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Parliamentary questions
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24 April 2019
E-001079/2019(ASW)
Answer given by Vice-President Katainen on behalf of the European Commission
Question reference: E-001079/2019

As a response to calls from the co-legislators to monitor the obligation of continuous supply laid down in EU legislation, the Commission held a meeting with experts from EU countries on 25 May 2018(1). After the meeting, the Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages(2). A document on the obligation of continuous supply to tackle shortages, including the general principles to be considered by Member States planning to introduce restrictions on the supply of medicines at risk of shortage, was also published in order to improve enforcement by national authorities(3). The European Medicines Agency and Heads of Medicines Agencies network are also working on various measures to address this problem, including improving the reporting of shortages of medicines(4).

The enforcement of EU medicines legislation is the responsibility of the Member States. An overview of Member State penalties in relation to shortages is included in the summary report of Member States’ measures to ensure continuous supply mentioned above.

EU legislation requires an authorisation to manufacture or import medicines and active ingredients. There is no requirement in the marketing authorisation regarding the number of manufacturing sites or production capacity(5).

(1)Article 81 of Directive 2001/83/EC
(2)https://ec.europa.eu/health/sites/health/files/files/committee/ev_20180525_summary_en.pdf
(3)https://ec.europa.eu/health/sites/health/files/files/committee/ev_20180525_rd01_en.pdf
(4)http://www.hma.eu/522.html
(5)Article 40 of Directive 2001/83/EC

Last updated: 24 April 2019Legal notice