The following is a brief summary of changes within the Northern Ireland regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023.
The agreement, in principle, has been reached by the UK and EU regarding the Windsor Framework.
The new way forward on the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively.
Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for Northern Ireland. This may impact the supply chains of companies where provisions and changes were made to supply chains such as introduction of GB specific pack. However, it will ease the burden on the UK Pharma supply chain.
Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products within the Northern Ireland market.
In addition, the agreement safeguards smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms. The pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.
The Winsor Agreement issued by the UK Government outlines the following:
• Under the agreement, the UK Government have listened to the needs of industry and the healthcare sector by securing an unprecedented settlement that provides a comprehensive carve-out from EU rules: fully safeguarding the supply of medicines from Great Britain into Northern Ireland, and once again asserting the primacy of UK regulation. As a result, it will be for the MHRA to approve all drugs for the whole UK market. This will enable all types of medicines to be supplied in single packs, within UK supply chains, with a single licence for the whole UK. This will provide a long-term, durable basis for medicines supply into Northern Ireland.
• Specifically, the whole of the Falsified Medicines Directive has been disapplied for medicines supplied to Northern Ireland, ending the unnecessary situation in which – even with grace periods – wholesalers and pharmacies in Northern Ireland were expected to keep barcode scanners to check individual labels.
• For the provision of innovative drugs to patients, Northern Ireland will be reintegrated back into a UK-only regulatory environment, with the European Medicines Agency removed from any role in regulation.
• The original Protocol also required a range of onerous authorisations and movement conditions for veterinary medicines entering Northern Ireland. These failed to take account of the overwhelming reliance of Northern Ireland on veterinary medicines from Great Britain, putting more than half of product lines at risk. As part of the agreement, a grace period arrangement has been put in place until the end of 2025 which enables veterinary medicines authorised or approved in the UK, or which are moved via Great Britain, to continue to be placed on the market in Northern Ireland. This safeguards those supplies, while providing time to establish a long-term solution which maintains the uninterrupted flow of veterinary medicines into Northern Ireland from Great Britain as is the case now.
• In so doing the Government is clear that the only practical solution will be a solution, as with human medicines, to guarantee the existing and long-established flows of trade between Great Britain and Northern Ireland on which so many people and businesses rely.
The EU proposal on specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland issued on 27th February introduces some additional points that aren’t covered or captured by the UK published Windsor Agreement:
• EU safety features that must be displayed on packs of medicines subject to prescription in the Union, should not appear on packs of medicines made available to patients in Northern Ireland. These solutions are accompanied by safeguards to ensure that all medicines placed on the market in Northern Ireland will not be made available in any Member State.
• Medicines for NI must include labelling of packs with a specific label: “UK only”.
• MHRA must continuously monitor the placing of medicinal products onto the market in Northern Ireland and the effective enforcement of the specific rules.
• UK only medicinal products shall not be moved from Northern Ireland to a Member State or be placed on the market in a Member State.
• Medicinal products that have been lawfully placed on the market in Northern Ireland before the date of this new Regulation, and that are not repackaged or relabelled after that date, may be further made available on the market in Northern Ireland until their expiry date without being required to comply with the specific rules laid down above.
There are still several open questions raised by the introduction of the Windsor Framework, particularly with regard to such topics as import of medicines into NI from EU member states, status of QP release by NI QPs and WDA/RPi requirements for NI wholesalers and distributors. To answer these questions, it is expected that there will be further information and clarification provided over the coming weeks from the Regulatory Authorities.