News about GMP/cGMP

08.03.2019

Brexit: News to Exemption for Batch Testing

As already reported, Marketing Authorisation Holders (MAHs) who are unable to transfer their batch testing site from the UK to the EU27 by 29 March 2019 may be permitted, for a limited period of time, to rely on quality control testing performed in the UK under certain conditions.This exempting provision has now been officially included in the EMA practical guidance as the 31st question:

Can I request a delay for transfer of batch control testing to the EU/EEA?

Furthermore, the EMA provides a 3-page template to be used for submitting such requests to the EMA.

Based on this template requests should be submitted as early as possible, but no later than on March 29, 2019 via e-mail or Eudralink (emabrexitsurveyfu@ema.europa.eu).

If the exemption is granted, the MAH must provide a copy of such exemption to the EU27/EEA competent authority that granted the manufacturing authorisation for the batch release site and to the qualified person of the batch release site. Based on the exemption and batch control testing results from the site located in the UK, the qualified person can release batches specified in the exemption for placing on the Union market.