EMA on potential Impact of Coronavirus

Recommendation

7/8 May 2024

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The European Medicines Agency (EMA) and its partners in the European medicines regulatory network are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the European Union (EU). A first meeting of the EU Executive Steering Group on shortages of medicines caused by major events was organised to "discuss measures aimed at addressing the impact of the outbreak of COVID-19 on the supply of medicines in the EU". Supply issues can be expected if lockdowns continue and/or other supply disruptions occur e.g. caused by logistical problems or export restrictions.

Task of the group

• Identify and coordinate EU-wide actions to protect patients when medicines in the EU are at risk of supply shortage.
• Ensure that patients and healthcare professionals across the EU are kept informed in a consistent and transparent manner about the risks and the remedial actions taken.
• Industry associations at national and EU-level will be asked to provide further information on the resilience of companies' supply chains to regulators, which will be monitored through the steering group.

Actions already taken

• Measures to monitor the potential impact of the COVID-19 outbreak on medicines; information sharing via the Single Point of Contact network on shortages.
• EU pharmaceutical industry associations were requested to raise awareness among their members of the potential impact of quarantine measures in China and elsewhere on the supply of medicines in the European Economic Area (EEA). Any possible shortages should be reported to the EU authorities.
• Associations should assess the preparedness of their members to prevent possible shortages that may result from the outbreak.
• National medicines regulators are requesting information from marketing authorisation holders and/or manufacturers in their Member States.
• Ongoing review of manufacturing information for centrally authorised human and veterinary medicines to identify those most at risk of shortages and disruptions and prioritise them for discussions about remedial actions.