On 31 May 2017, the EMA published its first set of Q&A on the consequences of Brexit for MAHs. Among other issues, it confirms that the MAH must be established in the EU and therefore MAHs for centrally authorised products in the UK will need to transfer their marketing authorisation to the EU. For Orphan designation holders in the UK, the same rules apply and they must be established in the EU. The holder will therefore need to transfer its designation to a holder established in the Union. Regarding the fate of the QPPVs based in the UK, the regulations state they must reside and carry out their tasks in the EU, therefor the QPPV will be required to change their place of residence to one in the EU or a new QPPV residing in the EU will need to be appointed. With respect to the Pharmacovigilance System Master File (PSMF) located in the UK, the regulations require this to be located in the EU and the MAHs will need to change the location of the PSMF to a Member State within the EU. Mention is also made of the fate of batch release sites, the manufacturing site of the active substance and the manufacturing site of the finished product.
In short, ahead of the Brexit timeline of 30 March 2019, MAHs will need to act sufficiently in advance to ensure there is no impact on the continuity of drug supply within the EU and UK and must ensure they have implemented the changes identified in the Q&A document.
However, the ABPI has responded to the Q&A guidance document, warning that it may be premature and if companies were to follow it, there was a risk to pharma jobs and to public health. Since Brexit negotiations had yet to start, “it seems premature to advise companies to prepare only for an outcome where the UK is isolated form the European system”.
So, the question is when should the drug makers start to implement the changes? Making the required changes to remain regulatory compliant requires careful consideration given the current uncertainties and implications for tax and employment issues. Many pharmaceutical companies are now seeking advice from law firms to work out when to start the process.