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Page Properties

ID

S37

Version

1.0.0

Type

Interoperability Standard

Status

Effective

Effective Date

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GPITF:Day One Effective Date
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Excerpt
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Supports electronic reporting of suspected adverse drug reactions (ADRs).

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Framework(s)

Table of Contents
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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

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

& DocumentationRequirements, implementation guidance and other documentation for this Information Standard Notice (ISN) are available at

ID

Requirement 

Level 

EYCR-001

Implement and maintain Electronic Yellow Card reporting inline with DCB1582: Electronic Yellow Card Reporting.

Status
colourRed
titleMUST

Compliance, Assurance & Testing

To achieve Electronic Yellow Care Reporting compliance, suppliers work closely with the programme to create and deploy test script scenarios to test whether the functionality has been implemented appropriately. The testing section within the requirements specification elaborates further on this.

  

For 

For advice, access to testing resources, and support

contact 

contact pharmacovigilance@mhra.gov.uk team. 

Roadmap

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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

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