The currently scheduled transition date in the Brexit process, 30 March 2019, is coming very close. In light of this, the European Commission (EC) published on 25 February 2019 a notice on the European rules for batch control testing of medicinal products in relation to the departure of the United Kingdom (UK) from the EU. Be aware that, if the transition date in the Brexit process will remain 30 March 2019, the notice mentioned above is fully applicable. On the other hand, any future developments in the Brexit-process may require an adjustment of the published notice.
Any medicines have to undergo quality control testing in the EU/EEA when being imported from a third country. When the UK will have become a ‘third country’, a batch control testing site within the EU remains a strict requirement in order to import medicines from the UK into the EU. There is a possibility for a temporary exemption. This exemption has to be officially requested at relevant authorities and may be granted for a limited period of time (until 31 December 2019 ultimately).
The potential risk of not complying to this requirement is very high; it may result in jeopardizing importation of involved medicines into the EU.
Marketing Authorization Holders (MAH) who are unable to transfer their Batch Control Testing site from the UK to the EU 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.
To apply for an exemption, the following conditions must be met:
As part of the exemption request, the applicant should also declare the following items:
Exemption Request: Process
The process for an exemption request is as follows:
In case of a Withdrawal Agreement (or a Mutual Recognition Agreement), the above exemption requirements are no longer applicable. If the Withdrawal Agreement, which provides a transition period, is ratified, the MAHs will be able to continue to rely on batch control testing conducted in the UK until the end of the transition period. The Withdrawal Agreement as a whole still has to be finalized and ratified.
In light of the very short remaining time period until the currently scheduled transition date in the Brexit process, it is crucial to prepare for the worst case scenario right now and to request time-limited exemptions to continue batch control testing in the UK for the very near future.