In particular, according to Article 51(1)(b) of Directive 2001/83/EC and Article 55(1)(b) of Directive 2001/82/EC, medicinal products imported into the EU have to undergo quality control testing (‘batch testing’) in the EU/EEA. Therefore, the process of batch testing has to be moved to the EU in order to import products and cannot be conducted in the UK any more. Subject to the condition that the UK leaves the EU on March 29, 2019, MAHs need to comply with this requirement to that date.
According to the EC, it is acknowledged that some companies may not be able to set up those processes in the EU by then. It is said that
“In these cases, Article 20(b) of Directive 2001/83/EC and 24(b) of Directive 2001/82/EC provide that competent authorities may allow importers of medicinal products coming from third countries to have in justifiable cases certain of the controls carried out by third parties.”
It is further clarified that due to this, competent authorities in the EU may allow marketing authorisation holders, for a limited period of time, as a justified case, to rely on quality control testing performed in the United Kingdom (“the exemption”), under the following conditions:
To make use of this exemption, affected MAHs have to notify the authority that granted the marketing authorisation or the EMA no later than on 29 March 2019. In the absence of such an exemption, if the testing of the batch does not take place in the EU27, as of the withdrawal date, the marketing authorisation will become non-compliant.