19/20 October 2021
As indicated in Brexit: U.K. will become 'Third Country' according to EU Statement, the European Medicines Agency (EMA) and the European Commission intend to provide a series of Brexit related Questions and Answers on the consequences for the pharmaceutical industry. Now, the EMA has published a first set of Q&As.
Most of the questions and answers are drug product oriented and are also discussing the location of the establishment of a company in the context of centralised procedures. But question number six gives some information about an important aspect of API distribution: the Written Confirmation.
And the Agency is clear about that: "As of the date of the withdrawal of the UK from the Union, active substances manufactured in the UK will be considered imported active substances." That means APIs imported into the European Union will need to be accompanied by a Written Confirmation from the competent authority of the exporting third country (in this case the UK), pursuant to Article 46b(2) of Directive 2001/83/EC.
Generally, after the withdrawal of the UK from the European Union (EU), "medicinal products manufactured in the UK will be considered imported medicinal products". That means: