There are requests for the EU Brexit transition period to be extended beyond 2020 into 2021, but the Government is holding firm to its intention for the Brexit to be completed by December 31, 2020, with either a trade deal or no trade deal because of the outcome. Despite the involvement of an extension from various parties, the Government of United Kingdom continues to carry its position and, while things may change, particularly in light of COVID-19, an extension seems unlikely. This means that from January 1, 2021, the United Kingdom and therefore the EU trade on the terms of the World Trade Organisation (WTO). There would be tariffs on goods passing between the EU and therefore the UK, and there would be no preferential access to markets within the absence of agreements on equivalence.
Major Impact Areas thus include, Representative entity needed in the UK separately for MRP/DCP/National and Centralised procedure, Artwork/Labelling & Packaging, QPPV, MAH for UK, GMP compliance and movement of personnel/resources in the UK 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?