ePI: electronic product information
Electronic product information (ePI) is the SmPC, leaflet and labelling published as structured data to a common EU standard instead of a static file.
The EU ePI Common Standard, agreed by EMA, the Heads of Medicines Agencies and the European Commission, uses HL7 FHIR so the same content can be reused across systems and read on any device. Under current law the paper leaflet in the pack remains mandatory, and ePI is generated from the approved product information rather than authorised as a separate text.
Problems usually start with the source documents: inconsistent headings, unmanaged versions across markets, and labelling changes that are not carried through to the electronic version.
Under the new pharma package (not yet in force), the leaflet must be provided on paper and electronically, and Member States may allow electronic-only leaflets; see ePI changes.
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Regulatory and labelling teams plan the ePI transition and check labelling against approved text in the ePI and labelling workflow.
Related terms
- eCTD: electronic Common Technical DocumentThe electronic Common Technical Document (eCTD) is the electronic format for regulatory dossiers, organised in the five-module structure defined by ICH M4.
- Type IB variation: minor change notified before implementationA Type IB variation is a minor change that is neither Type IA nor Type II and must be notified to the authority before it is implemented.
- SmPC: summary of product characteristicsThe summary of product characteristics (SmPC) is the approved document that tells healthcare professionals how to use a medicine safely and effectively.
- Package leaflet: patient information leaflet in the packThe package leaflet is the patient-facing text in every medicine pack, required by Articles 58 and 59 of Directive 2001/83/EC and based on the SmPC.
- QRD template: EMA template for product informationThe QRD template is EMA's standard layout for the SmPC, Annex II, labelling and package leaflet, with fixed headings and statements in every EU language.
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