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Parliamentary questions
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1 October 2019
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-002503/2019

According to EU legislation, marketing authorisation holders must inform Member State authorities at least two months before temporary or permanent market withdrawals(1). They are also obliged to ensure continuous supply for medicines placed on a specific EU market(2).

Following a meeting in 2018, the Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages(3).

The Commission addresses issues of access and availability through the Pharmaceutical Committee, the Expert Group on Safe and Timely Access to Medicines for Patients(4) and by supporting relevant projects and initiatives via the EU Health Programme(5).

The Commission also analyses the effectiveness, accessibility and resilience of health systems as part of the European Semester(6).

In addition, Heads of Medicines Agencies/European Medicines Agency Task Force is working to address shortages and availability of medicines. Shortages with an impact on public health are being shared between Member States in order to increase awareness and facilitate action.

The Commission is currently reflecting on possible additional ways to address shortages of medicines.

(1)Article 23a of Directive 2001/83/EC
(2)Article 81 of Directive 2001/83/EC
(5)For instance https://webgate.ec.europa.eu/chafea_pdb/health/projects/664317/summary

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