# Medicine supply management

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/f1c131c4-6b61-4350-a628-912488071a7e
Type: Detailed Guide
Published: April 7, 2026

> The Department of Health and Social Care (DHSC) and NHS England oversee the management of medicine supply chains across the United Kingdom. This guidance outlines the framework for mitigating disruptions caused by issues such as raw material shortages, packaging delays, and regulatory compliance testing. Under current regulations, manufacturers have a legal obligation to report any potential medicine shortages or discontinuations through the Discontinuations and Shortages (DaSH) portal. While DHSC holds strategic responsibility for England, it coordinates closely with the Medicines and Healthcare products Regulatory Agency (MHRA) and devolved governments to ensure equitable access to medications nationwide. When a supply issue is identified, DHSC and NHS England assess its impact alongside industry partners. Management strategies include issuing Medicine Supply Notifications (MSNs) to healthcare professionals and utilizing the NHS medicines supply tool. In significant cases, Serious Shortage Protocols (SSPs) allow pharmacists to provide alternative medications without a new prescription. Additionally, the MHRA may issue National Patient Safety Alerts for complex shortages. The guidance emphasizes that companies must adhere to export and hoarding restrictions to maintain domestic supply. While specific inspection dates and company-specific violations are not detailed in this general policy document, the framework establishes a mandatory reporting system to prevent patient harm. Manufacturers are encouraged to consult MHRA guidelines on regulatory processes designed to ease supply pressures.

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## Content

Introduction The Department of Health and Social Care ( DHSC ), in collaboration with NHS England and supply chain partners, is committed to managing and mitigating medicine supply issues across the UK. Medicines licensed for use in the UK are sourced from a complex, highly regulated and global supply chain. Disruption can occur at any point in that end-to-end supply chain, from problems with raw materials and packaging production, to regulatory compliance testing, certification and ‘last mile’ delivery to patients. For more detailed information on the causes of medicine supply disruption and how resilience is being strengthened, please see the joint DHSC and NHS England 2025 policy paper Managing a robust and resilient supply of medicines . National management of medicines supply DHSC has overall policy, strategic and operational responsibility for helping to ensure the continuity of the supply of medicines for all NHS services in England. NHS England’s Medicines Procurement and Supply Chain ( MPSC ) team has specific responsibilities for: managing the continuity of supply for secondary care medicines some homecare services procured through MPSC frameworks The role of DHSC and NHS England is to work closely with regulatory, pharmaceutical industry and clinical partners across the medicines supply chain, to help reduce the frequency of shortages and minimise patient impact when they occur. While the rest of the UK has devolved powers to control the supply of medicines (including procurement, storage, allocation and distribution), DHSC regularly engages with the devolved governments to discuss potential supply issues. Where agreed, we take the necessary actions to mitigate supply disruptions for the whole UK in collaboration with all UK countries to help ensure all patients have equitable access to medicines. Notification of shortages Manufacturers have a legal obligation to notify DHSC of any medicine shortages and discontinuations that meet the reporting criteria - see guidance on Reporting requirements for medicine shortages and discontinuations , which includes information for manufacturers ahead of reporting an issue. Suppliers need to submit notifications about potential supply issues on the discontinuations and shortages (DaSH) portal (sign in required). Assessment of shortage notification Upon receiving notification of a medicine shortage, DHSC and NHS England work closely with manufacturers, wholesalers and other partners to assess the impact and decide on an appropriate course of action to manage a supply issue. DHSC and NHS England have published a comprehensive guide to the systems in place nationally for responding to a medicine shortage - see the guide to the systems and processes for managing medicines supply issues in England . Communications in response to shortages In the first instance, guidance for the management of medicines shortages is issued only to healthcare professionals through: medicine supply notifications (MSNs) the NHS medicines supply tool, a searchable, web-based tool hosted by the NHS Specialist Pharmacy Service ( SPS ) Where appropriate, serious shortage protocols ( SSPs ) are published by NHS Business Services Authority (NHSBSA). SSPs support the management of shortages where an alternative medicine or quantity may be dispensed by pharmacies. In more complex shortages, where relevant criteria are met, accredited organisations can issue a national patient safety alert (NatPSA) on the Medicines and Healthcare products Regulatory Agency ( MHRA ) central alerting system. Further information and guidance See MHRA guidance on the steps manufacturers and suppliers can take to ease supply shortages: Medicines shortages: regulatory processes to manage supply disruptions . NHS SPS offers guidance, resources and professional medicines advice including: understanding unlicensed medicines leaflets and posters for patients and healthcare professionals on the impact and management of medicines supply issues See also DHSC ’s export and hoarding restriction list which outlines the medicines that you cannot export from the UK or hoard .
