UK Windsor Framework Enters Into Force
Recent UK regulatory developments of potential interest to international life sciences companies include: reforms aimed at speeding up medicines approvals and market access, global firsts with respect to certain orphan drug and cancer diagnostic approvals, and updates on unified packaging and labeling across the UK. Article authored by Dr. Chris Boyle and Dr. Kwabena Tenkorang.
New Guidance on Parallel Import Licensing Applicable to Northern Ireland Under the Windsor Framework
Brexit brought new challenges to the pharmaceutical industry, one of them being the special situation of Northern Ireland (NI), which, although part of the UK, remained subject to EU law under the NI Protocol. Pharmaceutical products placed on the NI market had to comply with EU law. For import purposes this created de facto an EU border between NI and the rest of the UK (namely England, Wales, and Scotland). The Windsor Framework provides a new set of arrangements to restore the smooth flow of trade within the UK.
The Windsor Framework’s Implications for Pharmaceutical Companies
The original agreement for the UK’s withdrawal from the EU affected the availability of medicines in Northern Ireland and created issues for importers of medicinal products. The new ‘Windsor Framework’ is better for the industry, as Marie Manley and Bronwyn Tonelli explain.
