The Windsor Framework will contain new arrangements for a wide range of areas, including amongst others, medicines, agri-food, customs, VAT and excise. A fundamental principle underpinning the new arrangements is a clear distinction between goods destined for the UK internal market and goods at risk of entering the EU’s Single Market.
While we await further detail on the impact this will have on medicines, the new arrangements suggest a fundamental change to the existing system under the NIP. That is, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), will be responsible for assessing all medicinal products, including new and innovative products, destined for the UK internal market. This will result in a single UK-wide marketing authorisation (MA) and a single “UK only” labelled pack that complies with UK medicine rules and can move freely between GB and NI. Importantly, it appears that EU-wide MAs granted by the Commission under the centralised procedure will no longer apply to NI. Instead, centrally-approved products may be placed on the market in NI only if the MHRA has granted the product a UK MA and it complies with the necessary packaging requirements to safeguard the EU’s Single Market. That is, the pack must be labelled “UK only” and for prescription-only medicines, cannot display EU safety features (unique identifier/barcode).
Although a single medicines regulatory framework for the entire UK will be welcomed by many, companies may yet again have to adjust their supply chains, in particular for centrally approved products that currently have a common EU pack for NI and other Member States.