Study On Impact of Brexit On Drug Product Registration

Abstract

Brexit is the term coined in March 2017, when the United Kingdom (UK) notified the European Union (EU) of its intention to leave the alliance; and in January 2020 the UK formally exited the EU. This big decision of the UK has not only affected the political scenario but also affected the on-going functionality of various fields, and the pharma field considered as one of the most regulated industries has been affected a lot. The transition period began from February to December 2020, whereby many regulatory approval processes were at different stages were affected a lot like a centralized and decentralized pathway. The UK withdrew from EU institutions, notably the European Medicines Agency (EMA) during this time; while EU pharmaceutical law remained in force in the UK, which had generated a lot of turbulence. Except for Northern Ireland, which is governed by the Protocol on Ireland / Northern Ireland; EU pharmaceutical law has been outlawed in the UK since January 2021. The Protocol is a part of the EU-UK separation agreement, which outlined the conditions of the UK& is exit from the EU. The aim of the present investigation studies the impact of Brexit on drug product registration in the UK as well as, other alliance countries as an EU. Two different scenarios demonstrated in the present study to as dossier submission process for UK-NI vs UK-GB. The present regulatory research will clarify queries regarding regulatory compliance submission formats and processes for drug product approval of the desired country for marketing. On January 31, 2020, the United Kingdom formally exited the European Union. The transition period began on February 1, 2020, and ended on December 31, 2020. The UK withdrew from EU institutions, notably the European Medicines Agency (EMA), during this time, while EU pharmaceutical law remained in force in the UK. Except for Northern Ireland, which is governed by the Protocol on Ireland/Northern Ireland, EU pharmaceutical law has been outlawed in the UK since January 1, 2021. The Protocol is a part of the EU-UK separation agreement, which outlined the conditions of the UK & exit from the EU. The UK-EU is in the II scenario, as the first scenario requires applicants to send their dossier to the EU Competent Authority rather than the UK Competent Authority because Northern Ireland is part of the EU Union.