Electronic Yellow Card Reporting
ID | S37 |
Version | 1.0.1 |
Type | Standard |
Status | Effective |
Effective Date | Dec 4, 2025 |
Contracting Vehicle(s) |
Introduction
The Medicines and Healthcare products Regulatory Agency (MHRA) collects reports of suspected adverse drug reactions (ADRs) via the Yellow Card Scheme. These provide a source of information on potential drug safety issues allowing the agency to take regulatory action to protect public health. Healthcare professionals report ADRs either by completing a paper form or a form on an external website/App.
The Information Standard Notice (ISN) for Electronic Yellow Card reporting defines a method for submitting the information electronically; this allows IT systems to reduce the burden on the clinician by populating the majority of the Yellow Card submission from the patient's electronic record.
Requirements
ID | Requirement | Level |
EYCR-001 | Implement and maintain Electronic Yellow Card reporting inline with DCB1582: Electronic Yellow Card Reporting. | MUST |
Compliance, Assurance & Testing
See the Electronic Yellow Card Reporting section on Onboarding Overview of the Digital Care Services Interoperability Standards and Requirements.
Dependencies
There may be dependencies for implementing this Standard, however, there are no Interoperability Standards within the Capabilities and Standards model that are dependents.
Roadmap
Items on the Roadmap which impact or relate to this Standard