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Parliamentary questions
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25 April 2019
E-000937/2019(ASW)
Answer given by Vice-President Katainen on behalf of the European Commission
Question reference: E-000937/2019

The Commission started in May 2017 with Brexit preparedness activities in the pharmaceutical sector(1) to ensure continued and safe access to medicinal products for patients, including in case of a disorderly withdrawal of the United Kingdom from the European Union. While no legislative preparedness proposals were necessary, the Commission worked closely together with Member States and the European Medicines Agency (EMA) to minimise any potential risk concerning supply of medicines in a no-deal scenario.

For example, with regard to the batch control testing, the Commission has informed the authorities and stakeholders that, for a specific period of time and in justified cases, competent authorities may allow justified cases controls of imported medicines to be carried out by third parties in the United Kingdom, provided that the batch is released by a qualified person established in the EU(2). This is based on the applicable legislation given the particular circumstances of Brexit.

Subject to these conditions, a temporary exemption may be given to the concerned companies by the national competent authorities or EMA.

As regards Brexit preparedness at the Union’s borders, the Commission has published a wealth of information on customs procedures, including links to relevant websites and additional information from national authorities(3). On 10 April 2019, the Commission published additional practical guidance for a no-deal scenario, including with regard to medicines and medical devices(4).

(1)Commission published early in May 2017 Notices, Questions and Answers, and Guidance documents on Brexit preparedness that were regularly updated. https://ec.europa.eu/health/sites/health/files/files/documents/ec_ema_notice_communication_brexit.pdf https://ec.europa.eu/health/sites/health/files/files/documents/qa_on_brexit.pdf
(2)https://ec.europa.eu/health/sites/health/files/files/documents/brexit_batchtesting_medicinalproducts_en.pdf
(3)https://ec.europa.eu/taxation_customs/uk_withdrawal_en
(4)https://ec.europa.eu/commission/news/no-deal-brexit-preparedness-2019-apr-10_en

Last updated: 29 April 2019Legal notice