News Category: Regulatory news
The European Commission has published (25 February 2019) a communication entitled Withdrawal of the UK and EU rules for batch testing of medicinal products.
In relation to quality control (QC) testing, the Commission has noted that there may be objective reasons beyond the control of marketing authorisation holders (MAHs) that may prevent timely transfer of QC testing to an EU/EEA site by the withdrawal date. The Commission letter outlines circumstances under which competent authorities may allow, by way of exemption, on-going release of medicines onto the EU market based on QC testing performed in the UK. Please note that these provisions are subject to conditions and will apply for a limited time period up until end December 2019 at the latest.
The Commission also outlines in this statement that a batch release site in the EU 27 will need to be identified by the MAH before 29 March 2019 so that on-going EU compliance can be assured post withdrawal.
Applications for an exemption must be submitted as soon as possible and in no case later than 29 March 2019. The HPRA is inviting companies who may wish to submit such an application to contact us as soon as possible for details of the procedure involved.
Companies are reminded that the MAH must be EU based as of 30 March 2019 and any outstanding MAH transfers must be urgently submitted to allow processing by the withdrawal date.
The HPRA remains available to discuss particular challenges presenting to stakeholders and in particular would welcome the opportunity to clarify any aspects of this exemption process with your Brexit representatives in the coming days. Please contact us using the relevant e-mail address below: