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EU outlines measures to mitigate antibiotic shortage across Europe

An unseasonably early upsurge in respiratory infections has led to the increase in demand

European Medicines Agency

European officials have said that they are closely monitoring and responding to the current shortage of antibiotics across the EU through the European Medicines Agency’s (EMA’s) Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).

Established in March 2022, the MSSG coordinates urgent actions within the EU to manage medicine supply issues and issues related to the quality, safety and efficacy.

The group, along with its working party, says it has been closely monitoring the situation since November and engaging with 'key players' in the supply chain of the antibiotic amoxicillin to agree on possible mitigating measures, such as increasing manufacturing capacity.

It is also encouraging EU medicines regulatory authorities to make use of the flexibilities available, such as allowing the exceptional supply of certain medicines that may not be authorised in a particular member state or granting exemptions to certain labelling or packaging requirements.

The European Commission, Head of Medicines Agencies and EMA are also cooperating closely to investigate whether additional measures could be taken to mitigate the impact of these shortages.

The short supply of antibiotics across the EU, reportedly affecting the majority of member states, has been a growing public health concern over recent months.

The sudden increase in demand for antibiotics is due to an unseasonably early upsurge in respiratory infections in Europe this winter, along with insufficient production capacity.

The situation has also been further exacerbated by the war in Ukraine, the energy crisis and high inflation rates, several European agencies explained in a statement.

Although the situation is expected to improve in the coming months ‘based on current information from companies and stakeholders’, proposed revisions to the EU pharmaceuticals law have already been made.

Speaking at a session of the European Parliament, EU health commissioner Stella Kyriakides said the revisions could include stronger obligations for supply of medicines, earlier notifications of shortages and enhanced transparency of stocks.

Other, non-legislative measures are also being taken to keep medicine supplies for EU patients going.

The new strategy, planned for March this year, is set to “secure access to medicines for all patients in need and to avoid disruptions of medicines in the EU”, Kyriakides told the session.

Article by
Emily Kimber

24th January 2023

From: Regulatory, Healthcare



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