Insights

In July 2026, the European Medicines Agency (EMA) updated two documents concerning the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD), also known as the Article 57 database: the guidance on coding authorised indications, dated 2 July 2026, and the XEVMPD user manual, dated 6 July 2026.

XEVMPD contains structured information on medicinal products and substances authorized or under development in the European Union and European Economic Area. The revised guidance clarifies how Marketing Authorisation Holders should represent the therapeutic indications included in section 4.1 of the Summary of Product Characteristics (SmPCs) using MedDRA terminology.

This update supports more consistent medicinal product information within the European regulatory and pharmacovigilance environment and facilitates the future migration of XEVMPD data towards the ISO IDMP-based structure used in the Product Management Service (PMS).

Although the revision does not introduce new requirements for safety reports or signal management, standardized XEVMPD product information supports the recoding of Individual Case Safety Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) in EudraVigilance. The XEVMPD user manual also highlights the importance of standardizing potentially vague medicinal product information from spontaneous adverse reaction reports to allow accurate data analysis by scientific experts.

Key changes at a glance

• Use of LLTs and PTs

Since January 2026, indications may be coded using the most suitable MedDRA Low Level Term (LLT) or Preferred Term (PT). LLTs and PTs may be used within the same medicinal product entry, and more than one LLT may be selected where necessary to fully represent an indication.

• Source of indication coding and national differences

MedDRA coding must be based on section 4.1 of the SmPC authorised by the relevant Member State. Other sections of the SmPC may be consulted to understand the clinical context, but information not included in section 4.1 should not be added as a separate indication. National differences must be reflected in the submitted data.

• Indications and comorbidities

MedDRA coding should capture the disease, symptom or procedure for which the medicinal product is authorised. Other conditions mentioned in section 4.1 that only define the patient population, without being the target of treatment, should not be captured. For example, where a medicinal product is authorised to treat pancreatic insufficiency in patients with cystic fibrosis, only pancreatic insufficiency should be coded as the indication, since cystic fibrosis defines the patient population rather than the condition targeted by the treatment.

• Specificity without overcoding

The selected MedDRA term should be as specific as possible and capture the most detailed information contained in the authorised indication, without including synonymous terms or every medical concept that could potentially be covered by the indication.

• Treatment, prevention and prophylaxis

Where both treatment and prevention or prophylaxis are authorised, both purposes should be represented. Where no relevant combined MedDRA term can be identified, the disease or event should be coded together with a separate term for prophylaxis or prevention, as appropriate.

Implications for Marketing Authorisation Holders

Marketing Authorisation Holders should base coding on the applicable national section 4.1 wording and select the most suitable LLTs or PTs, ensuring the highest possible specificity.

Companies may consequently consider whether their procedures, system configurations and training materials remain aligned with these principles, particularly regarding LLT and PT coding, national differences and the distinction between the indication and comorbidities or concurrent conditions.

RPN is available to provide support with XEVMPD data maintenance, MedDRA coding, procedural documentation and training related to medicinal product data.