# Reporting requirements for medicine shortages and discontinuations

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/fa6c7b0d-73f6-4351-bf78-14caa508d7a4
Type: Guidance
Published: March 20, 2019
Updated: September 4, 2023

> This guidance document outlines the mandatory reporting requirements for Medicines Marketing Authorisation Holders (MAHs) regarding medicine shortages and discontinuations in the United Kingdom. Operating under the regulatory framework established in January 2019, which replaced previous guidelines from 2007, MAHs are legally required to notify the Department of Health and Social Care (DHSC) of any potential or actual supply disruptions. The primary mechanism for this reporting is the Discontinuations and Shortages (DaSH) portal. MAHs must appoint administrators and register users by submitting a specific set-up form to the DHSC Medicine Supply Team via email. Required actions for these entities include monitoring supply levels and promptly reporting issues through the portal to ensure the continuous flow of medical supplies. The guidance also provides updated instructions for using the DaSH portal's archive and notification features, alongside a suite of training videos covering registration, reporting, and user management. While this document does not refer to specific company inspections or historical violations, it establishes the compliance standards necessary to prevent healthcare disruptions. For sector-specific concerns, such as clinical trials or medical devices, the guidance provides direct contact information for relevant government contingency teams. Adherence to these reporting protocols is essential for maintaining the stability of the UK's medicine supply chain and ensuring patient access to necessary treatments.

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## Content

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: registration DaSH portal: password reset 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: user management DaSH portal: archiving 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

## Attachments

- [DHSC reporting requirements for medicine shortages and discontinuations](https://assets.publishing.service.gov.uk/media/608058a98fa8f51b9401005f/DHSC_Reporting_Requirements_for_Medicines_Shortages_and_Discontinuations.pdf)
- [Discontinuations and shortages (DaSH) portal MAH and administrator set-up form](https://assets.publishing.service.gov.uk/media/5f8da3b2d3bf7f49af1d4812/DaSH_MAH_and_Admin_setup_form_FINAL.ods)
- [Discontinuations and shortages (DaSH) portal: marketing authorisation holder administrator manual](https://assets.publishing.service.gov.uk/media/62d93e23d3bf7f285a88f4fb/discontinuations-and-shortages-administrator-manual.pdf)
- [Discontinuations and shortages (DaSH) portal: marketing authorisation holder user manual](https://assets.publishing.service.gov.uk/media/62d93e34e90e071e7e59c9b4/discontinuations-and-shortages-user-manual.pdf)
