The withdrawal of the United Kingdom from the EU on 29 March 2019 will shake up the pharmaceutical industry, too. Negotiations on a possible transition period and its terms are still ongoing. An eventual withdrawal agreement will probably be followed by a transition period lasting until the end of 2020. This would give pharmaceutical companies additional time for making changes.
Now is the last minute to act
A transition period would allow many activities to continue as before until the end of the transition period. For example, the UK would be able to conduct batch testing and release of medicinal products to the EEA markets. However, the UK would not be able to act as rapporteur or Reference Member State in marketing authorisation procedures. Without the transition period UK-based companies could not act as marketing authorisation holders in the ETA countries. In practice, if a change of the Reference Member State has not been implemented by the Brexit date, maintenance of the marketing authorisation for the product stops, because variations can no longer be submitted for the product.
Transfers of marketing authorisation holders and changes of Reference Member States are the responsibility of individual pharmaceutical companies. Many companies have not yet submitted the necessary applications, and the deadline is already around the corner. Fimea has announced that its deadline for applications for transfer of marketing authorisation holder due to Brexit is 29 November 2018.
Pharmaceutical companies must do everything in their power to minimise the impact of Brexit on the availability of medicines in Europe. We promise to help you in this. Should we start with a review of your portfolio from the Brexit angle, and then help you take the necessary action?
Hard Brexit would impact the availability of medicines
Another – very real – possibility muddying the waters is the hard Brexit where the UK leaves the EU without a formal agreement. This situation would be considerably more challenging, as immediately after Brexit, many medicine-related activities would need to be carried out from the EEA perspective by the EEA countries. The transfer of such activities requires preparation and a variation to the given product’s marketing authorisation application.
A broad range of pharmaceuticals manufacturing activities have been carried out in the UK, and many pharmaceutical companies now face changes. The European Medicines Agency has advised companies to prepare for a hard Brexit. The UK has also published guidance in the event of a hard Brexit.
Brexit is a huge challenge for both the EEA countries and the UK itself. Surely all parties want to ensure the availability of medicines and future innovations. Time is running out, many things are uncertain and there is still plenty to do.