On January 1, 2021, the United Kingdom (UK) will be considered a “third country” with important consequences regarding to Good Manufacturing Practices for drug products and APIs. There is currently no MRA (Mutual Recognition Agreement) or any other agreement to regulate the future relationship between the UK and the Erope Union.

Recently, the EMA published a complementary question and answer document that clarifies a series of questions for the transition in Nothern Ireland (part of the United Kingdom) that were raised during the Brexit negotiations. Under the Protocol on Ireland/Northern Ireland, Northern Ireland will continue to apply EU customs rules and follow its rules on product standards (known as the single market for products).

And that will make it unnecessary to control goods traveling from Northern Ireland (a non-EU country) to the Republic of Ireland (an EU country). The protocol is due to come into effect on January 1rst, 2021 – the first day of the new EU-UK relationship.

Until then, the United Kingdom remains in a transition period with the EU, which means that its trade relationship remains the same as before.

Access the Q&A document at the link: https://bit.ly/3qET9NQ