EMA statement clarifies Brexit situation

The European Medicines Agency (EMA) has released a statement to mark the start of the transition period between the UK being a member of the European Union (EU) and becoming a third country.

The EMA says:

“The United Kingdom will formally leave the European Union on 31 January 2020 and will become a third country to the EU. On 1 February 2020 a transition period will start which is due to end on 31 December 2020.

“During the transition period, EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ will continue to be applicable to the UK, meaning that pharmaceutical companies can continue to carry out activities in the UK until the end of the year.

“Companies have until 31 December 2020 to make the necessary changes to ensure that their authorised medicines comply with EU law and can remain on the EU market. Marketing authorisation holders/applicants can still be established in the UK and Qualified Persons for Pharmacovigilance (QPPVs) and pharmacovigilance system master files (PSMFs), as well as quality control testing sites, can still be based in the UK until the end of 2020.”

Although, therefore, trading and market access activities can in many ways continue as before, companies will need to ensure they can legally operate in both the UK and EU from 1st January 2021 onwards. UK representatives will no longer be involved in the activities of the EMA.

Read the EMA statement here.

Tagged with

Published on 31. January 2020 in News, News EU, News UK, Press Release