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Preserving our Defences – Prudent and Appropriate Use of Antimicrobials

Legal and Regulatory Interventions on Antimicrobial Resistance in the Recent Commission Proposal to Review the EU Pharmaceutical Legislation

Aleksandra Opalska, Florian Schmidt

DOI https://doi.org/10.21552/ehpl/2023/2/5



Antimicrobial resistance (AMR) is an increasing threat to public health. A key factor that accelerates AMR is the misuse and overuse of antimicrobials. Access to antibiotics without prescription, self-medication, as well as lack of rapid and sufficient diagnostic tests are among the most important drivers of AMR. This article will focus on legal and regulatory interventions to avoid the misuse and overuse of antimicrobials taking into account the recent Commission proposal to review the EU pharmaceutical legislation (Directive 2001/83 and Regulation (EC) 726/2004), which was published on 26 April 2023.

Aleksandra Opalska, Directorate-General for Health and Food Safety, European Commission, Brussels, Belgium; Division Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, the Netherlands. For Correspondence: <Aleksandra.OPALSKA@ec.europa.eu>. Florian Schmidt, Directorate-General for Health and Food Safety, European Commission, Brussels, Belgium. For Correspondence: <Florian.schmidt@ec.europa.eu>.

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