BREXIT
The United Kingdom has formally left the European Union on 31 January 2020 and has become a third country to the EU. On 1 February 2020 a transition period has started 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), as well as manufacturing/quality control testing/batch release sites, can still be based in the UK until the end of 2020.
The withdrawal agreement foresees that following its departure from the EU on 31 January 2020, the UK will no longer participate in EU institutions and their decision-making. For the CMDv this means that as of 1 February 2020, no one who represents the UK, or is appointed or nominated by the UK can systemically participate in the CMDv meetings. During the transition period, the UK will not be able to act as RMS in MRP/DCP, but the UK can participate in MRP/DCP as CMS.
The European Commission announced on the 19th December 2022, an extension until 31st December 2025, of the application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through parts of the UK. This allows companies and operators in Ireland, Northern Ireland, Cyprus and Malta to comply with EU law and prevent shortages of veterinary medicines.
Practical guidance for procedures related to Brexit for veterinary medicinal products approved via MR/DC procedures (January 2022)
Questions & answers: EU actions to prevent medicine shortages due to Brexit (link to EMA website)