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Brexit Transition Period Is Over – What Can We Say So Far?

Michael E. MacNeir
Nora Pasinetti Sauter
Anna Maria Cesar
Brexit Transition Period Is Over – What Can We Say So Far?

The UK Entered a New Relationship with the European Union on 1 Jan 2021

The United Kingdom (UK) (England, Northern Ireland, Scotland and Whales) is no longer part of the European Union (EU) Customs Union. Simply put, it means movement of goods between the UK and the EU are now to be an import and export trade transaction. Multiple industries have been impacted, including healthcare. This article will identify a few of the key concerns from the healthcare industry, how the Brexit changes may be applicable to healthcare and considerations for how the supply chain may be organized. It is still interesting to note the regulators’ efforts to provide a few transition periods and to maintain a certain continuity to alleviate the effects of this new era. It is fair to say that it all depends on what is the product traded, where it is sourced or exported to and from.

Northern Ireland (NI) The route is a good starting point. Brexit has created an additional point of attention on Northern Ireland. Northern Ireland Protocol guarantees NI businesses will enjoy unfettered access to the UK market as well as the ability to trade within the EU’s Single Market. As a result, this allows goods to move between Northern Ireland and the Republic of Ireland (ROI) - or the rest of the EU - as they did prior to the Brexit without customs checks, tariffs, or paperwork. However, the EU has very strict rules about what can enter its market between Northern Ireland and Great Britain (England, Scotland, and Wales).

Shipments from Great Britain to Northern Ireland

Shipments from Great Britain to Northern Ireland require a customs declaration. Food and agricultural products and all goods classified as sanitary or phytosanitary are subject to health certification and specified processes. Additionally, goods considered “at risk” of onward move to the EU may be subjected to EU duties. Goods are considered not “at risk” when mainly intended for sale or final use in the UK. A few conditions are available to avoid paying tariffs (to be discussed in Part 2).

Shipments from Northern Ireland to Great Britain

Shipments from Northern Ireland to Great Britain, “qualifying goods" (mainly goods in free circulation in Northern Ireland) trade will continue as it is with no declaration, no tariffs, no new regulatory checks, no customs check with few exceptions like CITES (Convention on International Trade in Endangered Species of Wild Fauna and Flora) materials and Drug precursors. Further guidance about “qualifying goods” is to come in the course of 2021 under Gov.UK website. A strong caveat shall be put on goods starting their journey in the EU and coming to Great Britain through Northern Ireland as these must comply with Customs Export in the Home Member State and the HM Revenue & Customs must be notified with the number of the EU Export Declaration at Ports of Northern Ireland.

Shipments between Great Britain and European Union

Shipments between Great Britain and European Union require a customs declaration.

Shipments between Northern Ireland and European Union

Shipments between NI and EU will be treated as goods movement within the EU.

The requirements of Economic Operators Registration and Identification (EORI) Number and duties and taxes will be discussed in Part 2 of this Blog.


The authoring team would like to thank ISPE Investigational Products Steering Committee for reviewing the blog and providing input.

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