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:
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!