Answer given by Ms Kyriakides on behalf of the European Commission

6.3.2023

The Commission is aware of the critical shortage of some medicines: antibiotics (notably amoxicillin and amoxicillin in combination with clavulanic acid) as well as some analgesics, in particular paediatric formulations. This is a concern for many EU countries and globally.

The Commission supports the European Medicines Agency (EMA), national competent authorities, the industry and other relevant stakeholders to address this issue.

The medicines impacted have been identified and are authorised at national level, and not at a central EU level. The root causes of these shortages are complex and related to many factors such as an increase in demand due to respiratory infections and production capacity issues.

Moreover, EMA’s Medicines Shortages Steering Group has asked national competent authorities to deploy all appropriate regulatory flexibilities to mitigate the shortages of medicines (e.g. English only labelling for antibiotics not intended for self-administration; acceleration of the assessment process for a new manufacturing sites).

EMA, with the national competent authorities, will continue to work with industry to identify and implement appropriate mitigation measures, notably to increase production capacity and ensure appropriate future planning to ensure continued supply of medicines to EU patients.

Pricing payment and procurement of medicines are a national competence. The Commission supports the Member States through the group of national competent authorities on pricing, reimbursement and public healthcare payers.