Technical information on what the implementation period means for the life sciences sector
In a document released by BIVDA, it aims to set out what recent developments, such as agreement on the terms of an implementation period for Brexit would mean for the life sciences sector, once finalised as part of the Withdrawal Agreement from the EU. In this important document, BIVDA highlights that market access will not change during the implementation period, and that a majority of important areas relating to market access to and from the UK will remain as they are until the end of the implementation period, 31st December 2020.
Firms can continue UK batch release testing and qualified person certification, with this being recognised by the EU and vice versa. Marketing authorisation holders and qualified persons, and qualified persons for pharmacovigilance can continue to be based in the UK and access EU markets. Manufacturing and distribution licences will continue to be recognised by the EU and vice versa, as will inspections. UK based firms can continue to apply for marketing authorisations via either the centralised or decentralised procedure. CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based manufacturers will not require an authorised representative established in the EU.
However, it should be noted that there is still no clear information for what will happen after the implementation period, BIVDA stresses that it will be updating its report as soon as new information is available.
Please head to the report for more specific information concerning market access in the UK during the implementation period, found on BIVDA’s website.