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.
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.
Updated the 'Medical Devices and Clinical Consumables (MDCC) contingency team' contact email address to email@example.com.
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.
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.
Added latest DaSH portal MAH administrator and user manuals which include instructions on new archive function, and also a new video on archiving.
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).
Added list of contacts for questions about ensuring the flow of medical supplies into the UK.
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.