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Parliamentary questions
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19 June 2019
E-001938/2019(ASW)
Joint answer given by Mr Andriukaitis on behalf of the European Commission
Written questions: E-001938/19 , E-002103/19
Question references: E-001938/2019, E-002103/2019

The Commission is aware of the shortages of the nationally authorised medicines Sinemet and Sinemet Plus. The company announced the shortage in September 2018 and recommendations to healthcare professionals and patients on suitable alternatives were issued in individual Member States.

According to EU legislation, marketing authorisation holders must, other than in exceptional circumstances, inform Member States’ authorities at least two months before they withdraw their product from the market either permanently or temporarily, including the reasons for the withdrawal(1). As correctly stated by the Honourable Members, there is also an obligation of continuous supply to cover the needs of patients once a medicine is placed on a specific EU market(2).

The Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages, following a meeting with Member States on 25 May 2018(3). A paper on the obligation of continuous supply to tackle shortages was also agreed with Member States in this meeting(4).

In addition, Heads of Medicines Agencies/European Medicines Agency Task Force is working to develop and coordinate actions to address shortages and availability of medicines. It is currently piloting a system for internal cooperation and information sharing between national authorities. Shortages with an impact on public health are being shared through this system in order to increase awareness and facilitate Member State actions.

(1)Article 23a of Directive 2001/83/EC.
(2)Article 81 of Directive 2001/83/EC.
(3)https://ec.europa.eu/health/sites/health/files/files/committee/ev_20180525_summary_en.pdf
(4)https://ec.europa.eu/health/sites/health/files/files/committee/ev_20180525_rd01_en.pdf

Last updated: 20 June 2019Legal notice