The Windsor Framework was proposed as a post-Brexit agreement to address the movement issue for goods between European Single Market and the Northern Ireland Protocol (United Kingdom). The announcement was made on 27 February 2023 and the agreement is covering trading flow within UK internal market and preventing Northern Ireland’s market under the European Union. Among the industries involved in the agreement are goods movements, agrifood, medicine, subsidy control and Value Added Tax (VAT) and excise.
The withdrawal of the United Kingdom of Great Britain (GB) and Northern Ireland (NI) from the European Union (EU) has raised concerns and difficulties for the industry players to adapt to the regulatory compliance of the GB and Northern Ireland. Hence, The Commission released a draft regulation to smoothen the medical supplies from the United Kingdom to Northern Ireland.
The important notes of the regulation that should be considered seriously are:
The novel medicines that are allowed to be in the NI market are those medicines authorized by the MHRA only, any EU-authorized medicines were not allowed to be in the NI market.
Compulsory to attach “UK only” wording on the medicine’s packaging to be marketed in the NI market.
No safety features authorized under Falsified Medicines Directive (FMD) are allowed to be attached to any medicine’s prescriptions in the NI market.
The expected implementation date would be 1 January 2025, however, it depends on the written agreement submitted by the UK government to the European Commission.
However, the significance of the regulation has affected some parties, Marketing Authorization Holders (MAH), for instance, who investing in Northern Ireland and the Great Britain markets. The MAH should start to consider separating the medicine packaging as the exemption expiry date is on 31 December 2024. The other implication that contributes to the consideration is medicines authorized by the Commission were banned from the NI market and must be authorized under the UK authorities only. Hence, it is compulsory to attach the wording “UK only” to the packaging.
MAH were also reminded about the exemption expiry date on December 2024. While waiting for the full implementation of the regulation, the government allows the medical products to be released by batch in Great Britain, continue QC testing without the EU retesting, proceed with the wholesale importing of authorized medicine from Great Britain and requirement exception under FMD to joint packs withdrawal to be in the UK market.
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