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Electronic Yellow Card Reporting

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Information Standard Notice

Acting under delegated authority from the Secretary of State for Health, the Data Coordination Board has approved a change to an existing information standard for publication under section 250 of the Health and Social Care Act 2012.

Important: Full conformance date

You must comply with this change by the full conformance date: 1 December 2018

Standard definition

Unique identifier

DCB1582 Amd 16/2017

Name
Electronic Yellow Card Reporting
Publication version
3.0.0
Approval date
12 October 2017
Publication date
26 October 2017
Documentation
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Standard definition

Description
Defines a method for data submission about suspected adverse drug reactions via the Yellow Card Scheme by populating the majority of the Yellow Card submission from the patient's electronic record.

About this change

Scope
NHS Services
Applies to
  • General Practices MUST follow this standard
  • Other NHS providers, for example: acute trusts, community trusts and pharmacies MAY follow this standard
Impacts upon
Implementation of this information standard impacts all health IT systems suppliers providing Yellow Card functionality in systems to the above providers; suppliers should work with their customers to determine necessary changes. Note that as part of the requirements under the NHS GP Systems of Choice Programme (GPSoC), all suppliers of primary care systems must integrate electronic Yellow Card facilities into their clinical software.
Link to further information
Further information

Contacts

Sponsor

John Quinn, Medicines and Healthcare products Regulatory Agency

SRO
Mick Foy, Medicines and Healthcare products Regulatory Agency
Business Lead
Rebecca Owen, Medicines and Healthcare products Regulatory Agency
Help Desk

pharmacovigilance@mhra.gov.uk

Dates

Implementation Date
1 February 2018
Full Conformance Date
1 December 2018
Post Implementation Review date
1 December 2019