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Summary of Product Characteristics

The SmPC is part of the broader Product Information (PI), which also includes the Package Leaflet (PL) and names the authorization holder, as well as the conditions of the authorization. Accurate translation of drug instruction texts, especially those on vials, bottles, blister, and sachet, as well as Patient Information Leaflet (PIL), is important to pharmaceutical companies and patients. Translation errors must be critically avoided.

Submissions to the European Medicines Agency

The SmPC provides information on usage for healthcare professionals. It is an intrinsic part of the application for marketing authorisation of a new drug or medicine within the European Union before a medicinal product is authorized for sale. SmPC documents must be submitted to the European Medicines Agency or to the authorities of the member state in their respective languages.

EMA website provides guidelines for preparing the SmPC documents in each of the relevant languages. MedTrans provides translation services of SmPC documents in all of the official EU languages, as well as Icelandic and Norwegian languages.

QRD (Quality Review of Documents) Process

  • Prepare the SmPC documents.
  • Submit to the EMA.
  • Linguistic review by members of the QRD team of Member States (MS).
  • Check the translation by the EMA or its QRD representatives to determine if the content is acceptable.
  • Submit requests for document revision if necessary.

Features

  • High Quality-- Ensure the rigor and correctness of the translation.
  • Elite Translation-- Proficient translators and responsible proofreading
  • Proper Manuscript Management

MedTrans understands the intent and needs of the SmPC documents translation. We would like to help your teams produce quality documents from your clinical program to submission dossier, and can hit the ground running as soon as you have the Agency's approval.

Equivalent Services

United States Prescribing Information (USPI) Translation Services

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