The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information (ePI) on medicines in the European Union (EU).

The product information (PI) of a medicine includes the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals. These documents are required when a medicine is authorised in the EU, as they explain how such medicine should be used and prescribed to patients. They also play a key role in informed decision-making at each stage of treatment. The EU ePI Common Standard is a step towards improved delivery of information on medicines to healthcare professionals, patients and consumers.

One of the key advantages of ePI is that it can be updated immediately, as soon as new information becomes available. The structured nature of ePI also offers an opportunity to customise the product information to individual needs and to make it more easily accessible to users with diverse abilities. Future developments of the ePI could include functionalities such as automatic update notifications, access to supportive multimedia content and online adverse-reaction reporting tools.

KONTEKST is a specialist provider of translation services for contract research organisations and pharmaceutical companies. We offer translations of documents from the regulatory area, which are made with reference to the intended use of the material and the target audience. The documents translated by us are subject to quality control, revision for accuracy, and their formatting reflects the formatting of the source documents.

The documentation we translate includes but is not limited to:

  • correspondence with regulatory bodies and Ethics Committees
  • clinical trial authorizations
  • medicinal product/medical device authorisation documentation
  • documentation related to variations to the terms of a marketing authorisation
  • package leaflets
  • Summary of Product Characteristics
  • package labelling.