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Parliamentary questions
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17 January 2019
E-005528/2018(ASW)
Joint answer given by Mr Andriukaitis on behalf of the European Commission
Written questions: E-005528/18 , E-005596/18
Question references: E-005528/2018, E-005596/2018

The Commission is aware of the potential risk to public health caused by Brexit, in particular as regards the supply of medicinal products, included vaccines, to patients.

The Commission services together with the European Medicines Agency (EMA) and the national competent authorities have taken preparedness measures since the early stages of the Brexit process to mitigate risks of supply shortages. Dedicated questions and answers have been published and regularly updated on the websites of the Commission(1), EMA(2) and the Heads of Medicines Agencies(3).

EMA conducted an industry survey to identify possible products that could be at risk of supply shortage(4). National competent authorities are currently carrying out similar preparedness activities for nationally authorised products.

Vaccines are part of this assessment. Regulators and industry representatives are discussing the matter regularly in technical meetings.

The Commission has consistently called on all stakeholders in all sectors to take all the necessary measures so that they are ready for all possible scenarios(5),(6). In this context, companies are expected to engage with the regulatory authorities as necessary and bring to their attention any specific issues related to vaccines, including seasonal and pandemic influenza vaccines.

Regarding the future relationship between the EU and the United Kingdom (UK), the Commission refers the Honourable Member to the ‘political declaration setting out the framework for the future relationship between the EU and the UK’(7).

(1)https://ec.europa.eu/health/sites/health/files/files/documents/qa_on_brexit.pdf
(2)https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit
(3)http://www.hma.eu/535.html
(4)https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/brexit-related-guidance-companies#survey
(5)https://ec.europa.eu/info/sites/info/files/communication-preparing-withdrawal-brexit-preparedness.pdf
(6)https://ec.europa.eu/info/sites/info/files/brexit_files/info_site/communication-preparing-withdrawal-brexit-preparedness-13-11-2018.pdf
(7)https://ec.europa.eu/commission/brexit-negotiations_en

Last updated: 18 January 2019Legal notice