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EMA guidance for industry to prevent and mitigate medicine shortages
  1. Stephanie Kohl
  1. Policy & Advocacy, European Association of Hospital Pharmacists, Brussels, 1200, Belgium
  1. Correspondence to Stephanie Kohl, Policy & Advocacy, European Association of Hospital Pharmacists, Brussels, 1200, Belgium; Stephanie.Kohl{at}

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In May, the European Medicines Agency (EMA) released a new guidance document outlining "Good practices for industry for the prevention of human medicinal product shortages" focused on different actors along the supply chain.

The guidance was developed by the Heads of Medicines Agencies (HMA) / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use, following an analysis of the causes of shortages and regulators' first-hand experience in coordinating the management of shortages. Industry associations were consulted during its establishment. It provides recommendations for marketing authorisation holders, wholesalers, distributors and manufacturers to minimise the occurrence of medicine shortages and their impact. Recommendations listed in the guidance include:

  • informing national competent authorities of potential or actual shortages as early as possible and providing detailed information to better predict the possible impact and implement preventive measures;

  • increasing transparency relating to shortage information through increased communication and knowledge sharing;

  • increasing the accuracy of notification detail provided, where notification has key information about the potential shortage;

  • establishing robust shortage prevention and shortage management plans;

  • optimising pharmaceutical quality systems and increasing resilience of complex, multinational supply chains throughout the lifecycle of a medicine;

  • timely communication between the various stakeholders in the medicine supply chain;

  • general principles to promote fair and equitable distribution of medicines to meet the needs of patients; and

  • taking appropriate steps to minimize the risk of parallel trade or export exacerbating shortages.

Guidance for hazardous medicinal product management

At the end of April, the European Commission released a Guidance for the safe management of hazardous medicinal products at work. It seeks to provide practical examples for reducing the workers' exposure to hazardous medicinal products across all lifecycle stages, including production, transport and storage, preparation, administration to human patients and animal patients, as well as waste management.

The new guide was developed to increase awareness …

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  • Competing interests None declared.

  • Provenance and peer review Commissioned; internally peer reviewed.