The pharmaceutical industry and Brexit – EU retesting within EU borders only from 1 January 2020

08/09/2019 | Dr. Franz-Josef Kappenberg
Kappenberg

Dr. Franz-Josef Kappenberg
Associate Director GxP

Batches of medicinal products to be marketed in the European Union must be tested and released by a QP in the EU27. The official post-Brexit grace period for companies that import medicinal products into the EU from or through the United Kingdom is going to be short. According to the CMDh, companies must have finished relocating their batch testing facilities to the EU27 by 1 January 2020 at the latest. Businesses that fail to comply will risk losing their marketing authorisation. International pharmaceutical companies that import medicinal products into the EU from third countries by way of the United Kingdom are just as affected as British manufacturers that have so far taken care of quality control and batch release for continental Europe within their national borders. Diapharm can help safeguard access to the European market in the short and long term.

Batch release: Brexit makes the UK a third country

Ever since EU Directive 2001/83/EC entered into force nearly two decades ago, it has been common practice for medicinal products from third countries to have to undergo batch retesting upon import into the European Union and batch release for the market by a qualified person based in Europe. Only states with a mutual recognition agreement, or MRA, are exempt from the EU retesting obligation. Those countries are Australia, Canada, Israel, Japan, New Zealand, Switzerland and the United States.

Because the United Kingdom plans to leave the European Union on 31 October 2019, making it a third country without any such MRA, the EU Commission has given competent authorities the option of creating a temporary exemption. For a limited period of time, marketing authorisation holders in the EU27 may rely on quality control testing performed in the United Kingdom if:

  • a new batch release site in the EU27 has been identified by the marketing authorisation holder by the United Kingdom’s withdrawal date and all necessary steps have been taken to prepare the transfer of the quality control testing site from the United Kingdom to the EU27, and
  • the old batch release site in the United Kingdom is supervised during the transitional period by a qualified person established in the EU27 and the site may be inspected by a competent authority of the EU27, including spot checks.

UK testing to lose recognition on 1 January 2020

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has alerted marketing authorisation holders that this grace period will end on 1 January 2020:

“It is essential that marketing authorisation holders use the remaining time to complete their preparations so that by 1 January 2020 all batch testing facilities are fully transferred to the EU27/EEA and the necessary regulatory submissions are completed.” (www.hma.eu/535.html)

Diapharm is there to help. We have been helping pharmaceutical manufacturers import and market their medicinal products in the European Union in full compliance with Directive 2001/83/EC for decades. Our Brexit team is here to support pharmaceutical companies with pragmatic solutions designed to lessen the impact of the United Kingdom’s exit from the EU. Contact us!

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