If you work in pharmaceutical regulatory affairs or translation, you have almost certainly encountered the EMA QRD template. According to the European Medicines Agency, human medicines are currently authorised through the EU centralised procedure alone, each requiring compliant product information documents in multiple languages.
Getting the format right is not optional. Non-compliance can delay approvals, trigger regulatory queries, or result in outright rejection of your submission.
This guide explains what the QRD template is, how it applies to your SmPC and PIL documents, which version is currently in use, and how translation fits into the EU regulatory submission requirements.
Key Takeaways for EMA QRD Template
- The QRD template is mandatory for all human medicines submitted through EU regulatory procedures, including centralised, decentralised, and mutual recognition routes.
- It covers three core documents: the Summary of Product Characteristics (SmPC), the patient information leaflet format EMA, and labelling artwork.
- QRD template version 10.4 is the current published standard, though the EMA periodically releases draft updates, so always verify the latest version before starting a submission.
- The PIL must pass readability testing with real patients before approval, using the QRD-compliant structure as its base.
- After Brexit, MHRA submissions follow a separate but closely related UK framework, and UK-based sponsors working across both markets need to manage two parallel processes.
What Is the EMA QRD Template Used For?
The QRD template, short for Quality Review of Documents template, is a standardised formatting and content framework developed by the European Medicines Agency. It sets out how pharmaceutical companies must structure, write, and present their EMA product information template documents for human medicines submitted in the EU.
The template exists to create consistency across thousands of authorised medicines. Without it, SmPCs and PILs could vary widely in layout, terminology, and completeness, creating risks for both healthcare professionals and patients.
What Documents Does It Cover?
Three documents fall under the QRD framework:
- SmPC template requirements: The Summary of Product Characteristics is the authoritative product information document written for healthcare professionals. It covers indications, dosing, contraindications, side effects, and pharmacological properties.
- PIL template EMA: Also called the Package Leaflet, this is the patient-facing document included inside the medicine packaging. It must be written in plain language.
- Labelling artwork: Text on outer cartons and immediate packaging, including the “blue box” containing national-specific information required by individual EU member states.
What Is the Annotated Template?
The QRD annotated template human medicines accompanies each of these documents. It provides notes and explanations to help regulatory writers understand what each section requires and how to fill it in correctly. It is an essential working document alongside the blank template.
Which QRD Template Version Is Currently in Use?
The EMA updates its templates periodically to reflect changes in legislation, scientific guidance, and labelling standards. The current published standard is QRD template version 10.4. However, the EMA does release draft revisions for consultation before a new version is formally adopted.
At this point, version 10.4 remains the operative standard, but applicants should check the EMA website directly before beginning any new project, as a newer version may be in circulation or approaching adoption. Make sure the translation service UK follows the latest version.
Why Version Control Matters?
Using an outdated version is one of the most common causes of regulatory queries during assessment. It adds avoidable time and cost to your submission.
The EMA publishes all current QRD templates on its product information requirements page. Teams should check for updates at the start of each new project rather than assuming a previously used version remains current.
How Do You Format an SmPC Using the QRD Template?
The SmPC template requirements set out a fixed structure of numbered sections. Each section has a defined purpose, and the order cannot be changed. The pharmaceutical translation services have to ensure that it follows the structure well.
The Required Section Structure
The main sections of a QRD-compliant SmPC include:
- Name of the medicinal product
- Qualitative and quantitative composition
- Pharmaceutical form
- Clinical particulars (indications, dosage, contraindications, warnings, interactions, undesirable effects, overdose)
- Pharmacological properties
- Pharmaceutical particulars
- Marketing authorisation holder and number
- Date of first authorisation and renewal
- Date of revision of the text
The Role of Standard Phrases
The QRD template compliance framework also specifies the use of standard phrases: pre-approved, fixed-wording statements used in specific parts of the SmPC and PIL.
They cannot be paraphrased or reworded in the source document, and this is where many submissions run into trouble. Each phrase has an EMA-approved translation for every official EU language. Using a linguist’s own rendering, however accurate it appears, is a compliance failure.
Managing this correctly requires access to up-to-date EMA QRD template standard phrases databases across all 24 EU languages, and the regulatory awareness to apply them consistently on every project.
When Is the QRD Template Mandatory for EU Drug Submissions?
The QRD template is mandatory across all EU regulatory routes. There is no pathway to marketing authorisation for human medicines that bypasses it.
Procedures Where It Applies
It is required for:
- EMA centralised procedure submission, covering medicines approved for all EU member states simultaneously
- The decentralised procedure (DCP), where an application is submitted to multiple member states through a reference member state
- The mutual recognition procedure (MRP), where an existing national authorisation is extended to other EU member states
- National procedures, where individual member states apply QRD-aligned requirements
It Applies Throughout the Lifecycle
The QRD template does not just apply to the initial application. It continues through all subsequent variations and renewals. Any change to the product information, even a minor label update, must maintain full EMA QRD template compliance guide.
What Are the QRD Standard Phrases for Patient Information Leaflets?
The PIL template EMA provides includes mandatory headings and standard phrases that must appear in all patient-facing leaflets. These give patients consistent, clearly worded information regardless of which product they are reading about.
Required PIL Structure
Key structural headings of a QRD-compliant PIL include:
- What the medicine is and what it is used for
- What you need to know before you take it
- How to take it
- Possible side effects
- How to store it
- Contents of the pack and other information
Readability Testing Is Required
Beyond structure and standard phrases, the PIL must be written in plain language accessible to patients with varying levels of health literacy, and its translation can only be done by hiring professional translation services.
The EMA requires EMA QRD template readability testing to be conducted with real users before approval. This testing must show that patients can find information, understand it, and act on it correctly. The QRD-compliant structure forms the foundation for this process, and it must be completed for each language version of the PIL.
How Does the QRD Template Apply to MHRA Submissions After Brexit?
The UK’s exit from the EU created a fork in product information requirements that pharmaceutical companies cannot afford to ignore. The MHRA has built its own regulatory framework for product information, and while it shares the structural logic of the QRD template, it now operates as an entirely independent system with its own update cycle and submission requirements.
Managing Two Parallel Submissions
Companies seeking authorisation in both territories must now run two distinct product information tracks. MHRA templates govern UK submissions; the QRD template governs EU submissions. These are not interchangeable, and approvals in one jurisdiction carry no automatic effect on the other.
In practice, this means:
- UK submissions are governed by MHRA templates, which are related to but legally distinct from the EU product information template framework.
- Regulatory changes approved through the EMA process carry no automatic effect on MHRA-authorised products, and vice versa.
- Translation workflows must treat UK English and EU languages as separate deliverables.
- Clear document management processes are essential to prevent version confusion.
What This Means for UK-Based Teams?
UK-based pharmaceutical companies and their translators need to track both the QRD template and MHRA product information guidance as live, separate obligations, neither of which waits for the other to catch up.
Why Translation Is Central to QRD Template Compliance?
Any medicine approved through the EU centralised procedure is generally required to have its SmPC and PIL available across the official EU languages, which currently number 24. In practice, the exact language requirements depend on the member states concerned and the specific procedure used. Decentralised and mutual recognition applications require translations into the languages of each participating member state, which can vary by application.
What the Translation Must Preserve?
The translation process must maintain:
- The fixed section structure of the QRD template SmPC PIL labelling
- The approved standard phrases, using EMA-approved language only
- The plain language tone required for the PIL
- Precise clinical and pharmaceutical terminology throughout the SmPC
Why Specialist Translators Matter?
Errors in translation do not just create communication problems. A mistranslated dosing instruction, an altered standard phrase, or a structural deviation in the PIL can trigger a regulatory query or delay your route to market.
Working with professional medical translation services that understand the EMA QRD template standard phrases brings a level of regulatory awareness that general translators cannot replicate.
Practical Steps for QRD Template Compliance
Getting your SmPC and PIL submission right requires a structured approach. Here is the sequence that regulatory teams and their translation partners follow, drawn from EMA QRD template compliance guide standards:
- Download the current QRD template version directly from the EMA website before starting any project. Confirm you are using QRD template version 10.4 or the latest available.
- Use the annotated template alongside the blank version to understand section requirements and mandatory standard phrases.
- Draft the source SmPC and PIL in English following the template structure exactly. Do not deviate from section order, headings, or standard phrases.
- Conduct an internal review involving regulatory, medical, and pharmacovigilance teams before sending for translation. Commission translations from specialist services experienced in QRD template translation requirements EU. Brief translators on standard phrases and confirm they use EMA-approved translations.
- Carry out PIL readability testing with target users in the relevant language before submission.
- Submit via eCTD with all QRD-compliant documents included in Module 1 of your dossier.
- Track template updates and build a review cycle into your lifecycle management process.
Conclusion
EMA QRD template compliance is one of the foundational requirements of EU regulatory submissions for human medicines. It protects patients, ensures consistency across thousands of authorised products, and gives regulators a reliable framework for assessment.
For UK-based pharmaceutical companies, staying current with both EMA and MHRA EU regulatory submission requirements is an ongoing responsibility. Translation adds a significant layer of complexity, and errors at that stage can undo careful regulatory work done earlier in the process.
Working with translation services that understand the QRD framework from the inside makes compliance more reliable and timelines more predictable.
Frequently Asked Questions
Does the QRD template apply to generic medicine submissions as well as new medicines?
Yes. The QRD template applies to all human medicinal products regardless of whether the application is for a new active substance, a generic, a hybrid, or a biosimilar. The same SmPC and PIL format requirements apply across all application types.
Can you submit the SmPC or PIL in English only for a centralised procedure?
No. Under the EU centralised procedure, the approved SmPC and PIL are required across the official EU languages, currently 24 in total. However, the precise languages required can depend on the scope of the authorisation and the member states included. The English version forms the reference document, but all required language versions must be QRD-compliant and submitted as part of the authorisation package.
Who is responsible for ensuring QRD template compliance in a submission?
The marketing authorisation holder (MAH) carries responsibility for QRD compliance. In practice, this is often managed by the regulatory affairs team in collaboration with medical writers and translation partners. Errors in any language version remain the MAH’s responsibility.
How often does the EMA update the QRD template?
The EMA reviews and updates the QRD template periodically, but there is no fixed schedule. Changes in EU pharmaceutical legislation, new scientific guidance, or feedback from regulatory experience can trigger updates. It is the applicant’s responsibility to use the most current version at the time of submission.
What happens if a PIL fails readability testing?
If a PIL fails readability testing, the applicant must revise the document and retest. The EMA expects evidence of a satisfactory readability test before approving. Failing to conduct testing at all or submitting a PIL that has not passed will delay the authorisation process.
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