List of Disapplied EU SPS Laws (Northern Ireland)

The Windsor Framework includes an agreement between the EU and the UK, that will disapply a list of EU SPS rules to goods entering Northern Ireland in certain circumstances. I posted before about the Windsor Framework, more generally. The Windsor Framework amends the Ireland/Northern Ireland Protocol to the EU-UK Withdrawal Agreement.

The disapplication list is found in Annex 1 to the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on specific rules relating to the entry into Northern Ireland from other parts of the United Kingdom of certain consignments of retail goods, plants for planting, seed potatoes, machinery and certain vehicles operated for agricultural or forestry purposes, as well as non-commercial movements of certain pet animals into Northern Ireland.

The document is published as COM(2023) 124 final and Annex I is here. It is not yet law.

SPS is Sanitary and Phytosanitary.

The original Ireland/Northern Ireland protocol applied the same rules to agrifood trade between Cairnryan and Larne as between Holyhead and Dublin.

The Windsor Framework will set up a new “green lane” agrifood retail scheme. Part 2 of COM(2023) 124 final provides for the core elements of this “green lane” for agrifood retail movements to Northern Ireland. Part 2 is found here.

The “green lane” will allow traders moving agrifood goods to the final consumer in Northern Ireland to benefit from a unique set of arrangements that will enable an entire truck to move on the basis of a single certificate, without routine physical checks, and on the basis of UK food and drink safety standards.

The “green lane “ will be available to all such traders who are retailers, wholesalers, caterers, and persons providing food to public institutions like schools and hospitals.

Articles 4 and 5 (in Part 2) set out the requirements goods must meet in order to qualify for these unique arrangements. This includes products being prepacked and being made available only on the NI market for final consumers. The scheme is not limited to goods from Britain or the EU. Goods from the rest of the world can move under this scheme, either where they are processed in the UK, where they meet UK public health standards and pose no disease risk, or where disease risks exist and the UK has chosen to take the same approach to protecting against the same pests and diseases as the EU.

Products moved under the “green lane” scheme will be subject to UK and not EU rules for public health, marketing, organic, labelling, genetic modification, and drinks such as wines, spirits and mineral waters. Annex I sets out the list of EU rules that will be disapplied.

Product labelling will be introduced from October 2023 onwards.

Part 3 sets out the provisions for the movement of plants and plant products (other than seed potatoes) under the “green lane” scheme. These arrangements will be the same as those for plant movements within the UK.

Part 4 sets out the provisions for the movement of pets. Northern Ireland pet owners will therefore continue to move their pets to Ireland and the EU using the EU pet passport.

Article 11 removes the ban on movement of seed potatoes.

Cardinal Environment will identify the EU rules that will be disapplied for the “green lane” scheme, in Northern Ireland Registers & Checklists.

We will also highlight the disapplied EU rules in the REUL Deletion List which is supplied in every UK jurisdiction Registers & Checklists system.

Windsor Framework (Northern Ireland)

27th February 2023 saw political agreement reached between the EU and the UK on the Windsor Framework. The Windsor Framework is a set of new arrangements for agri-foods and medicines (and seeds, plants, trees and agri machinery; customs; VAT; and state aid) presently regulated by the Ireland/Northern Ireland Protocol of the EU-UK Withdrawal Agreement. Further information is in this UK command paper here.

The Ireland/Northern Ireland Protocol (known as the Northern Ireland Protocol or NIP in the UK) entered into force on 1st February 2020, and its provisions applied from 1st January 2021.

Agri-foods

A general single certificate will be used for mixed loads of agri-food goods consumed in Northern Ireland.

Identity checks will be reduced to 5% (for agri-foods consumed in Northern Ireland) – specifically – from 1 October 2023, the frequency rate of identity checks will be 10% of all consignments of retail goods for consumption in Northern Ireland), and 8% by 1 October 2024 when all milk and dairy products are individually marked. From 1 July 2025, the frequency rate will be 5% of all consignments of retail goods, when all retail goods are individually marked.

Physical checks (as respects agri-foods consumed in Northern Ireland) will be carried out in conjunction with identity checks using a risk-based and intelligence-led approach.

Documentary checks will be carried out on all the general certificates accompanying the consignments of retail goods for consumption in Northern Ireland. These checks can be performed remotely and electronically.

UK public health standards (e.g. level of additives in food) will apply to goods moved for end consumption in Northern Ireland. Previously prohibited chilled meats, such as sausages, will be allowed.

Certificates will not be needed for organics and wine (consumed in Northern Ireland).

Agri-foods originating in the rest of the world may enter Northern Ireland (for consumption in Northern Ireland) through Britain when UK conditions are identical to EU ones (specific list of products, including New Zealand lamb and vegetables).

The UK will provide EU representatives with access to relevant UK IT databases.

Labelling “not for EU” will be deployed for agri-foods consumed in Northern Ireland.

The movement of retail goods will be monitored, with traceability and listing of the dispatching and receiving authorised establishments.

Facilitations will be suspended to address specific problems or systematic failures of compliance with the new arrangements.

It will not be a dual regulatory regime. UK public health standards will apply to agri-foods entering Northern Ireland from Britain for consumption in Northern Ireland. But EU requirements for animal health and plant health in Northern Ireland will remain fully in place.

The UK announced in December that it will construct permanent SPS Inspection Facilities. Deployment of SPS Inspection Facilities will be gradual – 1 October 2023 for the delivery of enhanced facilities and 1 July 2025 for the delivery of final facilities.

Re “not for EU” labeling – from 1 October 2023, prepacked meat and fresh milk will be individually labelled. Goods sold loose need only to be labelled at box level (e.g. apples) and easily visible signs would need to be placed next to the price tag on the shelves in the supermarkets. Posters would also be needed, placed in the supermarkets so that consumers know that the goods are not for EU. As of 1 July 2025, all retail goods (other than goods sold loose) will be individually labelled except those not subjected to official controls at border control posts in the EU (e.g.: confectionery, chocolate, pasta, biscuits, coffee, tea, liqueurs, canned fruit and vegetables, ketchup and similar shelf-stable products).

Medicines

In April 2022, the EU amended its legislation to ensure the uninterrupted supply of generic medicines from Britain to Northern Ireland.

Novel medicines will be authorised and placed on the market in Northern Ireland in accordance with UK rules and UK authorisation procedures only. EU rules and authorisations will not apply to these medicines anymore. In addition, prescription medicines placed on the Northern Ireland market will not carry the EU required unique identifier/barcode to distinguish them from those placed on the EU market.

Individual packs of all medicines placed on the Northern Ireland market will be labeled “UK only”.

Stormont Brake

This is a new mechanism that will allow the UK government, at the request of 30 Members of the Legislative Assembly in Northern Ireland (Stormont), in the most exceptional circumstances, as a last resort as set out in a unilateral UK Declaration (statutory instrument to be debated next Wednesday in Parliament) to stop the application of amended or replacing provisions of NIP Retained EU law, that may have a significant and lasting impact specific to the everyday lives of communities in Northern Ireland.

The Stormont Brake is wider than Agri-foods and Medicines.

The UK Institute for Government has an explainer here.

Next Steps

A meeting of the Withdrawal Agreement Joint Committee will take place to adopt the necessary measures, translating the relevant joint solutions into legally binding commitments by making full use of its powers under the Withdrawal Agreement.

The European Commission has already made proposals to the Council for a Union position as regards, amongst other things, the decisions that need to be adopted in that meeting.

In addition, the Commission has also tabled three legislative proposals laying down, respectively, new rules for the movement of retail SPS goods, pets, seed potatoes, plants for planting and agricultural machinery from Great Britain to Northern Ireland, and rules giving effect to the solution found in the area of human medicines as well as certain categories of steel subject to tariff rate quotas. Once all translations are finalised, they will be transmitted to the European Parliament and Council. Once adopted and entered into force, the Commission will adopt any necessary implementing acts.

As identified earlier, the UK will debate next Wednesday in Parliament, a statutory instrument to give effect to the Stormont Brake.

EU Law Revocation (Northern Ireland)

I had earlier written that the REUL Bill does not apply to Northern Ireland. This is incorrect. As currently drafted, the Bill applies to Northern Ireland, and so it’s accommodation of the pre-existing Northern Ireland Protocol is not presently understood.

The Bill is back in Parliament today for its Third Reading in the House of Commons.

I will commence compiling the list of laws pertaining to Northern Ireland affected by the Bill. This will load onto subscribers Northern Ireland systems shortly, and updates included in the monthly Email Alerts. This list will also identify those of the cohort also listed in the Northern Ireland Protocol. If a document is listed in the Northern Ireland Protocol, it also applies in Northern Ireland, even if identified for deletion under the Bill.

Note: the list pertaining to Britain and the devolved administrations in Britain (Scotland and Wales) is already loaded onto subscribers systems for these jurisdictions.

I will Blog post again, if the Government accepts any amendments arising from the Report stage, being debated later today.

The later stages in the Lords (of enactment of this Bill) could also make amendments, that may or may not be accepted by the Government. Further Blogs on the matter can be expected.

SPS Border Posts Construction (Northern Ireland)

The UK Government has enacted The Official Controls (Northern Ireland) Regulations 2023, in force on 2nd February 2023.

These Regulations make provision allowing the Secretary of State to implement specific elements of Article 64 of European Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, in Northern Ireland.

The EU document applies in Northern Ireland by virtue of the Withdrawal Agreement.

Regulation 3 provides that the Secretary of State may do anything that the Secretary of State considers appropriate in connection with the construction of facilities for the purpose of performing official controls.

It also makes provision for the Secretary of State to direct the competent authority in Northern Ireland to recruit and employ staff to implement Article 64 in Northern Ireland.

As a result, border post construction for the purposes of SPS checks on goods likely to cross the border into the EU (on the island of Ireland) can be expected to commence.

EU-UK Withdrawal Agreement Joint Committee (Northern Ireland)

The EU-UK Withdrawal Agreement (an international agreement) is overseen by a Joint Committee of the parties. This Joint Committee holds regular meetings, the last meeting was in June 2021. Specialised Committees operate under the auspices of the Joint Committee, these also meet regularly. The last meeting of the Specialised Committee for the Withdrawal Agreement Ireland/Northern Ireland Protocol was in September 2021. The EU tracks these meetings here. The UK tracks these meetings here. You will notice that the statements made re the Ireland/Northern Ireland Protocol are not Joint Statements. This is the case also re Gibraltar.

The next meeting of the Joint Committee is next week, but the agenda is not published.

Meanwhile, the Northern Ireland Executive is not operating (this has happened before). An executive order to stop checks on goods moving from Britain to Northern Ireland is stayed by the Northern Ireland High Court pending a decision of a Judicial Review of that order due early March (in 2021 the Northern Ireland High Court quashed a similar order). Also May is a month in which elections to the Northern Ireland Assembly are scheduled.

In advance of the Joint Committee meeting next week, Irish and EU representatives are discussing matters with Northern Ireland political parties, business and civil society representatives. Checks on goods moving between Britain and Northern Ireland are continuing. In the absence of a Northern Ireland Executive, civil servants will attend the Joint Committee.

The Joint Committee may also consider other matters (the Withdrawal Agreement has other protocols, and five Specialised Committees). The agenda will give more information.

I will update this post (on the blog platform) after the Joint Committee meeting.

Further Border Control Delays (UK)

The UK government recently announced that movement of goods from GB to Northern Ireland (occurring under the grace arrangements in the Northern Ireland Protocol – NIP) would continue in the current manner indefinitely.

The UK government also recently announced that CE marked goods would continue to circulate in GB for the entire 2022. CE marked goods circulate in Northern Ireland by virtue of the NIP. This was included in the August Email Alert.

This morning, the UK government confirmed – here

• The requirement for pre-notification of agri-food imports will be introduced on 1 January 2022 as opposed to 1 October 2021.

• The new requirements for Export Health Certificates, which were due to be introduced on 1 October 2021, will now be introduced on 1 July 2022.

• Phytosanitary Certificates and physical checks on SPS goods at Border Control Posts, due to be introduced on 1 January 2022, will now be introduced on 1 July 2022.

• The requirement for Safety and Security declarations on imports will be introduced as of 1 July 2022 as opposed to 1 January 2022.

The timetable for the removal of the current easements in relation to full customs controls and the introduction of customs checks remains unchanged from the planned 1 January 2022.

EU further detail re NI Protocol (Northern Ireland)

The EU issued (a few days ago) a set of non-papers that give further detail on its proposals for changes to its Single Market rules to ease movements between NI and GB under the Ireland/Northern Ireland Protocol (a schedule to the UK-EU Withdrawal Agreement).

The first set deals with sanitary and phytosanitary (SPS) – here.

(1) re guide dogs (assistance dogs) – European Commission’s services had clarified (some time ago) that assistance dogs accompanying their owner when entering the EU territory and Northern Ireland, may benefit from the flexibility offered by Article 32 of Regulation (EU) No 576/2013 on the non- commercial movement of pet animals.

The above was recalled in the technical meetings the EU held with the UK Cabinet Office and the British DEFRA ministry, especially those held on 27 April and 12 May 2021, where the UK side confirmed that the Northern Ireland ministry DAERA would propose an operating procedure for the practical implementation of Article 32.

DAERA updated its guidance on 2 June 2021 – here.

(2) re identification and re-identification of cattle, sheep and goats – the document points out that EU rules on traceability of terrestrial animals require that certain species (bovines, ovines, caprines, camelids and cervids) shall be individually identified on the establishment where they are born. The same requirement applies to animals of those species when they enter into the Union from a non-EU country; those animals have to be individually identified at the establishment of arrival.

Under the EU animal health legislation (Delegated Regulation (EU) 2019/2035), bovine, ovine and caprine animals need to be identified with an eartag bearing a code as laid down in Implementing Regulation (EU) 2021/520 so that the first element of the identification code is the country code of the Member State where the means of identification was first applied to. The country code can be either a two-letter code (mirroring ISO standard 3166-1 alpha-2) or a three-digit country code (ISO standard 3166-1 numeric).

The EU has now issued Implementing Regulation (EU) 2021/1064 to provide that ‘XI’ is the two-letter code to be used in United Kingdom in respect of Northern Ireland and the three-digit code assigned is ‘899’.

–  New-born animals in NI after 01/07/21 should bear the “XI or “899” code in their eartags;

–  Animals introduced from third countries (or GB) into NI after 01/07/21 and identified not in accordance with EU rules (e.g. bearing a UK code) should be re-identified with eartags bearing “XI” or “899” establishments of the first arrival;

–  Animals introduced from third countries (or GB) into NI already identified in accordance with EU rules (e.g. bearing a XI code) do not need to be re-identified.

It must be remembered that EU Animal Health Law already moved on since 31st Dec 2020.

(3) re re-entry of animals for exhibitions/events – the document points out that EU animal health legislation (Delegated Regulation (EU) 2020/692) stipulates ungulate animals (except racing horses) to be introduced into the EU have to fulfil all the requirements and respect a residency period of 6 months in an authorised third country of origin for such imports.

To enable the participation of EU animals in events, exhibitions or shows, the Commission has drafted an amendment to Delegated Regulation (EU) 2020/692 to set up for certain species of ungulates (bovine, ovine and caprine animals) :

* a derogation from certain general requirements, including from the 6 months residency in the “guest” country;

* minimum specific animal health requirements for the re-entry into the Union of those animals:

–  they are moved for a period not exceeding 15 days to participate in events, exhibitions;

–  the third country is listed for the entry into the EU of cattle, sheep, goats;

–  the establishment complies with the requirements for assembly operations of ungulates;

–  the transport is direct and in appropriate vehicles;

–  the animals do not have contact with animals of a lower health status during the stay in the third country.

In addition, the Commission has drafted a new legal text (amending Implementing Regulation (EU) 2021/403 as regards the new model certificate and amending Regulation (EU) 2021/404 as regards the list of third countries authorised) to lay down:

–  a specific model certificate for entry into the EU of those animals reflecting the requirements described above;

–  the list of third countries authorised for this special re-entry into the EU of animals which took part to such events.

(4) re animal products that originate in the Union and move to a third country and then move back again after unloading, storage and reloading in that third country

The document states that animal health policy for entry into the EU of products of animal origin does not allow third countries to certify for import into the EU products which have been imported in that third country, including products of EU origin.

Therefore, the EU’s Implementing Regulation (EU) 2020/2235, which establishes the model certificates for entry into the EU of products of animal origin, does not include any model certificate to cover the entry into the Union of products of animal origin which originate in the EU and which are moved to a third country or territory, and are then moved back to the Union from that third country or territory after unloading, storage and reloading.

The lack of such certificate model would prohibit EU products of animal origin to re-enter the EU after being stored in a third country.

The Commission has drafted a new Implementing Regulation amending Implementing Regulation (EU) 2020/2235 to add a model certificate for that purpose. This will allow re-entry into the EU of products of EU origin which are packaged and stored under the control of the competent authority of the third country.

The change will also amend Annex XXII to Implementing Regulation (EU) 2021/404 to establish a list of third countries that are authorised to use that certificate (including GB and the Crown Dependencies).

A separate non-paper addresses medicines – here.

This document points out that medicines placed on the market in Northern Ireland (NI) must be covered by a valid marketing authorisation issued by the Commission (EU-wide authorisations) or the UK for NI in applying the Union legislation for medicinal products listed in Section 20 of Annex 2 to the Ireland/Northern Ireland Protocol (UK national authorisations).

The Protocol provides for two possible UK national authorisation routes: purely UK national authorisations (“NI-only authorisations”), which concern medicines that are made available in NI only, and UK national authorisations granted via the Mutual Recognition or Decentralised Procedures (MRP/DCP), which is mandatory.

European Commission Notice of 25 January 20212 provides for a grace period of one year (until end-December 2021) for maintaining batch testing and manufacturing / logistics in Great Britain (GB) to ensure undisrupted supply of medicines to NI and those EU Member States (Cyprus, Ireland and Malta) that have been historically dependent on medicines supply from or through GB.

Bear in mind that medicines supply in Northern Ireland is the responsibility of the UK authorities, not the EU.

The EU is now proposing that regulatory compliance functions may exceptionally be located in UK (GB) in respect of medicines covered by any national authorisations issued by the UK authorities in respect of NI, provided that the following conditions are met:

a. the UK fully applies the relevant Union legislation on medicines: on quality, safety, efficacy, pharmacovigilance and batch testing and release when issuing national marketing authorisations in respect to NI;

b. the marketing authorisation contains a legal prohibition of sale (resale) outside its geographical scope: medicines with an authorisation for UK(NI) cannot be legally sold anywhere else in the EU and the specific authorisation code for NI is stamped on each pack;

c. the safety features required under applicable Union law are placed on each pack ensuring that medicines can only be sold in conformity with a valid marketing authorisation in NI;

d. the UK ensures and demonstrates the correct implementation/application of the Falsified Medicines Directive in respect of NI. The EU end-to-end verification system must generate an alert if a medicine specifically authorised for NI is scanned elsewhere in the EU Internal Market;

e. enforcement and supervision by the UK competent authorities on economic operators and regulatory compliance activities located in GB are carried out in accordance with applicable Union law.

The document sets out additional requirements.

Information on the EU’s controls on medicines for human use is – here.

Bear in mind that the UK has signed up to the separate (non-EU) Project ORBIS and the MHRA has issued its first authorisation – here. I wrote a blog post about this at the time.

Bear in mind that the BGMA has issued a press release about withdrawal of medicines a few days ago – reported by the BBC – here. The BGMA press release is – here.

EU announcements re NI Protocol (Northern Ireland)

The Protocol on Ireland and Northern Ireland (often referred to in the UK as the Northern Ireland Protocol), as an integral part of the EU-UK Withdrawal Agreement, was agreed jointly and ratified by both the EU and the UK. It has been in force since 1 February 2020 and has legal effects under international law.

The EU has announced the following re Northern Ireland (as respects the NI Protocol):

(1) the EU extends the non-application of third country rules (grace period) for meat products to 30th September (1st October is the date when the UK will apply its own ban on chilled meat imports) – the EU declaration is here – the UK declaration is here.

This will mean that meat products can continue to move from Britain (a third country in EU terms) to Northern Ireland (a part of the UK subject to the NI Protocol).

This temporary solution is subject to strict conditions. For example, the meat products that are subject to the channelling procedure referred to in the United Kingdom’s unilateral declaration must remain under the control of the Northern Ireland competent authorities at all stages of that procedure. These meat products must be accompanied by official health certificates issued by the UK competent authorities, can exclusively be sold to end consumers in supermarkets located in Northern Ireland, and must be packed and labelled accordingly. (EU declaration)

(2) the EU will change its own rules so that regulatory compliance functions for medicines authorised by the UK for the Northern Ireland market, in accordance with the NI Protocol, may be located in Britain, subject to specific conditions ensuring that the medicines concerned are not further distributed in the EU Internal Market – the European Commission will put forward a legislative proposal in the early autumn (the grace period runs out at the end of 2021)

(3) the EU will facilitate the movements of guide dogs accompanying persons travelling from Britain to Northern Ireland – this is communicated to the UK authorities and it is for the Northern Irish competent authorities to define the details for its implementation on the ground

(4) the EU waives the obligation to show the motor insurance Green Card for drivers from the UK – applicable for Northern Irish motorists crossing the border into Ireland (not for British motorists travelling to Ireland)

(5) the EU has removed the need for re-tagging when animals move multiple times between Britain and Northern Ireland during their life – the European Commission adopted an implementing act to that effect on 29 June 2021 (Commission Implementing Regulation (EU) 2021/1064).

The EU also announces the European Commission is working on a regulatory solution to facilitate the swift return of livestock to Northern Ireland from exhibitions or trade fairs in Britain, so that the animals concerned will not have to wait for a minimum residency period in Britain – the relevant delegated and implementing acts will be adopted in October 2021.

The EU also announces work is ongoing on a solution regarding the risk control of scrapie, to facilitate the movement of sheep and goats between Britain and Northern Ireland.

EU Eco-design & labelling rules (Britain)

The UK government has decided to introduce EU Ecodesign and Energy labelling rules for lighting products in Britain in 2021 (if there is parliamentary time).

The UK government decision is set out here, and here.

In the EU from 1 September 2021, the existing rules under Regulation (EU) No 874/2012 will be repealed and replaced by new energy labelling requirements for light sources under Regulation on energy labelling for light sources (EU) 2019/2015. 

The new EU rules will use a scale from A (most efficient) to G (least efficient), the new labels will give information on the energy consumption, expressed in kWh per 1000 hours and have a QR-code that links to more information in an online database.

In the EU, with the new regulation, most halogen lamps and the traditional fluorescent tube lighting, which are common in offices, will be phased-out from September 2023 onwards.

Note : the UK government earlier decided to rescale the energy labels for some energy-related products from 1 March 2021, following the EU. The legislation is not yet adjusted. The Office for Product Safety and Standards (OPSS) issued technical notices, and the UK government updated the information on gov.uk and responded to email queries from businesses. I blog posted at the time about this change. The updated guidance is found in the Brexit Guidance List on subscribers’ Cardinal Environment Limited EHS Legislation Registers & Checklists.

Note (2) : the EU rules will apply in Northern Ireland by virtue of the Northern Ireland Protocol.

First Project Orbis Cancer Treatment Authorisation (UK)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has just announced its first authorisation (of a post-surgery lung cancer treatment) under Project Orbis.

Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) to review and approve promising cancer treatments.

It involves the regulatory authorities of:

• Australia (TGA)

• Canada (Health Canada)

• United Kingdom (MHRA)

• Singapore (HSA)

• Switzerland (Swissmedic)

• Brazil (ANVISA)

The UK joined Project Orbis on 1 January 2021 following its departure from the EU (and the European Medicines Agency with the ending of the Brexit transition period on 31 Dec 2020). While the FDA serves as the primary coordinator for application selection and review, Project Orbis Partners (POPs) may propose products for inclusion in the scheme. Each country remains fully independent on their final regulatory decision. Applications submitted to the MHRA within a Project Orbis procedure are national (Great Britain only) marketing authorisation applications and variations.

Per the MHRA press release – Osimertinib (Tagrisso), a medicine made by AstraZeneca, is a licensed treatment for patients with mid and later stage non-small cell lung cancer (NSCLC) who test positive for a specific gene mutation called EGFR. EGFR mutations occur in approximately 12% of lung cancer patients. The licence has now been extended to include a new population of patients in early-stage disease. The extended licence offers a novel treatment option for these patients, after their cancer has been surgically removed, in an area of significant unmet need.

NHS England, NICE (the National Institute for Health and Care Excellence) and AstraZeneca have reached an agreement to enable early access to osimertinib for early-stage lung cancer patients in England on a budget-neutral basis to the NHS while NICE undertakes its appraisal.

The MHRA press release is here. The press release sets out further detail.

Please note different Medicines supply stipulations apply in Northern Ireland from 1 Jan 2021 – here.