Preparing for a no-deal Brexit

Do you have any advice for pharma companies to ensure they are prepared?

“The pharmaceutical industry has primary responsibility for the continuity of supply of medicines and ensuring they are compliant with regulatory requirements. Thus, EMA and EU authorities have been reminding industry of the need to plan and take any necessary regulatory steps to ensure their medicines remain on the EU market post Brexit; thus minimising disruption to medicines supply and avoiding shortages. Since May 2017, we have been providing guidance to help pharmaceutical companies prepare for Brexit. According to EU legislation, the marketing authorisation holders of all EU medicines must be located within the EU/EEA. Marketing authorisation holders currently based in the UK should be transferred to the EU/EEA territory for their medicines to remain authorised in the EU. In addition, for medicines authorised via decentralised or mutual recognition procedures, the Reference Member State must be an EU/EEA Member State. Marketing authorisation holders carrying out certain operations in the UK need to implement several regulatory steps in order to guarantee continuous supply of their medicines in the EU/EEA territory. This includes changing the location of their qualified person for pharmacovigilance (QPPV), relocating their pharmacovigilance system master file (PSMF) or relocating some manufacturing sites.”

Will the EMA’s move to Amsterdam impact pharma companies in any way?

“All EMA’s core activities related to the evaluation and supervision of medicines will continue uninterrupted, and to the same quality and timelines during the Agency’s relocation to Amsterdam and throughout 2019. Except for some delays in processing of EMA certificates, there should be no impact on other EMA procedures (eg, scientific advice, orphan designation, paediatric investigation plans (PIPs), applications for marketing authorisation, and post-authorisation activities). Companies are advised to submit applications and requests as normal. Between 11 February and 15 March 2019, while EMA moves to its new premises, no pre-submission meetings for initial marketing authorisation applications will take place. Once we are settled in the Netherlands, companies will travel to Amsterdam rather than Canary Wharf for oral explanations and other face-to-face meetings with EMA.”

Are there still concerns around centrally authorised medicinal products?

“Concerning centrally authorised medicinal products (CAPs), we have sent a survey to those companies that hold their marketing authorisations and are located, or carrying out certain operations, in the UK. This survey was intended to identify those medicines that will require regulatory changes and industry’s plans for implementing these changes. The outcome of EMA’s survey to industry on centrally authorised medicinal products, which identifi ed gaps in the industry’s preparedness, was published in July 2018. It showed that marketing authorisation holders for more than half (58 percent) of the 694 CAPs with an important step in their regulatory processes in the UK, were on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the European Union. However, for 108 (88 human products and 20 veterinary products), or 16 percent, of these medicines with manufacturing sites located in the UK only, there were serious concerns that the necessary actions will not be carried out in time. For 10 percent of the products included in the survey, EMA received no feedback from companies. Since July, EMA has been contacting these individual companies and reminding them of their obligation for continuity of supply. As a result, the majority of marketing authorisation holders concerned have taken steps to either transfer their marketing authorisation to an EU/EEA country; change their QPPV; relocate their PSMF; adapt their logistics, supply chains and contracts; or relocate some manufacturing sites. For products where there are still outstanding issues, the Agency has been working directly with the marketing authorisation holders to address them. In addition, EMA has been analysing how best to minimise potential supply disruptions and any resulting impact on public and animal health. It is discussing relevant mitigation measures with its scientifi c committees, including recommendations on possible therapeutic alternatives to which patients could be switched if necessary.”