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EU pharmaceuticals law changes to avoid medicine shortages - 0 views

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    Proposed changes to a European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages, EU Health Commissioner Stella Kyriakides said last week (January 17). Kyriakides told a session of the European Parliament that shortages of antibiotics are a growing problem for many European countries. She said the European Commission's proposal to revise the pharmaceuticals legislation is planned for March. "Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said. Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency says. The unseasonably early upsurge in respiratory infections in Europe this winter and insufficient production capacity are the root causes of the shortages, Kyriakides said. Numerous EU lawmakers speaking at the session said the shortages needed to be tackled urgently. But experts say shortages of essential generic medicines like antibiotics are likely to be recurrent in Europe due to problems in the sector such as the gradual migration of generic manufacturing to Asia.
pharmacybiz

EU Unveils Ambitious Plan to Tackle Supply Crisis - 0 views

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    The European Commission launched an initiative to deal with the ongoing supply crisis on Tuesday (24 October). The following announcement comes after the shortage of key antibiotics last winter identified by the European Health Emergency Preparedness and Response Authority (HERA) and the European Medicines Agency (EMA). The "European Voluntary Solidarity Mechanism" is a proposed short-term measure that involves a Member State's need for a given medicine to other Member States to redistribute medicines from their available stock. Additionally, the Commission intends to cooperate with member states to improve components of pharmaceutical reform with an aim to strengthen supply security. They are setting up a few actions apart from the launch, a list of critical medicines to analyse the supply chain by early 2024; regulatory flexibilities; strengthening security of supply; and availability of antibiotics and treatments for respiratory viruses by next winter.
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