EC: General Political Agreement with UK on Northern Ireland Protocol
The Northern Ireland question was one of the trickiest open issues in the Brexit negotiations. A general political agreement has now been reached with the so-called "Windsor Framework": The European Commission and the government of the United Kingdom have put together a comprehensive package of solutions to reconcile the movement of goods to Northern Ireland while ensuring effective protective measures for the EU's internal market. The Windsor Framework is to replace the previous Northern Ireland Protocol in the future. The legally binding adoption is pending.
What would this signify for the pharmaceutical area?
- Throughout the United Kingdom (Great Britain and Northern Ireland), the same medicinal products would be available in identical packaging and with uniform labels that comply with British medicinal product regulations. Safety features, as required in the EU, would no longer be necessary for Northern Ireland. These medicinal products would therefore not be allowed to enter the EU internal market and should be labeled "UK only".
- All medicinal products, including novel ones, intended for the UK internal market would be assessed and authorised by the MHRA.
- Northern Ireland would have full access to EU and UK markets in the future.
- This access would be via a "green corridor - green lane" without customs requirements, for goods imported from Great Britain and remaining in Northern Ireland.
- A "red lane" with customs requirements, on the other hand, would be used for products coming from or destined for Ireland or the EU.
- EU-wide authorisations granted by the EU Commission under the centralised procedure would no longer apply to Northern Ireland. Instead, centrally authorised products may only be marketed in Northern Ireland if the MHRA has granted the product a UK marketing authorisation and it meets the necessary packaging requirements to protect the EU single market (UK only, no EU safety features for prescription medicines).
The Windsor Framework is expected to be approved by the EU-UK Committee before the end of March. After that, both the UK government and the EU will have to make appropriate legislative adjustments to bring it into force. In the UK, this will involve a vote in the House of Commons. In the EU, both the European Parliament and the Member States must agree.
Source:
GOV UK: Windsor Framework
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