Last updated: 28 October 2024
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On 27 February 2023, the European Commission and the Government of the United Kingdom announced a political agreement in principal on a new way forward –The Windsor Framework.
This new way forward is a tangible manifestation of the shared desire for a positive bilateral relationship between the United Kingdom and the European Union, based on their continued commitment to the two Agreements that govern their relationship – the Withdrawal Agreement and the Trade and Cooperation Agreement, which is the cornerstone of their bilateral relations.
You can read more about the new deal here.
On 24 March 2023, the EU-UK Joint Committee adopted a decision laying down the arrangements relating to The Windsor Framework. A series of recommendations, Joint Declarations and Unilateral Declarations have also been published, clarifying how different aspects of the Windsor Framework will work in practice.
On 9 June 2023, the MHRA published further information and publications (updated further on 28 July 2023 with new guidance links) on the Windsor framework as well as a medicines announcement.
Key points of the Windsor framework applicable to medicines
The key points of the framework applicable to medicines are:
- Points no 35-38 on pages 14 and 15 of the The Windsor Framework
- Point no 47 on page 18 (veterinary medicines)
Point no 36 is detailed below in in its entirety:
Under the agreement, we have listened to the needs of industry and the healthcare sector and secured 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 supplies 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.
- And 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 having any role.
- This responds to the overwhelming calls from industry for stability and certainty, and can give reassurance to patients and clinicians in Northern Ireland well into the future.
This explainer document could help to clarify the points above.
Information on the EU commission website
There is more detailed information available on the European Commission website including this section entitled Questions and Answers on Commission Proposal to ensure continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta. A pdf of the Q&A can be downloaded here.
All the relevant points from the Q&A are detailed below:
The Commission has proposed to change EU rules 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.
On generic medicines
- Generic medicines will be authorised under national UK procedures, in compliance with EU substantive rules on medicinal products
- Pharmaceutical companies will have the option of choosing either the UK authorisation process or an EU Member State procedure.
- If companies opt for the UK national procedure, the UK regulator will not have to agree the terms of the authorisation with Member State authorities and will be solely in charge. In such a scenario, authorisation by the UK regulator could allow companies located in Great Britain to use a single pack and single leaflet when supplying markets in Great Britain and Northern Ireland. There would be no need for separate packaging.
- All regulatory functions will remain wherever they are now in the UK. This means that there is no need to relocate any regulatory functions or testing facilities from Great Britain to Northern Ireland.
- Batch testing carried out in the EU does not need to be repeated when medicines are brought into Northern Ireland through Great Britain.
On life-saving Innovative Medicines (e.g. new cancer medicines)
- People in Northern Ireland will continue to have access to novel, innovative life-saving medicines at the same time as people in other parts of the UK
- A ‘bridging solution’ will allow any new medicine authorised in the UK to be supplied to Northern Ireland, until the relevant authorisation is also given in the EU.
- Those temporary authorisations should be time limited and cease once a decision on the medicinal product is taken at EU level.
- This solution covers any medicine that may need to undergo assessment by the European Medicines Agency and be authorised by the European Commission.
- This ‘bridging solution’ is in addition to the existing compassionate and emergency use early access mechanisms under EU law.
On procedures for the supply of medicines from Great Britain to Northern Ireland (applicable to all medicines)
- No manufacturing authorisation or import license will be required for bringing medicines into Northern Ireland from the rest of the United Kingdom
- In addition, EU medicine unique identifiers – that ensure prescription medicines are genuine – will not need to be removed from prescription medicines that transit through Great Britain to Northern Ireland for another three years. This is a derogation from the rule that unique identifiers must be removed when prescription medicines leave the EU and are exported to a third country. This will avoid the need for affixing a new identifier when those medicines enter Northern Ireland from the rest of the United Kingdom and will allow more time for industry to adapt.
Addressing the situation in Cyprus, Ireland and Malta
- Historically, many medicines in Cyprus, Ireland and Malta have been supplied through or from Great Britain
- The UK’s withdrawal from the EU has made it challenging for operators in these Member States to comply fully with EU law
- In order to address this situation, prevent shortages of medicine, and ensure a high level of public health protection, Cyprus, Ireland and Malta will benefit from certain derogations for a three-year period, for example:
- during this period in these three countries, importers of medicines from the UK will not need to hold manufacturing authorisations, nor will these medicines need to be batch tested again if they have already been tested in the UK
- In addition, Cyprus and Malta will be able, under certain conditions, and for justified public health reasons, to authorise the placing on their national market of a medicine authorised in the UK
- This will give operators more time to adapt. Work on a long-term permanent solution is ongoing in the context of the EU’s Pharmaceutical Strategy
- The competent authorities in the UK and the Member States concerned are required to to publish a list of the medicines in question. This is a way to increase transparency about the operation of the bespoke solution for Northern Ireland and the specific derogations for Cyprus, Ireland and Malta, with the ultimate aim of protecting public health in the EU and ensure that those medicines are not further distributed to other parts of the Single Market.
What will happen in the interim?
For the sake of stability and predictability, there will be an extension of the Commission’s interpretive note to ensure a continuation of the supply of medicines to Northern Ireland as well as Cyprus, Ireland and Malta. Existing arrangements will therefore last until the end of 2022*, unless the legislative procedure is finalised sooner.
*See Directive (EU) 2022/642 on derogations that apply until 31 December 2024.
Does the package cover veterinary medicines?
No, it does not cover veterinary medicines. Discussions on veterinary medicines will continue over the next months in order to gather information, identify any outstanding implementation issues and find the most appropriate way forward to ensure long-term continuity of veterinary medicines supply to Northern Ireland, as well as Cyprus, Ireland and Malta.
For the short term, however, the extension of the Commission’s interpretive notice includes veterinary medicines. Existing arrangements in this area will continue until the end of 2022*.
*See link for information on the extension of this arrangement to 31 December 2025.
What are the next steps?
The Joint Committee decision and recommendations will enter into force on 25 March 2023. Certain parts will become applicable in a gradual manner.
In order to fully implement the wide range of joint solutions announced in Windsor, the Commission tabled on 27 February, three legislative proposals, once of which concerns a regulation * on specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland.
Of significance in the regulation are the following::
- Prescription medicines in NI will not be permitted to carry the safety features required under the Falsified Medicines Directive (FMD).
- New novel medicines authorised by the EU (centralised medicines) will not be permitted on the NI market, i.e., only those authorised by the UK authorities will be permitted on the NI market.
- All medicines on the NI market must have the words “UK only” on the packaging.
- The provisions do not apply to veterinary medicines.
- The new provisions are due to be implemented from 1 January 2025. This date depends on when the UK provides written guarantees to the European Commission on the protection of the integrity of the EU internal market.
The Commission is working closely with the European Parliament and the Council for their swift adoption over the coming months.
The EU and the UK will work closely together, in good faith, to ensure the full implementation of the Windsor Framework, including the full implementation of safeguards and facilitations.
*Regulation (EU) 2023/1182 was adopted by the co-legislators on 14 June 2023 – reflecting a political agreement seeking to ensure a permanent solution for access to all medicine by people in Northern Ireland (NI). The regulation came into force on 21 June 2023. It shall apply from 1 January 2025, provided that the United Kingdom has provided the written guarantees referred to in Article 8 and that the Commission has published prior to that date the notice referred to in the fifth paragraph of this Article. You can read more about the regulation here.
HPRA Update on The Windsor Framework
1) On 25 May 2023, the HPRA published an update. It has very useful information under the following headings:
- Implications for Marketing Authorisation Holders (MAHs) supplying medicines to the Irish (IE) market
- Expiry of the existing exemptions in December 2024
You can view the HPRA update here.
2) On 6 December 2023, the HPRA published a Q&A document on the Windsor Framework. The document was updated and re-published on 19 June 2024, 3 October 2024 and 25 October 2024. You can view the latest version here. The document is based on questions the HPRA has received from companies and includes updated information on:
- Joint labels between IE/UK
- Medicines moving from Northern Ireland to the Republic of Ireland
- The expiry of Brexit Derogations approved in Ireland
Questions and answers to Stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use
The document with the above title which has practical guidance on the applicable rules to centrally authorised medicinal products for human use intended to be placed on the market in Northern Ireland before and after the application of Regulation (EU) 2023/1182, was published on 5 January 2024. You can view it here.
This document contains information on:
- Scope and applicability of Regulation (EU) 2023/1182
- Authorisation and supervision of medicinal products eligible to the centralised procedure to be placed on the market in Northern Ireland
- Transitional provisions
- Multi-country packs for centrally authorised products between Northern Ireland / UK and an EU / EEA Member State
- Update of the product information for centrally authorised products
- Marketing status reporting
- Parallel distribution
- Issues related to marketing authorisations and their procedures
Source: EMA
Further information
The Windsor Agreement and supply of medicinal products in Northern Ireland, Jackie Mulryne et al, 8 March 2023 Bioslice blog
Sources:
MHRA– Further information and publications (last updated on 28 July 2023 with new guidance links).
MHRA – Medicines announcement
HPRA – Questions and answers on the Windsor Framework, October 2024
Image by Christian Dorn from Pixabay