Review

We first assess:

• Whether the PIL will be used in MHRA submissions or overlabelled unlicensed imports

• The number of languages and format requirements (e.g. bilingual layouts, PDFs)

  
  

2. Terminology Setup

We build glossaries aligned with:

• MHRA templates and phrasing

• Your SmPC and product documentation

• Patient-friendly language suitable for NHS standards

  
  

3. Translation Memory

We use translation memory software to detect repeated segments, saving you time and money, especially useful for common sections like “How to take this medicine” or “Possible side effects”.

You don’t pay to retranslate what’s already been approved.

4. Specialist Medical Linguists

Your translation is handled by professionals with:

• Medical, pharmaceutical, or life sciences backgrounds

• Experience with NHS and MHRA-compliant language

• Fluency in both medical terminology and plain language adaptation

  
  

5. Layout and Formatting (DTP)

If needed, we reformat multilingual leaflets to:

• Match your existing template

• Ensure readability and alignment

• Produce bilingual layouts or NHS leaflet styles

  
  

6. ISO-Certified Editing & QA

All projects go through ISO 17100 certified quality assurance, which includes:

• Second linguist review

• Spelling, grammar, and regulatory phrasing checks

• Alignment with your brand voice and layout

  
  

Example: NHS Leaflet Translation Done Right

A Midlands-based NHS trust asked us to retranslate their patient leaflets after an audit revealed inconsistencies in the Urdu and Polish versions previously created using automated tools.

We:

• Created an approved glossary for key terms

• Translated into 7 languages

• Reformatted the layout into NHS-compliant bilingual A5 leaflets

• Delivered within 5 days

  
  

The trust now uses our team for regular updates and additions, ensuring ongoing compliance and patient clarity.

What Languages Do We Cover?

We support all NHS-priority languages, including:

• Urdu

• Polish

• Bengali

• Arabic

• Somali

• Romanian

• Punjabi

• Chinese (Simplified and Traditional)

• Gujarati

• Welsh

Need others? Just ask. We work with native-speaking linguists in over 200 languages.

Benefits of Choosing Tongue Tied

• ✅ Regulatory confidence – every word checked against MHRA expectations

• ✅ Cost-effective updates – pay only for new content, not repeats

• ✅ Flexible formats – bilingual leaflets, multilingual PDF bundles, or XML-ready files

• ✅ Fast turnaround – often within 2–3 working days

• ✅ No hidden fees – transparent quoting and rapid responses

Turnaround & Pricing

Document	Standard Turnaround
1–2 page PIL (single language)	2–3 working days
Multilingual PIL (5+ languages)	4–5 working days
Urgent translation	Same/next day available

We provide fixed quotes upfront — no hidden charges, rush surcharges, or formatting extras. And you’ll always speak to a human, not a chatbot.

FAQs

Can’t we just use Google Translate for PILs? No. This is explicitly discouraged by MHRA and the NHS. Even small mistakes in medical terms can lead to misuse, complaints, or liability.

Are translated PILs legally binding? Yes, especially if submitted to regulators or distributed to patients. That’s why professional accuracy is critical.

Do you support bilingual or side-by-side formats? Yes. We can match NHS-style bilingual layouts or format to your existing leaflet template.

How often should translations be reviewed or updated? We recommend reviewing every 2–3 years or whenever the source content changes, in line with NHS and PQAC standards.

Do you translate Braille or audio leaflets too? Yes, upon request. We work with accessible formats as needed.

Let’s Help You Get It Right — The First Time

Whether you’re preparing a new product submission, relabelling an imported medicine, or updating your NHS library, professionally translated PILs are a must.

We’ll make sure your leaflets are:

• Clear and culturally appropriate

• Compliant with UK regulations

• Delivered quickly and cost-effectively

  
  

📧 Email: sales@ttmltd.com

📞 Phone: +44 1606 352 527

🔗 Connect with Richard on LinkedIn for tailored advice