April 2023 Pharma News Update

The UK and the EU agreed on a new “Windsor Framework” for Northern Ireland (NI) that, when implemented, will change the status of medicines in the Northern Ireland.

Under the current NI Protocol, medicines in Northern Ireland are regulated by the EU, as NI is still in the EU single market to avoid a hard border on the island of Ireland.

The Windsor Framework changes this arrangement as follows:

• UK legislation, rather than EU legislation, will apply to Northern Ireland.
• The MHRA will approve medicines for the whole UK market. This means that all product approvals granted by the MHRA will automatically be valid in Northern Ireland and that pharmaceutical companies will be able to produce a single pack valid across all four constituent countries of the UK.
• The Falsified Medicines Directive provisions for medicines in NI to have safety features, such as serialization, will NOT apply anymore.
• New, innovative medicines, which in the EU would have to be assessed under the centralized procedures, will be approved under the UK regulatory system rather than managed by the European Medicines Agency.

The MHRA, HRA and Northern Ireland Department of Health put forward proposals and consulted on them from January 17 to March 14, 2023.

The organizations referenced above proposed to amend the current legislation to:

• Promote public health and ensure that protection of participants remains at the heart of legislation
• Facilitate the evaluation and development of new or better medicines to benefit patients and society, and improve public health
• Remove obstacles to innovation while maintaining robust oversight of the safety of trials
• Streamline the regulation of clinical trials and reduce unnecessary burden to those running trials by taking a risk-based approach
• Ensure that the legislation enables trial sponsors to work across countries so that the UK remains a preferred site to conduct multinational trials

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