By Regina Dawkins
Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU Commission proposal. An agreement, in principle, has been reached by the UK and EU.
The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom.
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. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result. However, the burden on the UK Pharma supply chain will be eased.
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.
Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. 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 key changes within regulations for Human medicinal products outlined in the Windsor Agreement issued by the UK Government are as follows:
- Under the agreement, the UK Government have taken on board 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 precedence of UK regulation. As a result, the MHRA will be responsible for approval of 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 license 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 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 within regulations that have not been covered or captured by the UK Government 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 relabeled 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.
The introduction of the Windsor Framework has resulted in several open questions, particularly with regard to such topics as import of medicines into NI from EU member states, the status of QP release by NI QPs and WDA/RPi requirements for NI wholesalers and distributors.
To provide answers to these questions, it is expected that there will be further information and clarification provided over the coming weeks from the regulatory authorities to support industry.
Regina Dawkins is associate director/senior consultant at PharmaLex.