Milestone’s guide on
Translating for EMA Approval
The Complete QRD Compliance Handbook for EU Submissions
A practical guide for Regulatory Affairs teams managing SmPC, PIL, and labelling translations under EMA’s QRD template.
Translation Requirements Under the QRD Template
The EMA QRD template defines mandatory structure, wording, and formatting for SmPCs, package leaflets, and labelling across all EU languages. Every translated version must match the approved English text exactly, follow the template line-by-line, and include all required statements without modification.
QRD compliance applies to all languages at submission. Template updates affect every language version simultaneously, and failure to apply the correct version leads to linguistic review findings and resubmission.
Authorities also assess terminology consistency across SmPC, PIL, and labelling, including the use of official medical terminology where required. Member States apply additional national requirements, such as blue box content and language-specific preferences, during linguistic review.
QRD-aligned translation is not optional. Errors identified during review directly impact approval timelines and market authorization.
What’s Included in this Handbook
QRD Template Requirements
Explains which documents must be translated, how the QRD templates control structure and content, and changes with template updates.
Translation Quality Standards
Covers MedDRA terminology rules, glossary creation, ISO-based quality expectations, and how regulators assess translation quality.
Managing Translations for EMA Timelines
Provides realistic timelines, change-management protocols, and preparation steps to meet Day 215 and Day 235 deadlines.
Country-Specific Considerations
Details blue box obligations, multilingual country rules, language variant restrictions, and Member State review priorities.
Handling Regulatory Feedback
Shows how to respond to translation-related comments during the 6-day post-review window, with severity-based response timelines.
Quality Standards By Milestone Localization You Can Trust
If you are looking for a reliable translation partner with expertise in regulatory knowledge to deliver submission-ready translations, look no further!
Milestone Localization is an ISO 17100:2015, ISO 13485:2016, and ISO 9001:2015 certified language service provider dedicated to the life sciences sector. We support pharmaceutical, biotech, and medical device companies with regulatory-grade translation and localization services designed to meet EMA and EU Member State requirements.
Our teams specialize in translating SmPCs, package leaflets, and labeling within QRD template constraints, strict timelines, and zero-tolerance quality environments.
We combine linguistic expertise with deep regulatory knowledge to deliver accurate, submission-ready content that withstands linguistic review and protects patient safety.
Triple-certified: ISO 17100:2015, ISO 13485:2016, and ISO 9001:2015
Three-stage quality assurance: Medical translator review, independent quality review, and regulatory specialist verification for every pharmaceutical translation
Globally accepted: Trusted by companies submitting to major regulatory authorities worldwide
Specialized translator network: Medical translators with a minimum 5 years’ experience in regulatory documentation and MedDRA terminology expertise
EMA timeline expertise: Proven track record managing Day 180-215 timelines and preventing Day 229 Member State comments
Download your free copy of the QRD Compliance Handbook
