Brexit refers to the event on 29 March2017 when the UK informed the EU of its decision to withdraw from the union. On 31 January 2020, UK officially left the EU and a transition period commenced on 1 February 2020, scheduled to end on 31 December 2020. During the transition period, the UK ceased to participate in EU institutions, including the European Medicines Agency (EMA), while still adhering to EU pharmaceutical law. As of 1 January 2021, EU pharmaceutical law no longer applies to the UK, except for Northern Ireland, which falls under the jurisdiction of the Protocol on Ireland/Northern Ireland. This Protocol is a part of the withdrawal agreement between the EU and the UK that outlines the terms of the UK's departure from the EU.

Brexit has significantly impacted thepharmaceutical industry due to the EU's harmonization of regulations and standards across its member states. Brexit has caused disruption to this harmonization, resulting in several challenges for the industry. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has now taken over the role of regulating medicines instead of the EMA. This has led to manufacturers having to apply for separate licenses to sell medicines in both the UK and EU, leading to additional costs and administrative burdens. There have also been challenges in ensuring uninterrupted supply chains for medicines due to the introduction of customs procedures and tariffs.

Following Brexit, the MHRA has releasednew regulations to ensure regulatory compliance and alignment with EUregulations. Companies are also urged to employ a variety of reliance procedures to lighten workloads and expedite the approval process, which will
lessen regulatory divergence between the EU and the UK.

Impact on EU and UK Regulatory Affairs:

The UK's exit from the EU has affected pharmaceuticalregulatory affairs in both the EU and the UK. The departure of UK from EU'sregulatory framework has resulted in separate licenses for pharmaceutical manufacturers to sell medicines in both markets, creating a duplication of regulatory processes. Additionally, the loss of the UK's contribution has
reduced the capacity and resources of the European Medicines Agency (EMA), causing challenges in its regulatory functions. The EMA has relocated to Amsterdam and expanded its operations to address this, but there could be long-term implications for the industry. The UK established its own regulatory agency, the MHRA, which took over the EMA's functions, introducing new guidelines to ensure consistency with EU regulations, but there remains some uncertainty in the industry regarding the UK's regulatory framework.

Grandfathering of centrally authoriseditems and UK Marketing Authorizations for already available products

Following Brexit, pre-existingcentrally authorized products (CAP) marketing authorizations (MA) were automatically converted to Great Britain (GB) MAs, except for cases where
marketing authorization holders opted out. One-year period have been given to submit baseline product data to have EU MAs, and variations will only be considered after that. All existing Nationally Authorised MAs are still valid in Northern Ireland, and companies must hold a valid UK marketing authorization to continue marketing their products in the UK after December 31, 2023. Companies can use the MHRA's streamlined process for "grandfathered" products that have been authorized in the EU and marketed continuously in the UK since January 1, 2021.

European Commission (EC) DecisionReliance Procedure – ECDRP

The Centralised Authorization Procedurecan now be followed for new marketing authorizations in the United Kingdom thanks to the EU Reliance Route's extension to the end of 2023. Due to potential demands for further information and resource limitations at the MHRA, the 67-day procedure to get a GB-only MA may, however, take longer. For Type II and Type IB variations, companies may choose the reliance method; however, Type IA variations must be filed to the MHRA concurrently with the EMA. Reliance processes are being encouraged by the MHRA in order to lighten the effort and expedite the approval process, which will lessen the regulatory divergence between the CAP MA and GB MA. For reliance variations, a lower fee is levied.

Regulatory Affairs in Nothern Ireland:

The Unfettered Access Procedure (UAP)enables the MHRA for Great Britain to accept Marketing Authorizations (MAs) obtained in Northern Ireland through European or national procedures. In case of no significant objections, MAAs submitted through the UAP may be granted within 67 days. The present ECDRP dependence pathway is anticipated to be
replaced by the UAP. The Northern Ireland MHRA Authorised Route (NIMAR), which was established to permit the legal delivery of prescription-only medications in conformity with EU and UK regulations, has been designated as "not marketed in Northern Ireland" on over 1,000 goods. When a clinical need cannot be satisfied by authorised products or other regulatory routes, the NIMAR is intended to make sure that people in Northern Ireland can still access prescription-only medications.

Mutual Recognition and DecentralisationProcedure for New MAs Using Reliance

The MHRA can leverage the acceptance ofMarketing Authorizations (MAs) filed via Mutual Recognition or Decentralized processes in EU member states to issue new MAs in the UK. The MRDC Reliance Procedure is what is used for this. Maintaining a UK-wide MA with Northern Ireland as a CMS, requesting separate MAs for Northern Ireland and Great
Britain, or removing Northern Ireland as a CMS and maintaining a national MA in Great Britain alone are the three options available to marketing authorization holders (MAHs) for existing MRP (Mutual Recognition Procedure) or DCP (Decentralised Procedure) products.

The Reference Member State (RMS) sendsthe MHRA the outcomes of the operation directly, which it normally accepts.

How does Brexit affect Pharmaceutical Regulatory Service Providers in the UK?

Pharmaceutical regulatory consulting organizationsin the UK have been significantly impacted by Brexit. The regulatory framework has changed since the UK left the EU, which has increased the responsibilities of the MHRA. This has required service providers to adjust to the new regulatory environment and keep up with any changes in regulations. The need for separate applications for clinical trials in the EU has created additional regulatory obstacles for such service providers, and Brexit has affected the ability of the pharmaceutical industry to trade across borders. However, there has been an upsurge in demand for regulatory services to assist pharmaceutical companies in complying with the new requirements. In order to comply with the new requirements, these companies have had to adjust to the changing regulatory environment, navigate new clinical trial and trade regulations, and offer guidance to clients.

Conclusion

Brexit has had a significant impact onthe pharmaceutical business in the EU and the UK, leading to challenges with supply chains, market access, and regulatory compliance. Since the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is now in charge of overseeing the regulation of medicines in the country, manufacturers are now
required to incur additional expenses and administrative burdens in order to sell their products in both the UK and the EU. Due to the UK's exit, the European Medicines Agency (EMA) has also faced difficulties performing its regulatory duties. To ensure regulatory compliance and consistency with EU legislation, the UK and the EU have both adopted new laws and processes.