Brexit Preparation


We will be your guide through the Brexit process with support and service needed to make a successful transition to the new UK-EU regulations.

EMA will class UK as a third country from March 29th, 2019. There is a possibility you will be affected by Brexit mostly in case:

  • if you are based in the UK
  • hold an MA in the UK
  • have your EU QPPV in the UK

European Medicine Agency

Even EMA is relocating to Netherlands believing UK will become a third country since 30th March 2019. There are some challenges you might have to go through the whole process. We will provide you all services need starting from Regulatory through Pharmacovigilance and Distribution. The possible risk and discomfort will be removed from your shoulders throughout the whole process.

  • We have an EEA based system and EU QPPV based outside the UK in the EEA.
  • We can act as your MAH in EEA.
  • We can handle your RMS switching and prepare, publish and submit all the variations and transfers of MAs for your products.
  • We can handle all necessary PSMF updates & xEVMPD.
  • We can establish a legal entity in the EEA and the UK on your behalf. » About Us » Brexit Preparation