![]() Guidance is available on the measures that patients’ and healthcare professionals’ organisations can take to help prevent and manage shortages of human medicines in the EU. ![]() ![]() It complements the Guidance for patients and healthcare professionals published in 2022. The HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use developed the guidance in consultation with industry associations. Promote fair and equitable distribution to meet the needs of patients. ![]() Ensure timely communication between stakeholders in the supply chain.Optimise pharmaceutical quality systems and increase the resilience of complex, multinational supply chains.Establish robust shortage prevention and management plans.Inform national competent authorities of potential or actual shortages as early as possible, and provide detailed information to better predict impacts and implement preventive measures.Guidance is available for marketing authorisation holders, wholesalers, distributors and manufacturers to help ensure continuity in the supply of human medicines, prevent shortages and reduce the impact of any shortages that occur. Its work was temporarily suspended between March 2020 and December 2021 due to the COVID-19 pandemic. They first set up the Task Force in December 2016, building on the network’s efforts since 2012 to improve processes for handling shortages caused by good manufacturing practice (GMP) non-compliance. They also agreed to extend its mandate for further three years. Structure, work programme and terms of referenceĮMA and HMA agreed an updated structure for the Task Force in June 2022. fostering collaboration with stakeholders and enhancing communication of supply problems to EU citizens.improving sharing of information and best practices among EU regulatory authorities to better coordinate actions across the EU.encouraging best practices to prevent shortages.developing strategies to improve prevention and management of shortages caused by disruptions in the supply chain (for example developing guidance for companies on reporting of shortages).looking at ways to minimise supply disruptions and avoid shortages by facilitating approval and marketing of medicines using the existing regulatory framework (for example by work sharing and reduced timetables when possible).More information on these is available below under 'Crisis preparedness and management'. In contrast, the structures and processes that EMA set up for dealing with medicine shortages in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123) are primarily focusing on activities related to crisis situations. This aims to streamline processes, ensure synergies and avoid duplication of work within the network. the 'Joint Action on Shortages', a three-year plan starting at the end of 2022 to enhance national systems in tackling medicines shortages in a harmonised way.HMA/EMA multi-stakeholder workshop on shortages.the European Commission's Pharmaceutical Strategy for Europe.the European medicines agencies network strategy to 2025.It is designed to function as a ' supply and availability hub', tracking progress on the medicine availability and shortage-related activities that the European medicines regulatory network is undertaking under the following EU projects: It does not cover non-authorised medicines. The Task Force focuses on the availability of authorised human and veterinary medicines, irrespective of the authorisation route. The HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use is providing strategic and structural solutions to tackle disruptions in the supply of medicines and ensure their continued availability in the EU.
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