Project 1: Certified Translation of Patient Leaflets with Legal Validation
Client Needs in the Pharmaceutical Sector
To legally market and distribute imported medicines, Farmed S.r.l. must provide certified Italian translations of the following regulatory documents to AIFA:
> Summary of Product Characteristics (SmPC)
> Patient Information Leaflet (PIL)
> Labels
These translations must be accurate, complete, and fully compliant with EU-approved texts. The applicant is required to submit the translated files within 7 days of receiving notification of procedure closure from the relevant Member State.
Our Certified Language and Compliance Solution
Since 2018, Translation-IN has managed 62 translation projects of this type, translating over 7,000 patient leaflets, totaling more than 2 million certified words in all 24 official languages of the European Union.
Languages Covered
EMA regulations require that leaflets and SmPCs for centrally approved medicines be translated into the 24 official EU languages:
> Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish.
Certified Accuracy and Compliance
Each translation is delivered with a Certificate of Accuracy, confirming the faithful reproduction of the original content, signed and stamped by our agency.
All translations adhere to strict regulatory standards, ensuring clear, compliant information is available to healthcare professionals and patients alike.
Managing Urgency in Regulatory Translations
Pharmaceutical translation services are inherently urgent and time-critical.
Parallel drug importation is tightly regulated. Each phase must meet fixed deadlines to secure marketing authorization. For Farmed, speed and accuracy in certified translations are essential to regulatory success and product availability on the Italian market.
1. AIFA-Imposed Submission Deadlines
To obtain approval from AIFA, all documentation must be submitted quickly and with absolute accuracy. Delays in translating patient leaflets or labels may delay approval and market entry.
2. Updates and Document Revisions
AIFA may request corrections or additions to submitted materials. In these cases, revised translations must be delivered immediately to avoid rejection or delays in product release.
3. Pharmaceutical Distribution Timelines
After authorization, medications must be swiftly distributed to pharmacies, hospitals, and wholesalers. Translation delays may disrupt the supply chain and hinder patient access.
4. Market-Driven Product Availability
Parallel importation depends on availability in foreign markets. When new stock becomes available, Farmed must act fast—making translations a mission-critical step.
5. Simultaneous Project Management
Farmed often manages multiple pharmaceutical products simultaneously, each with different regulatory timelines. This creates overlapping translation demands with tight delivery expectations.
Conclusion
Our work with Farmed demonstrates the need for fast, accurate, and fully compliant certified translations to meet strict regulatory deadlines, ensure uninterrupted supply, and respond to AIFA's evolving requirements.
We’ve handled a variety of content formats—including printed leaflets—and applied meticulous quality control to guarantee accuracy and full compliance with Italian and European regulations.
