Reporting requirements for medicine shortages and discontinuations
Guidelines to help mitigate and manage medicine shortages.
Documents
Details
This guidance is for medicines marketing authorisation holders (MAHs). It gives them an overview of how to report medicines shortages to the Department of Health and Social Care (DHSC) under the January 2019 regulations.
MAHs should report supply issues, including potential shortages and discontinuations, to DHSC via the discontinuations and shortages (DaSH) portal.
The document ‘DHSC reporting requirements for medicine shortages and discontinuations’ replaces the best practice guidelines that were published in 2007.
The DaSH portal MAH administrator and user manuals have been updated to include instructions on how to use the new archive function and how to view the new notifications function within the DaSH system.
Setting up administrators on the DaSH portal
- Complete the ‘Discontinuations and shortages (DaSH) portal MAH and administrator set-up form’ (above) with details of MAH-nominated DaSH portal users.
- Email your completed form to dash@dhsc.gov.uk.
If you cannot access the DaSH portal, contact the Medicine Supply Team at dash@dhsc.gov.uk.
Video guidance
You can watch these video guides on how to use the DaSH portal.
DaSH portal: registration
DaSH portal: password reset
DaSH portal: navigation overview
DaSH portal: navigation overview
DaSH portal: navigation overview (admin)
DaSH portal: navigation overview admin
DaSH portal: reporting a shortage
DaSH portal: reporting a shortage
DaSH portal: reporting a discontinuation
DaSH portal: reporting a discontinuation
DaSH portal: creating and responding to actions
DaSH portal: creating and responding to actions
DaSH portal: action notes and documents
DaSH portal: action notes and documents
DaSH portal: amending company details
DaSH portal: amend company details
DaSH portal: user management
DaSH portal: archiving
Contacts
If you have any questions about ensuring the flow of medical supplies into the UK, you can contact the relevant government team for your sector:
- Medicines contingency (for EoTP-related returns or queries): medicinescontingencyplanning@dhsc.gov.uk
- Medicine shortages or discontinuations reporting: dash@dhsc.gov.uk
- Medical Devices and Clinical Consumables (MDCC) contingency team: medtech-communications@dhsc.gov.uk
- Clinical trials: ctcontingencyplanning@dhsc.gov.uk
- Vaccines and countermeasures: immunisation-mb@dhsc.gov.uk
- Blood and transplants: transplants@dhsc.gov.uk
- Non-clinical goods and services: nhsi.eucpc@nhs.net
Last updated 4 September 2023 + show all updates
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Updated the 'Medical Devices and Clinical Consumables (MDCC) contingency team' contact email address to medtech-communications@dhsc.gov.uk.
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Updated administrator and user manuals to include instructions on: viewing a list of shortages and searching; reporting a shortage as back in stock; viewing a list of discontinuations and searching.
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Updated the DaSH portal marketing authorisation holder (MAH) administrator and user manuals to include instructions on how to view the new notifications function within the DaSH system.
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Added latest DaSH portal MAH administrator and user manuals which include instructions on new archive function, and also a new video on archiving.
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Updated guidance to clarify the obligations on UK suppliers in Regulation 28 and 29 of the Health Service Products (Provisions and Disclosure of Information) Regulations 2018. This sets out the obligation to report shortages and discontinuations of medicines that have a direct impact on patients in one or more nations of the UK (England, Wales and Northern Ireland).
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Added list of contacts for questions about ensuring the flow of medical supplies into the UK.
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Added information on the new discontinuations and shortages (DaSH) portal, 2 new marketing authorisation holder (MAH) user manuals, a new MAH and admin user form, and instructional videos on the DaSH portal.
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First published.