The European Medicines Agency has approved approximately 50 out of 60 applications from drug companies applying for the temporary batch testing exemption. MA holders granted the exemption are provided with additional time to move their batch testing sites for centrally authorised products (CAPs) from the UK to the EU. Instead of the Brexit deadline (currently set for 31 October 2019 and subject to change if the UK and EU ratify a withdrawal agreement before then), quality control testing may continue to be performed in the UK until 31 December 2019. For more details, please see here and here.
Under a no-deal Brexit, UK-manufacturered products would have to pass through quality control testing within the EU and be released by a Qualified Person established in the EU before they can be imported into the EU. If companies wanted to continue placing products in the EU market, UK batch testing sites would need to transfer to within the EU27 by the Brexit deadline. Please see here for our previous blog post on this issue.
The European Commission recognised that there may be “objective reasons beyond control of marketing authorisation holders that may prevent timely transfer of such testing activities”. As such, the Commission introduced the exemption in February this year, making clear that it would only be granted in “justified” circumstances and subject to strict conditions.
According to the EMA’s Marie-Helene Pinheiro, applications were unsuccessful because they fell outside the exemption’s scope (i.e. requests were made for exemption from non-UK based quality control testing).
Companies that have yet to submit an application are encouraged to apply for the exemption as soon as possible. The original deadline of 29 March has now been extended to the new withdrawal date.