101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 150 For medicines manufactured in the UK with the view to exporting these to the EU and European Free Trade Association (EFTA), th e EMA has produced guidance which can be found on their website . Although the Veterinary Medicines Directorate (VMD) does not directly issue a marketing authorisation for veterinary medicines authorised by the EU centralised procedure, the product is authorised for use in the UK and would therefore automatically become nationally authorised when the UK leaves the EU. This would prevent the need for re- authorisation at a UK level. Implications Implications for the pharmaceutical sector differ depending on whether veterinary medicines are marketed in the UK or EU/EEA market. Marketing veterinary medicines onto the UK Market After March 2019, the UK will continue to accept batch testing of veterinary medicines undertaken in the EU, EEA and the countries the EU has made appropriate arrangements, in the same manner as today. In addition, the UK will accept batch certification by Qualified Persons of veterinary medicines undertaken in the EU and EEA. Finally, EU centralised marketing authorisation holders will be required to inform the VMD if they would prefer not to have these European authorisations converted to UK authorisations. We will then confirm UK expiry of the veterinary medicine authorisation. Marketing veterinary medicines onto the EU Market After March 2019, in the unlikely event there is no agreement between the UK and the EU, the European Medicines Agency (EMA) has published guidance on its website as to the approach EU/EEA/EFTA countries would take to human and veterinary medicines certified by a UK-based Qualified Person. Please refer to th e EMA website .