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Pharmaceutical Industry Brexit Update: Extension of the period under ‘Article 50’

The European Council agreed to a further extension of the date for the UK’s withdrawal from the EU at its meeting on 10-11 April. The extension will last as long as necessary and, in any event, no longer than 31 October 2019. For more information, see:

    •      European Council decision taken in agreement with the United Kingdom, extending the period under Article 50 TEU (11/04/2019)

    •     European Commission: Brexit preparedness activities

The UK remains a Member State for the duration of the extension, with all the rights and obligations set out in the treaties and under EU law.

EMA calls on all pharmaceutical companies to continue their preparedness for the UK’s withdrawal.

Based on the European Council decision, and until further notice, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood as referring to 31 October 2019.

If the UK fails to hold European Parliament elections, it will leave the EU on 1 June 2019 and the deadline should be understood as 31 May 2019.¹

It is clear that there remains considerable uncertainty as to the final outcome and the impact on pharmaceutical companies running clinical trials in Europe and work with contract research organizations (CROs) and contract manufacturing organizations (CMOs) based in the UK.

Companies should be active and investigate their options. Already since June 2017 the European Medicines Agency (EMA) has been very clear in stating that it expects companies to prepare and activate contingency plans in a timely manner to avoid disruptions. Read more on EMA’s Brexit-related guidance for companies
 
You should consider working with a firm that is already operating in EU27. GBA Group Pharma with it’s brands – ABF Pharmaceutical Services, LKF Central Lab, GBA Pharma Labs and Pharmacelsus - are operating in the EU for many years and can serve all your post-Brexit needs. The company is a Fully Brexit Proof Organisation as all of our facilities and Qualified Persons (QPs) are located in mainland Europe - in Austria and Germany.
 
GBA Group Pharma has made significant investments to accommodate the increase in import and release activities and increased our capacities in the relevant areas. Working with GBA Group Pharma will provide you with the following solutions:

    •      Long-Term Expertise
    •      a Brexit Solution
    •      Continuity & Cost Effective Solutions to your Clinical Trial Requirements

Contact our experts to discuss your specific needs.

Phone +43 1 890 12 00 - 0
www.abf-pharma.com/contact/

 


¹ https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/brexit-related-guidance-companies

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