EU Adopts New Rules On UK-Wide Approvals For Novel Drugs
Having been passed by the European Parliament and now the Council of the EU, new legislation will clear up some of the issues raised by Brexit relating to trade in medicines between Great Britain and Northern Ireland.
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One of the many consequences of Brexit is that medicines for marketing across the UK will have to carry the words “UK Only,” which will involve companies having to notify the regulator of changes to their product artwork.
As part of post-Brexit arrangements to make sure new drugs are made available to people in all four countries of the UK, an interim mechanism has been set up for when a product is approved in the UK before the EU.
Giving the UK regulator the power to issue UK-wide marketing authorizations for products that fall within the scope of the EU centralized procedure will reduce the regulatory burden on companies marketing medicines in Northern Ireland.