The Ireland/Northern Ireland Protocol (‘the Protocol’) to the Withdrawal Agreement between the United Kingdom and the European Union has rarely been out the headlines since it came into force at the end of the transitional period on 31 December 2020. The Protocol’s impact on medicines has proved to be one of the most politically prominent issues. This article explains the way in which the Protocol applies to medicines regulation in Northern Ireland, setting it in the context of the Protocol as a whole, and looks at some of the problems that have arisen in relation to medicines and at the European Commission’s and United Kingdom government’s proposed solutions to those problems.