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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.
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.
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
Submit requests for document revision if necessary.
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
Submissions to the European Medicines Agency
QRD (Quality Review of Documents) Process
submission dossier, and can hit the ground running as soon as you have the Agency's