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In a statement published on 18 June 2024, the European Medicines Agency (EMA) called on marketing authorization holders (MAHs) to adopt a Medicines Shortage Prevention Plan to reduce and prevent possible shortages and critical issues.
The purpose of such a Plan is to collect information on the product, european and international marketing, supply chain vulnerabilities, measures to prevent shortages and, where appropriate, to reduce their impact on public health, and must contain appropriate measures to address shortages and mitigate their impact on patients.
MAHs are invited to adopt a Plan for each medicinal product for human use they place on the EU market, to monitor its adequacy on an annual basis and to update it periodically or when major changes occur. To this end, the EMA has made available a template for drafting the Plan.
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