Brexit – Impact of COVID-19

Brexit – Impact of COVID-19

On 23 June 2016, the United Kingdom narrowly voted to leave the European Union, a decision which has impacted the lives of millions of people. Once the results of the historic vote were revealed, who would have predicted that the process to leave the European Union...
Brexit – MAH & QPPV Location

Brexit – MAH & QPPV Location

Marketing Authorisation Holder (MAH) and Qualified Person for Pharmacovigilance (QPPV) location Establishment of the MAH The MAH for a UK MA must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA. An exception to this requirement applies in...
Brexit – Variations

Brexit – Variations

Now that the Brexit transition has taken place you may be wondering what your options are for submitting new variations or how your pending variations will be processed. Here is a summary of how Marketing Authorisations (MAs) will be handled according to the process...