Where the United Kingdom Government to vary its position and comply with an extension of up to two (2) years (as is permitted within the WA), the EU has already indicated its willingness to extend, subject to appropriate conditions being met. These conditions (EU Brexit longer extension), which include financial liabilities, would wish to be carefully negotiated because the UK would be reluctant to extend its contributions to help within the EU recovery from COVID-19. But an extended extension is what the best and most realistic route to secure a comprehensive trade deal.
Major impact areas thus include, Representative entity needed in the EEA for MRP/DCP/National and Centralised procedure, Artwork/Labelling & Packaging, QPPV, MAH for EU, GMP compliance and movement of personnel/resources to EU states for Market access, Clinical trials compliance etc.
To read more about each area affected, what you need to do is to stay ahead of the curve. How Freyr can help ease your transition into these new guidelines?