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How To Navigate Northern Ireland's Complex Regulatory Landscape

Many Brexit-Related Issues Are Still To Be Resolved

 
• By Ian Schofield

A TOPRA webinar gave UK-based pharma firms an idea of the complexities and uncertainties they will need to deal with when placing medicines on the market in different parts of the UK.

The EU flag and an empty space in form of the UK outlines. United Kingdom withdrawal from the European Union. Brexit concept
Brexit has placed Northern Ireland in a unique regulatory situation • Source: Shutterstock

One of the more challenging consequences of Brexit for pharmaceutical companies and distributors operating across the UK and the EU is the need to adjust to a new set of regulatory and trading arrangements for medicines destined for the Northern Ireland market.

These new arrangements – affecting areas such as product licenses, batch release and supply routes – are a result of the Northern Ireland Protocol

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