2. Trade in Goods
2.1. Trade in Goods
From 1 January, 2021, regardless of the outcome of the ongoing negotiations, the UK will no longer be part of the EU’s Single Market and Customs Union. This means any business that moves goods from, to or through the UK will be subject to a range of new customs formalities, SPS checks and other regulatory requirements, that do not apply in any form today to such trade.
The main elements of these changes are set out below but it is vital that businesses, no matter how small, take steps to understand the impacts any new rules or processes will have on your operations. Failure to engage with and implement these new requirements will prevent you from trading with the UK or could lead to significant delays in moving goods from, to or across the UK from 1 January next.
It is also important to note that these changes will not apply with respect to trade in goods between Ireland and Northern Ireland where the Protocol on Ireland and Northern Ireland will apply from the end of the transition period, regardless of the outcome of the ongoing EU-UK negotiations. Under the Protocol, the Union Customs Code will continue to apply to and in Northern Ireland. Unless otherwise stated, references to imports from or exports to the UK in this section should be read as excluding trade with Northern Ireland.
The UK government has published plans for a new range of checks and controls. Information sources on these requirements can be found in Section 2.1.8 below.
2.1.1. Customs Processes for imports from, and exports to, Great Britain2
From 1 January 2021, all goods imported into Ireland from Great Britain or exported from Ireland to Great Britain will be subject to customs processes. The critical first step in terms of Brexit readiness is to register for an EORI (Economic Operators Registration Identification) number. Revenue has written to over 100,000 companies since 2019 including over 57,000 in July 2020 who traded with the UK but had not yet registered for an EORI number. Over 67,000 businesses now have an EORI number (these businesses account for 96.4% of the value of exports to the UK in 2019 and 93.3% of the value of imports).
Once a business has an EORI number it will need to decide if it plans to do the customs work itself or to engage a customs agent. If doing the customs work in-house, the business will need the necessary software and be able to connect to Revenue’s customs systems. More detail on electronic customs systems and information on the technical requirements for customs is available on Revenue’s website.
2 Goods transiting the UK via the Landbridge will also be subject to new procedures which are dealt with separately in Section 2.2
A business planning on undertaking this work in-house may be eligible for government support. The July Jobs Stimulus made a €20 million Brexit package available including ‘Ready for Customs’ grants for businesses involved in exporting and importing with the UK to put in place the necessary internal arrangements, staffing, software, and IT systems. The Governments Clear Customs Online scheme, delivered in partnership with industry and fully subsidised, covers a range of customs and SPS requirements. The programme is open for applications from September on the Skillnet Ireland website and is delivered primarily through an online platform, thus reducing disruption for businesses. Local Enterprise Offices will undertake a further round of their ‘Prepare for Customs’ Training programmes with information available on the Local Enterprise Office website, and Enterprise Ireland also provide a Customs Insights Course, which is available via their ‘Prepare for Brexit’ website. Bord Bia’s Customs Readiness Programme and bespoke Mentoring Programme is available to upskill food and drinks manufacturers, and further advisory guidance is also outlined in Bord Bia’s Brexit Action Plan.
Certain businesses may wish to consider becoming an Authorised Economic Operator (AEO). This authorisation recognises reliable operators as ‘trusted traders’ and can offer various benefits. Additionally, there are some simplified customs procedures that allow businesses to import goods and to perform customs formalities more easily. This includes the facility to defer payment of import charges or claim total or partial relief from import charges. You can find further information on how to apply for these authorisations on the Revenue website.
2.1.2. Supply Chain and Origin of Goods
From the end of the transition period, and without prejudice to any arrangements that may be put in place in an EU-UK future partnership agreement, UK (including Northern Ireland) products or materials will no longer be considered as EU originating for the purposes of international trade.
Before 1 January, 2021, it is important that a business understands where its goods originate, the value of the goods, the customs classification code and invoicing currency. In considering the origin of goods, it is necessary to review both the material inputs and processing operations.
The country of origin of goods is a factor in determining the amount of duty payable and must be proven for goods to benefit from preferential treatment. Goods imported from the UK that do not meet origin requirements will be liable for customs duties even if the EU and UK agree a zero tariff, zero quota EU-UK trade agreement.
The change in status of UK origin will also impact Irish businesses who use UK inputs when availing of the benefits of EU FTAs with other FTA partner countries. Irish exporters should review and, if necessary, adjust their supply chains so that products meet the thresholds required to avail of preferential rates under EU Free Trade Agreements with non-EU countries. This may include countries that have concluded an FTA with the UK, depending on the terms of that agreement. Furthermore, to maintain preferential originating status, goods will also have to meet any direct transport/non-alteration provisions (i.e. the goods must travel directly between the countries party to the FTA or be under customs control if they transit through a third country). Further details are available on Revenue’s website.
2.1.3. Import Duties (Customs Duty, VAT and Excise)
Consideration is required on the impact that import duties may have on your cash flow. You can register with ROS (Revenue’s Online Service) in order to lodge funds into your customs account and also to apply for deferred payments until the month following import. See Revenue’s website for further information.
VAT will be chargeable on goods imported into Ireland from the UK while exporters must be able to prove that the goods left the Union in order to apply the zero rate of VAT applicable to exports. If a business uses any EU VAT simplifications such as triangulation or self-billing, these will no longer be available where part of the transaction occurs in the UK. Similarly, the European VAT Refund (EVR) system will no longer be available to reclaim VAT expended or refund VAT charged in the UK.
In order to address the significant impact these VAT changes will have on businesses Part 8 of the 2020 Brexit Omnibus Bill provides for the introduction of postponed accounting for VAT for most VAT registered companies. Under the proposed system, importers will not pay import VAT at the point of entry but will instead account for it through their bi-monthly VAT return. Revenue will be granted powers to remove this facility from traders that pose a risk to Revenue. The VAT treatment of supplies of goods to Northern Ireland after the end of the transition period will not change.
Once the UK becomes a third country at the end of the transition period, excise duty will be incurred when excisable goods such as alcoholic beverages or tobacco are imported into the EU from the UK. As a third country, a Duty Free and VAT Retail Export Scheme may also operate between Ireland and the UK (excluding Northern Ireland). The 2020 Brexit Omnibus Bill includes a number of measures relating to duty free sales and the application of any VAT Retail Export Scheme to UK Residents. Further information on the 2020 Brexit Omnibus Bill can be found at Section 1.5.
Brexit may also impact the logistics model used by a business. Businesses, including haulage and logistic companies, should be familiar with all documentation that will be required for moving goods between Ireland and Great Britain from the end of the transition period, and should engage immediately with their logistics provider to that end. Hauliers will not be able to board ferries to and from Great Britain from 1 January 2021 unless all documentation has been completed in advance and properly presented.
2.1.5. EU Single Market Accreditations, Certifications and Market Surveillance for Goods/Products
From 1 January 2021, UK notified bodies will no longer be authorised to certify the compliance of products with EU rules and standards in respect of specific regulatory controls, public safety and health. For businesses that currently rely on UK Notified Bodies for conformity assessment certificates, it is vital to source an alternative approved Notified Body established in the EU. This may involve transferring existing certificates to a Notified Body in another EU Member State or obtaining new ones altogether. The Government acknowledges that many businesses have already taken the necessary steps to address this issue. Companies that source products, requiring EU certification, from the UK should engage with their EU-based Notified Bodies. The European Commission’s NANDO website also provides a list of designated EU Notified Bodies as well as a list of Irish-based Notified Bodies.
Importers of products/ingredients that require organic certification should ensure that the certifying body of the UK product has been recognised by the EU Commission. Companies exporting to the UK should check the UK Government website and the information in the “UK
Other impacts in this area that businesses may wish to consider include requirements to register products on EU databases; requirements to be established in the EU (which will no longer include the UK) and requirements relating to the marking and labelling of goods.
In relation to industrial products (including construction products), manufacturers, distributors, importers and authorised representatives must comply with their obligations and responsibilities under EU product legislation when placing a product on the EU market. For example, an economic operator established in the EU who, prior to the end of the transition period, was considered as an EU distributor of products received from the UK will become an importer for the purposes of EU product legislation in relation to such products as of the end of the transition period. This operator will have to comply with the more stringent obligations applicable to an importer.
A number of state agencies undertake an important market surveillance role to ensure products are designed, manufactured and monitored in accordance with EU law and can provide advice in relevant sectors. This includes agencies such as: The Health and Safety Authority (HSA), the Competition and Consumer Protection Commission (CCPC), the National Standards Authority of Ireland (NSAI), the Environmental Protection Agency (EPA), the Sustainable Energy Authority of Ireland (SEAI), and the Building Control Authorities and National Building Control Office (NBCO). Further information on market surveillance is available in the Government’s Market Surveillance Plan for Ireland (2019).
2.1.6. Customs Roll-On Roll-Off Service
Revenue has developed the Customs Roll-On Roll-Off Service, accessible via the Revenue website, which provides three functions that facilitate the flow of commercial vehicles into and out of Irish ports and supports the just-in-time business model preferred by many businesses. The functions are:
- Pre-Boarding Notification – in order to move goods quickly through Irish ports customs declarations should be made in advance of arrival at the port of departure in the UK. The details of customs declarations for all goods to be carried on a vehicle/truck need to be recorded in the Pre-Boarding Notification (PBN). The PBN is a virtual envelope that links together the details of all of the goods being carried on a vehicle/truck. This enables customs to provide one single instruction to be followed by the driver on arrival at an Irish port, regardless of the number of consignments on board the vehicle, ensuring speedy and accurate channelling of a vehicle/truck through the port.
- Channel Look-Up – provides information on whether a vehicle can directly exit the port or if the goods need to be brought to customs for checking. This information will be made available via the Customs RoRo Service 30 minutes prior to arrival of the ferry into Ireland and can be accessed by anyone in the supply This will facilitate the efficient flow of traffic through our ports. It will also assist business from a planning perspective knowing which vehicles and consignments are on their way out of the port.
- Parking Self Check-In – drivers whose vehicles have been called for a physical inspection will be able to remain in their vehicle and inform Revenue that the goods are available for inspection using this When an examination bay becomes available the driver will receive a text message advising him/her where to attend for inspection. This will minimise the need for face to face interaction between the driver and Revenue staff and speed up procedures overall.
Businesses will need to consider who will complete the Pre-Boarding Notification, this may or may not be the same person that lodges the customs declarations. A business will need to consult with its logistics provider to determine what will work best, having regard to the business model.
2.1.7. Importing or Exporting Animals, Plants, and Products of Animal and Non-animal Origin.
If you want to import or export animals, plants, or products of animal (including fish) or plant origin from or to the UK (excluding NI) from 1 January 2021 you must be registered with the Department of Agriculture, Food and the Marine. Furthermore, importers will also need to be registered on TRACES (an EU Commission system for the electronic completion of documentation required for imports of certain consignments from third countries).
Further information on the registration processes, and more generally in relation to importing and exporting animals, plants, and products of animal and plant origin (including fish) from or to the United Kingdom (excluding NI) from 1 January 2021 can be found on the Department of Agriculture, Food and the Marine website. You should contact firstname.lastname@example.org in relation to queries regarding registration with DAFM and TRACES.
The trade of certain seafood products is also subject to additional requirements – more information on this can be found on the Sea-Fisheries Protection Authority’s website.
You may also need to register with/notify the Environmental Health Service (EHS) of the HSE in relation to the import and export of food products of non-animal origin. If an export certificate is required for foods of non-animal origin or a food business wishes to notify the HSE, this facility is available through the EHS online services.
For queries in relation to export certificates for foods of non-animal origin, please contact email@example.com. For queries in relation to import controls, please contact firstname.lastname@example.org or email@example.com as appropriate. For all high-risk food of non-animal origin, importers will need to register on TRACES.
2.1.8. New UK checks and controls
On 13 July 2020, the UK Government published its Border Operating Model, outlining plans for the introduction of border controls on exports to Great Britain from the EU. These plans indicate that controls will be implemented in three phases, from 1 January 2021 and with full controls implemented by July 2021. In addition to outlining the various elements that come on line in each phase, the paper also provides details of the models that will be used at border locations, various IT platforms for the RoRo Freight sector such as the new Goods Vehicle Movement Services and the Smart Freight System, as well as details for moving excisable goods and VAT.
It is important that businesses trading with Great Britain, or using the landbridge across Great Britain, make themselves aware of their responsibilities in relation to UK customs and regulatory checks and controls. In particular, it will be necessary to be aware of the introduction of controls on a phased basis in January, April and July.
Because of the Protocol on Ireland and Northern Ireland separate arrangements apply on the island of Ireland and no new checks or controls will apply to goods moving between Ireland and Northern Ireland in either direction.
2.1.9 Trade in Goods – Actions
This section should be read in conjunction with the advice on business supports in Section 1.3 and with the information in Section 1.2 on Government communications and stakeholder outreach.
Businesses should now:
- Register for an EORI (Economic Operators Registration Identification) number through the Revenue website, if you haven’t already done
- Where appropriate, consider applying for a customs authorisation such as Authorised Economic
- Give urgent priority to examining your supply chain and decide if you will undertake customs work yourself or if you will use a customs
- If doing this work yourself (i) install the necessary software to enable you to connect to Revenue’s IT systems; (ii) familiarise yourself with the process for making import declarations through Revenue’s Automated Import System (AIS) (which will be available from November) and /or export declarations which are submitted to the Automated Entry Processing (AEP) System which is now
- Avail of the Government’s training and financial supports including Clear Customs Online 2020 and the ‘Ready for Customs’ grant of up to €9,000 including a contribution towards recruitment and related software and IT
- If moving your goods by ferry make preparations to comply with the Pre-Boarding Notification
- Understand the new checks and controls that will be introduced by the UK Government (see section 1.8).
- Consult with your UK/GB suppliers or customers to confirm that they are also aware of and prepared for the changes that will come about when the transition period ends
- In addition, if importing or exporting live animals, plants, or products of animal (including fish) or plant origin, register with the Department of Agriculture, Food and the Marine
2.2. UK Landbridge
The UK landbridge refers to the route that connects Ireland to the EU Single Market and wider international markets via the UK’s road and ports network. Maintaining the landbridge as an effective route to market has been a key priority of the Government’s Brexit planning. The Irish Marine Development Office estimate that there are approximately 150,000 landbridge movements annually with an estimated value of this trade of €18.2 billion. A significant proportion of goods using the landbridge are agri-food goods, such as fresh fish, with a short shelf life, making the UK landbridge the most viable route to market.
Post-transition, operators will still be able to move goods via the landbridge but the way they use the landbridge will change. The UK’s accession to the Common Transit Convention (CTC) is welcome. This allows EU goods to move under transit through the UK without undergoing full customs import and export formalities on entry and exit. However, to avail of the benefits of the CTC, there will be certain new requirements including new paperwork as well as the need for each consignment to have a financial guarantee in place to cover the potential customs duties and other taxes at risk during the movement. In addition, operators should be aware that customs and border controls on wider goods traffic using the same port infrastructure along the landbridge brings the risk of significant delays and increased transit times.
Operators using the UK landbridge will need to be aware of and implement the provisions set out in the UK’s Border Operating Model. While some controls under the model will be introduced on a phased basis, traders moving goods using the Common Transit Convention will need to follow all of the transit procedures from 1 January 2021 as these will not be introduced in stages. The UK’s goods vehicle movement service (GVMS) will be introduced from January for transit movements.
Ireland has undertaken substantial engagements at political and official level across the EU to ensure that EU goods moving under transit via the landbridge are not subject to additional and unnecessary checks and controls. In particular, we have worked closely with our French, German, Dutch and Belgian counterparts to understand each other’s operations and plans post transition. The overarching aim has been to ensure that, once the correct paperwork is in place, the necessary controls are completed, and transit goods will be “green lighted” and permitted to leave ports. To facilitate this, transit declarations will need to be submitted electronically by traders in advance and the required financial guarantees will also have to be in place. Any checks that are carried out today (such as on live animals) will continue. Ireland supports appropriate checks to ensure the integrity of the Single Market and public health. We will also continue to work with the European Commission and Member States to address SPS challenges that arise in light of the introduction of the new Official Controls Regulation (OCR). The solution currently proposed by the Commission helps to address the concerns arising for Ireland and other Member States. From an Irish perspective, the positive and solution-oriented approach taken by the Commission is very welcome.
As new systems and processes are brought on line in ports across the EU and UK, the risk of queues and delays, some of which may be very substantial in busy ports is high. The Dover- Calais crossing has been identified as a particular bottleneck. It is also possible that Holyhead will experience similar congestion in the initial period after transition ends. In order to benefit from the work done to mitigate delays in EU ports, it will be important to have the appropriate administration work, including the requirement to have a financial guarantee in place. More traders and hauliers with correct paperwork will reduce delays in ports. Traders should also familiarise themselves with any changes underway in ports of transit in the UK and at destinations including Dublin Port and Rosslare Europort.
Traders may also wish to look at direct route options. The process for moving goods directly between Ireland and other EU Member States will not change nor be subject to the new procedures highlighted in this section.
2.3. Agri-Food and Fisheries
The agri-food and fisheries sector is one of the most exposed to the impacts of Brexit. This is due to a number of factors, but primarily its exposure to the UK market and the requirement for sanitary and phytosanitary (SPS) controls to be conducted on movements of animals, plants and products of animal and plant origin between the UK and Ireland from January 2021. The sector is a primary driver of rural and coastal economies, and data shows that rural areas, including the border region, are more exposed to a slowdown in the agri-food sector.
Ireland exported €5.47 billion of agri-food produce to the UK in 2019, which represents 38% of the total Irish agri-food exports in 2019. Our agri-food sectors are highly exposed, particularly the beef sector; 43% of our beef exports in 2019 went to the UK. These are also the sectors that are exposed to the highest potential trade tariffs that could arise in the post- Brexit trading environment if negotiations prove unsuccessful. In such a scenario, in addition to the application by Ireland of the EU’s Common External Tariff Regime to UK imports which were worth €4.6 billion in 2019, the UK’s Global Tariff Schedule (published in May 2020) would apply to Irish exports to Great Britain. Based on an analysis of 2019 agri-food export data, this would see a total estimated tariff cost of between €1.35 and €1.5 billion. Although all sectors will be impacted, the magnitude of that impact of the UK Global Tariff Schedule will result in beef, dairy, pigmeat, poultry and cereals incurring the highest cost in absolute terms. The reliance of each sector on the UK export market varies with beef the most exposed. Accordingly, the Government strongly supports the European Union’s objective to agree a tariff-free and quota-free trading arrangement.
A range of financial and budgetary measures for the agri-food and fisheries sector over the last four years were aimed at enhancing competitiveness and market and product diversification. These included low cost loan schemes, supports for Bord Bia and Teagasc, direct aid for farmers, capital funding for the food industry, and an intensified series of Ministerial-led trade missions to develop and grow new markets in light of Brexit. Further targeted measures to support businesses and the most-affected sectors will be considered in the context of Budget 2021. Bord Bia provides a range of tailored supports and analysis for the food and drinks sector, including a Customs Readiness programme, supply chain workshops and a bespoke Mentoring Programme. Bord Bia’s Brexit Action Plan provides useful advice and assistance, while further guidance on business supports more generally can be found Section 1.3 of this Action Plan.
Regardless of the outcome of the trade negotiations, change will arise for the Irish agri-food industry from 1 January 2021. The UK’s status as a third country brings new customs and regulatory requirements for importers and exporters of agri-food products. As required by EU legislation, new SPS requirements in the form of documentary, identity and physical checks on imports of animals, plants and products of animal (including fish) and plant origin will be applied to trade with Great Britain. While SPS checks are important to ensure food safety and protect consumers, they will also increase the cost of trade and result in delays in the movement of goods, although every effort will be made to ensure the minimum possible disruption to trade flows.
Export certification and other requirements in respect of movement of goods to Great Britain will also arise, and the Irish Government will closely monitor the evolving UK position in this area and ensure necessary contingency measures are in place.
Irish fishing vessels that land directly into ports in Great Britain will be subject to additional IUU requirements from 1 January 2021. Vessels will only be able to land into ports designated by the UK for third country landings and will have to notify the UK competent authorities at least four hours in advance for fresh fish and at least 72 hours in advance for frozen fish. Details of these ports will be made available on www.gov.uk.
In addition, and depending on the outcome of negotiations between the EU and UK on an agreement in the area of fisheries, the seafood sector in Ireland could be especially significantly impacted by Brexit. Ireland strongly supports the EU’s position on fisheries as set down in the negotiating mandate which calls for the existing reciprocal access conditions, quota shares and the traditional activity of the Union fleet be upheld in respect of fisheries. In line with the Political Declaration, agreed between the EU and the UK, and with the EU mandate, an FTA will only be concluded with an agreement on fisheries.
The Government recognises the importance of agriculture and fisheries, in supporting balanced regional and coastal development and employment. We will continue to work closely with the EU and fellow Member States to identify options for the fishing industry, including a common framework to manage potential tying-up of boats in a situation where no agreement is reached with the UK.
In accordance with the Protocol on Ireland/Northern Ireland, Northern Ireland will remain aligned to a limited set of Union rules, notably related to goods, and the Union Customs Code.
Northern Ireland must fully comply with relevant EU rules and standards, for example on food products and live animals to ensure adherence to SPS and IUU requirements.
- Work to achieve the best possible outcome for the agri-food sector from the EU-UK negotiations, in the form of continued tariff-free and quota-free access to the UK market, with minimal additional customs and administrative procedures, and minimisation of the risk from UK trade agreements with third
- Work closely with the EU Task Force and other Member States on fisheries to uphold existing reciprocal access conditions, quota shares and the traditional activity of the EU fleet, while ensuring that any fisheries issues are dealt with as part of an overall trade deal.
- Consider further supports and programmes needed to support the agri-food and fishing sector in light of Brexit, including as part of the preparation of Budget
- Have resources in place to address additional regulatory and certification requirements for Irish-UK
- Engage extensively with the sectors and stakeholders over the coming months, as part of the overall Brexit Communications campaign, to ensure industry is aware of the changes and preparations they need to make to be ready for 1 January
- Continue to engage constructively with the European Commission to explore the full range of State aid flexibilities and supports for sectors impacted by
- Work with the Commission to ensure Irish businesses and affected sectors benefit from the €5 billion Brexit Adjustment Reserve, to the maximum extent
- Work closely with the EU and fellow Member States to identify options for the fishing industry including a common framework to manage potential tying-up of boats, the possible risk of displacement of EU vessels into the Irish EEZ, and short-term and long- term funding for the sector, including through the Brexit Adjustment Reserve, to the maximum extent
Movement of Horses/Equines
EU law has provided a shared framework allowing Ireland, France and the UK to agree a specific arrangement for the movement of registered high-health equine animals; the so-called Tripartite Agreement (TPA). This agreement will lapse at the end of the transition period thereby removing the free movement of high-health horses between Ireland, UK and France. This will bring about significant change for the industry, as extra certification and controls will apply to movement of horses between Ireland and Great Britain.
A successor agreement to the TPA may be agreed in respect of North/South movement of horses if Northern Ireland continues to provide the necessary guarantees on maintaining high- health status, and if the UK can continue to guarantee all other controls are carried out – including on horses coming from Great Britain into Northern Ireland.
In order for movement of equine animals between the UK and the EU to continue after the transition period, the UK will need to be listed by the Commission as a third country eligible to export horses to the EU. After the transition period ends, equine animals entering Ireland from Great Britain may only enter Ireland via an EU Border Control Post (BCP) approved for that species. The BCPs approved for both registered and non-registered horses are Dublin and Shannon airports, Dublin Port and Rosslare Port.
Specific controls for movements from Great Britain to Ireland, including blood testing and residency requirements will also apply, depending on the sanitary group (health status category) the Commission assigns to the UK and the purpose and duration of the equine movement. This categorisation will only be confirmed closer to the date on which the transition period ends.
Equine animals moving to, and through UK, will be subject to UK Government requirements. Customs controls will also apply to equine movements between Ireland and Great Britain.
2.3.2. Non-commercial movement of pets
Non-commercial pet movements refer to dogs, cats and ferrets travelling accompanied by their owner. When the transition period ends the rules on non-commercial pet movements between Ireland and Great Britain will change. The nature of these changes are not yet confirmed and may not be decided until close to the end of the transition period. Depending on the final shape of these changes, there is a risk of significant disruption to those bringing pets from Great Britain to Ireland, including potential delays or quarantines of up to four months. Once requirements have been clarified, the Government will engage further with stakeholders to ensure they are aware of the changes.
The Protocol on Ireland and Northern Ireland ensures that pet movements between Ireland and Northern Ireland will continue on the same basis as they do today.
Information on the requirements for bringing a pet dog, cat or ferret from the UK to Ireland can be found on the website of the Department of Agriculture, Food and the Marine.
2.3.3. Supply of Veterinary Medicine Products (VMP)
Similar to the situation with human medicines the sale and supply of veterinary medicines is carefully regulated to ensure animal safety and welfare.
Post-transition, the UK will no longer participate in the EU system for the regulation of veterinary medicines, therefore it is possible that a limited number of veterinary medicines currently manufactured, quality controlled or batch released in the UK may no longer be made available for sale in Ireland for commercial reasons.
The Government and the Health Products Regulatory Authority (HPRA) have continued to engage with industry manufacturers, marketing authorisation holders, wholesale distributors, farming and veterinary stakeholders over the past two years to ensure a stable supply of veterinary medicines post-Brexit.
2.4. Retail Trade (including Online Retail)
The introduction of new import and export processes along with enhanced checks and controls on trade between the EU and UK may lead to disruption in the supply chains of Irish-based retail businesses. Substantial Brexit preparations were undertaken by these firms in 2019. Further work on understanding and strengthening supply chains also took place in response to the COVID-19 crisis. As substantial changes will take place for this sector regardless of the outcome of the EU-UK future partnership negotiations, it is important that these preparations are intensified to mitigate disruption to supply chains for essential goods due to lack of business readiness, and/or congestion at ports.
The Government will continue to work closely with the Retail Forum and with stakeholders in the grocery retail and distribution sector, to ensure that preparations are being undertaken by businesses to manage potential impacts on supply chains from the end of the transition period, so as to minimise risk of disruption.
While e-commerce flows may well continue after the end of the transition period, the operating environment for online retail will change, including for consumers buying from UK traders operating from/through websites in the UK.
Consumers should be aware that from 1 January 2021 purchases from or through websites in the UK will incur additional import charges, duty and VAT, just as for any other third country. Administrative costs of export and re-import declarations in relation to returns for retailers will arise. Products of animals or plants subject to SPS checks will have to undergo such checks and fees may be payable. In certain instances, EU consumer protection legislation may no longer apply to or in respect of the UK, removing the legally enforceable guarantees currently available in EU law to both retailers and consumers. The Competition and Consumer Protection Commission (CCPC) website has extensive information for consumers and businesses. It also sets out the changes to consumer rights for those purchasing from the UK including through shopping online. It also has information on extra taxes and charges consumers may need to pay when ordering online from a country outside the EU.
Supply of Medicines and Medical Devices
The Department of Health is working closely with the Health Service Executive (HSE), and the Health Products Regulatory Authority (HPRA), along with stakeholders throughout the supply chain, at national and EU level to ensure that regulatory issues and any potential supply issues arising from Brexit are addressed, in so far as is possible, to protect the continuity of supply of medicines and medical devices.
The Government will also continue to work with the European Commission and relevant stakeholders to ensure that patients in Ireland will continue to have access to high quality, safe and effective treatments.
As a result of measures undertaken at industry, national and EU level, Brexit is not expected to have any immediate impact on the supply of medicines. Any emerging supply issues, due to disruption at ports, for example, will, in the first instance, be dealt with from existing supplies held within the domestic supply chain. There are already additional stocks of medicines routinely built into the Irish medicine supply chain, which is different to the wholesaling model in the UK. Through collaborative engagement with medicines manufacturers and wholesalers, they have assured us that they are confident that they will have sufficient stocks to bridge any initial issues at ports, should they occur.
Medicine shortages do arise from time to time and the Irish health sector has an established national, multi-stakeholder, Medicine Shortages Framework in place to prevent and react to any potential medicine supply issues in Ireland. This multi-stakeholder mechanism will be used to address any potential medicine supply issues that may emerge.
Nonetheless, given the size of the Irish market, Brexit may cause those with a small share of a particular medicine market to consider the ongoing viability of supply to Ireland. However, as a result of the medicines criticality assessment exercises carried out in 2019, there is no evidence to suggest that any products that may be affected would be likely to be critical to continuity of care as there are, and will be, alternative suppliers or therapeutic alternatives available.
A further criticality assessment exercise will begin in October to refresh our assessment of the supply of medicines in the context of the ongoing COVID-19 pandemic. All available measures will be taken to ensure continuity of treatment for patients in Ireland.
Manufacturers with medical devices that are currently certified by UK notified bodies but placed on the EU market, need to transfer certificates to an EU27 notified body in advance of the end of the transition period. While one of the key issues regarding Brexit preparedness for medical devices previously was the relocation of UK notified bodies to the EU post-Brexit,significant progress has been achieved in this regard in recent months, with the final remaining UK notified body of key concern now accredited in Belgium, and it is understood that the transfer of certificates has progressed significantly.
A refresh of the criticality assessment exercises carried out in 2019 by the Department of Health, the HSE, and the HPRA to identify and assess any issues which may affect the supply of medical devices to Ireland after the end of the transition period, including regulatory issues, will be carried out in advance of the end of the transition period. As with the work on medicines, this refresh will also include an assessment of the impact of COVID-19 on the supply of medical devices.
|Businesses should now:
· Put in place necessary mitigation measures to ensure continuity of supply of medicines and medical devices. This should include reviewing stock levels and mapping supply routes to identify and resolve outstanding Brexit exposure issues.
· Complete remaining necessary regulatory changes to ensure that all medicines and medical devices on the Irish market meet EU regulatory requirements in advance of the end of the transition period including relocation of batch release and QC testing sites of medicines from the UK to EU/EEA and transfer of medical device certificates to EU27 notified bodies.