UK – Exporting active substance manufactured in the UK in a no deal scenario

Information on the ‘Written Confirmation’ process, for active substances manufactured in the United Kingdom (UK), that will be adopted in a no deal scenario.

Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario.

This guidance will apply from exit day in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.

In the event of a no deal scenario, we will continue to accept importation of active substances into the UK without a Written Confirmation from the same list of countries as currently (European Economic Area (EEA) countries, USA, Japan, Brazil, Australia, Israel and Switzerland).

Further guidance is available on importation of active substances from countries on a list