The impact of Brexit on the pharmaceutical industry

Due to the substantial incertitude relating to the particulars of the withdrawal agreement, marketing authorisation holders (MAHs) of centrally authorised medicinal products must in due course consider the possible legal consequences. Therefore, MAHs of centrally authorised medicinal products should transfer the marketing authorisation to MAHs established in the Union (European Economic Area, EEA).

As a consequence of Brexit, MAHs of medicinal products authorised in a mutual recognition procedure (MRP) and decentralised procedure (DCP) where the UK is the reference member state (RMS) should designate a new RMS among the EU member states.

The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) has announced its capacity to take up the role of the RMS for medicinal products authorised in the MRP and DCP where the UK acts as the RMS. This implies that HALMED may take up the role of the RMS only for those procedures where it is involved as a concerned member state (CMS).

For nationally authorised medicinal products, MAHs located in the UK must also transfer the marketing authorisation to MAHs established in the EEA.

As a consequence of the UK’s withdrawal from the EU, the pharmaceutical industry will face many challenges that it will need to grapple with during the transition period. The real impact and scope of Brexit will only become visible during the next few years.