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Regulation (EU) 2022/123 provides the European Medicines Agency with a framework to monitor and mitigate potential and actual shortages of centrally and nationally authorised medicinal products for human use considered as critical to address a given ‘public health emergency1 or ‘major event’2.
The European Medicines Agency (EMA) has a formal role in preparing for and managing crisis situations affecting the European Union (EU) single market for medicines and medical devices, based on legislation that took effect on 1 March 2022.
The purpose of an EUA is to allow for the use of unapproved medical countermeasures (MCMs) to diagnose, treat, or prevent serious or life-threatening disease or condition in response to a public health, military, and domestic emergency [3].
In line with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123), the MSSG will draw up a list of critical medicines for each specific public health emergency or major event, and closely monitor the supply and demand of those medicines to prevent or mitigate potential shortages.
30 wrz 2024 · You may want to stockpile medications in case of an emergency, but take care. There are safe and unsafe ways to go about it. Don't ration meds.
26 wrz 2024 · The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats ...
Emergency access to medicines (RDTL) is a financing mechanism for medicines used when a patient’s life can be prolonged, or his/her health can be significantly improved, and the available medicines reimbursed in Poland have already been used.
