Digital leaflets in Jordan

In August 2024 the Jordan Food and Drug Administration (JFDA) announced a new mandate requiring the implementation of an electronic pharmaceutical leaflet system for all registered pharmaceutical preparations. This system, which is based on XML HL7 FHIR Standards, specifically FHIR 5.0.0, will be linked to the Data Matrix two-dimensional code printed on the packaging material. The JFDA has set a strict deadline of January 17, 2025, for the re-registration of all products under these new guidelines.

Jordan FDA's Electronic Leaflet Requirements

The Jordan digital leaflets project by JFDA

Jordan facilitates the implementation of electronic leaflet by providing the industry with high-end services to make the process easier and simpler for them. MAH companies are requested to convert paper leaflets to electronic leaflets in XML format, the implementation of an electronic product information leaflet (ePI) is a mandatory requirement for all pharmaceutical products with a paper leaflet. Access to the digital leaflet is via an XML reader (a mobile application which can be downloaded for free from all App Stores), the reader processes the XML file and converts it into an HTML format for easy display.

Barcodes support

In Jordan, ePI is implemented using GS1 Data Matrix 2D Barcodes already present on the package. There is no requirement to print an additional QR Code on the outer package of the medicine but companies may decide to use one if they wish. The electronic leaflet is bridged (linked) to the Data Matrix Code via the mobile app.

How to comply to the JFDA electronic leaflets mandate

1. Ensure the latest leaflet versions for all pharmaceutical products are registered with the JFDA
2. Convert all PDF leaflets into XML and HTML5 formats with HL7 FHIR standards, maintaining 100% identical content between PDF and XML/HTML
3. Use the JFDA website to validate the XML and HTML5 files for each leaflet to ensure the files meet JFDA e-leaflet standards.
4. Submit validated files to the JFDA for approval.
5. Generate the link of the e-leaflets and encode it in a Datamatrix or QR code (optional). Embed the Datamatrix or QR code on the product artwork.

What is the acceptable file format of the ePI in Jordan?

The acceptable file format for ePI in Jordan is XML according ePI Type 1 specifications, which cover the Composition, Organization and Medicinal Product resources.

In order to ensure compliance with W3C HTML standards, JFDA have developed an HTML validation module to help build XML leaflets with valid HTML narrative. The file will be processed and validated, ensuring it complies with HTML standards and is properly rendered by the reader. To be acceptable by the Jordan Authority an ePI XML file must pass HTML validation.

What is ePi Type 1

ePI Type 1 is the minimum requirement for an ePI, enabling the recreation of existing label templates in a semi-structured format. It supports the creation of Healthcare Professional (HCP) labels, Patient Information Leaflets (PILs), or label text for artwork, such as EMA’s QRD template. Reproduces the local label template, including section headings, text, bullets, tables, and images, in a semi-structured format.

The Jordan ePI format

JFDA adopted the Vulcan's HL7 FHIR specifications for ePi Type 1 plus additional resources and HTML requirements (for display optimisation by the reader).

Limitations of the Jordan ePi format

• limited support for video and multi-media (Jordan-specific solution)
• limited positioning of multimedia objects in the narrative
• supports only 3 languages
• requires a dedicated app
• limited to medicines submission documents (PIL, SmPC).

Advantages of using the myHealthbox eLeaflet solution

• format independence (supports Jordan ePI specs and EMA ePI specs plus Japan XML, US-FDA XML, etc)
• new ePI versions supported as they come into focus (future proof compatibility)
• better multi-media support and security (our different approach to multi-media files allows full support for any media type and better security against data tampering and Unauthorized modifications)
• leaflets personalisation and support for advanced features (i.e. digital Adverse Reactions Form, dosage helpers, etc.)
• fully flexible media placement within sections for better readability and text flow.

myHealthbox support for JFDA ePI

Once leaflets information has been created or imported onto the myHealthbox eLeaflet platform they can then be exported to a number of different formats including ePI Type 1 compatible with the requirements of the Jordan FDA regulatory body.