Reporting requirements for medicine shortages and discontinuations

AI Summary

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.