Product Information Translation

Product Information (PI) is an intrinsic part of the application for marketing authorization of a new drug or medicine. In the European Union, it includes the Summary of Product Characteristics (SmPC) and the Package Leaflet (PL); it names the authorization holder and sets out the conditions of the authorization. The equivalent of the SmPC in the United States is the United States Prescribing Information (USPI). MedTrans provides PI translation service that includes translation into 24 EU and European Economic Area (EEA) languages. A linguistic review of product information in all EU languages is performed after adopting CHMP Opinions to ensure high quality and consistent product information of Centrally Authorised Products (CAPs) in all Member States.

PI Documents Requirements
  • Development of Core Data Sheet
  • Development of local labels/Harmonisation text
  • Readability testing
  • Translations
  • Implement PI changes

Performed by experienced translators.
Optimized texts for readability, translatability and artwork.
Proofreading and linguistic review.
Align PI documents with core data sheets (CCDS) and company core safety information (CCSI).

  • 24/7 Services

    24/7 Services

  • Reduce Overhead Costs

    Reduce Overhead Costs

  • All File Types Supported

    All File Types Supported

In the EU, regulatory support provided by MedTrans include:
  • SmPC
  • Package Leaflets (PL)
  • Decentralised Procedures (DCP)
  • Mutual Recognition Procedures (MRP)
  • Labeling Documents
Quality Control System

MedTrans supports an extensive array of activities relevant to generating documents to comply with the Quality Review of Documents (QRD) and Product Information Quality (PIQ) standards.

Ensure the translated or proofed materials meet the requirements of regulatory bodies, including the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines (EDQM), the EU pharmacopeia, the World Health Organization (WHO).

Why Choose Us?

MedTrans understands the intent and needs of the PI and can help your teams produce a translated document that is a consistent reflection of the data available from your clinical program and submission dossier. Our service ensures that PI documents in the product dossier are compliant with regulatory guidelines and ready for submission to health authorities (HA) within the marketing authorization application (MAA) and post‑approval procedures.

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