News about GMP/cGMP

02.08.2019

Brexit: EC reminder on batch testing transfer of medicinal products to EU by 2020

From today’s perspective, the UK will be a third country as of 1 November 2019. As a result, all  batch  testing  facilities will have to be fully transferred to the EU27/EEA by  1  January  2020.  The European Commission has now published a reminder announcement regarding the requirement of batch release sites to be established in the EU. This applies also to MAHs which were granted an exemption to continue relying on quality control testing performed in the UK earlier this year (we reported).

Marketing authorization holders (MAHs) need to ensure that "all necessary  steps  have  been  taken  to  prepare  the  transfer  of  the  quality  control  testing  site  to  the EU27. Marketing authorisation holders must confirm and set out their precise timetable for transfer of the quality control testing site,” the reminder announcement says.

This should allow the process to be completed quickly and in principle by the end of 2019 at the latest.

You can follow the latest regulatory developments on Brexit visiting this EMA website.

Source:

EMA: Brexit



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