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The NPA has collated the Government’s Brexit guidance to inform and advise community pharmacists and their staff.
Latest news: The Brexit transition period has now ended. The UK government says it has agreed a trade deal with the European Union. The NPA will continue to inform and advise our members. Please continue to visit this page for further information and advice.
The NPA has been and continues to represent the interests of community pharmacy in discussions with the MHRA, Department of Health and Social Care (DHSC) and other relevant government bodies. Our key priority throughout the Brexit process has been minimising any disruption to medicines supplies, pricing, and the work of community pharmacy. To this end, we continue to collaborate with our counterparts from other national pharmacy organisations and medicine suppliers via the Community Pharmacy Brexit Forum.
Borders Bulletin
This bulletin provides the latest news from the Government relating to UK borders. It includes helpline numbers and details of webinars and videos. Click here to see the latest bulletin.
New “Energy Bills Discount Scheme” for businesses
A new energy scheme for businesses, charities, and the public sector has been confirmed ahead of the current scheme ending in March 2023. The new scheme will mean all eligible UK businesses and other non-domestic energy users will receive a discount on high energy bills until 31 March 2024. Read more here.
Medicines supply in Northern Ireland (22 December 2021)
Details of the outcome of negotiations between the EU and the UK government have confirmed that there will be no regulatory barriers to the supply of medicines from Great Britain to Northern Ireland. The UK-wide regulatory routes will apply.
More details and guidance are expected to be posted on the MHRA website.
If you are aware of any supply disruptions, please contact Helga Mangion at independentsvoice@npa.co.uk
Northern Ireland Protocol update (15 Dec 2021)
Following a ministerial statement today (15 December) by the Minister of State in the Cabinet Office, Lord Frost, it has been announced that the negotiations on the Northern Ireland Protocol are still under way and will not be definitively completed by 1 January 2022. Therefore, Ministers have decided to extend the current arrangements on a temporary basis in regards to the movement of goods of products from the Island of Ireland to GB.
Goods movement will continue on rules that currently apply until further notice. These arrangements are temporary and will be kept under review as negotiations on the Protocol continue.
| The Brexit transition period has now ended
There are changes to:
Check the new rules from January 2021 below and take action now; This page tells you what you’ll need to do to supply authorised medicines from Great Britain to Northern Ireland. NEW: Brexit FAQs – Read here Business support helplines To help businesses now that the Brexit transition period is over, helplines have been set up by the Government for each of the four home nations. England, call 0800 998 1098 Scotland, call 0300 303 0660 Wales, call 0300 060 3000 Northern Ireland, call 0800 181 4422. For more information, including opening hours, click here. Brexit transition helplines: A list of government helplines organised by theme and key actions for businesses has been published. To view this, click here. New Brexit Support Fund The SME Brexit Support Fund helps small businesses adjust to new customs procedures, rules of origin and VAT rules when trading with the EU. SMEs who trade only with the EU, and are therefore new to importing and exporting processes, can apply for grants of up to £2,000 to pay for practical support including training and professional advice to ensure they can continue trading effectively with the EU. For more information, click here. Full guidance on how you can use the grant, who can apply and how to apply, is here. HMRC’s Customs and International Trade Helpline You can call and speak to an advisor on 0300 322 9434. The helpline is open from 8am to 10pm, Monday to Friday, and from 8am to 4pm at weekends. Or you can send HMRC your questions or use their webchat service. NEW: Video explainers on doing business with Europe The Government has launched a series of on-demand videos to help businesses familiarise themselves with the new rules and the actions they should take. Businesses can find out more about 18 topics, including importing and exporting, trade, data, hiring, audit and accounting. Register to access the video content. Click here for updates on:
The link also has an update on the work of the Medicines Shortages Response Group and efforts to maintain continuity of supply of medicines. EORI numbers and the Trader Support Service For advice on EORI numbers (needed to move goods between the UK and non-EU countries) and moving goods between Great Britain and Northern Ireland, sign up to the Trader Support Service. It is free if you trade with Northern Ireland. Additional guidance for NI businesses is available here. |
We are sure many of our members have seen the news about the Windsor Framework. It would appear to address the concerns on medicines supply we shared with an inquiry by the House of Lords European Affairs Sub-Committee on the Northern Ireland Protocol. We will now want to examine the small print to ensure the new arrangements proposed will ease the difficulties in the supply of medicines and the bureaucratic burden of compliance with FMD
Batch testing review – message from DHSC
The Department of Health and Social Care’s review into the UK’s future approach to batch testing of medicines has concluded. You can read the formal government response and conclusion of the batch testing review, which includes detailed analysis of the public consultation.
After careful consideration of responses to the public consultation, alongside additional evidence gathered for the impact assessment, stakeholder engagement, and views of the Medicines and Healthcare Regulatory Agency, the government has decided to make permanent the approach favoured by the majority (72%) of respondents – no import testing or UK Qualified Person (QP) certification for medicines imported from countries on the list of approved countries for import.
As this policy is currently in operation and in legislation, there is no need for a two-year period to allow industry to prepare for implementation. The list of approved countries for import is in addition to, but separate from, the existing mutual recognition agreements (MRAs) the UK has with seven countries covering the batch testing of medicines. Guidance will also be issued to the sector on the long-term operation of the list of approved countries, including how the membership will be reviewed, in due course.
For further information, please direct your query to the batch testing policy team at medicines.goods@dhsc.gov.uk
Changes to French VAT regime
Some important changes will be coming into effect from 1 January 2022 in the French VAT regime which will affect companies exporting goods from the UK to France. From 1 January 2022, VAT on imports in France will no longer be collected by the customs authorities but will be automatically reverse-charged on the importer’s French VAT returns. This means it will not be possible to import goods into France without a France VAT number as all companies acting as importers of record in France will need to have a valid French VAT number and file VAT declarations. Foreign companies can register for VAT in France even if they are not established in France or elsewhere in the EU.
DIT France will be partnering with RM Boulanger, a company specialised in cross-border formalities and tax matters, for a webinar on these changes on 16 December at 3pm. You can find more information and register for the webinar here.
The MHRA has sent an open letter to the medical devices industry regarding importer obligations for Northern Ireland under Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Click here to read the letter.
Trading with the EU and Northern Ireland – SME toolkit: A new summary of actions SMEs may need to take to trade with the EU. You can find and share the document by navigating to ‘resources’.
Business travel explainer: A step-by-step guide to help prepare for business travel in the EU.
The NPA has been successful in petitioning the Migration Advisory Committee at the Home Office for pharmacists to be added to the Shortage Occupation List (SOL). This means that any pharmacist applying to enter the UK under the new scheme will automatically be awarded 20 of the 70 points needed under the new points-based immigration system. This system is not applicable to hiring Irish citizens, or EU citizens already living and working in the UK and are eligible under the EU settlement scheme. Click to find out more about the UK point-based immigration system: employer information.
Cyber Aware: The government’s advice on how to stay secure online. Businesses can use this link to access the Cyber Action Plan which provide a list of personalised actions businesses can take to help protect themselves.
The Border and Protocol Delivery Group Update is produced by the Cabinet Office and provides the latest news from the Government relating to UK borders following the end of the Brexit transition period. It includes a list of helplines and online forums and links to webinars and on-demand videos, as well as other items of news. It can be found here. There is also a Businesses Readiness Information document (week ending 5 November 2021) here.
Office for Life Sciences Bulletin
The Office for Life Sciences (OLS) is a joint unit between the Department of Health & Social Care (DHSC) and Department for Business, Energy & Industrial Strategy (BEIS). This bulletin aims to keep the life sciences sector up to date on the latest government guidance on workforce, trade, regulation and the Coronavirus (COVID-19) outbreak, providing you with information from Government to help your members and networks.
Click here to read the latest bulletin.
NEW: Rules of Origin for trading with the EU
Rules of Origin determine the economic nationality of a good under a Free Trade Agreement (FTA). Businesses need to know about them because the Trade and Cooperation Agreement (TCA) means they can trade with the EU without paying tariffs – but only if their product meets the relevant Rules of Origin.
Please click here for a short explainer on Rules of Origin. FAQs on Rules of Origin from the Department for Business, Energy and Industrial Strategy can be found here.
The UK Trader Scheme
If you move goods between Great Britain and Northern Ireland, you should apply to the UK Trader Scheme (UKTS) as soon as possible.
Following the end of the Brexit transition period, tariffs are only due on goods moving into NI from GB where they are destined for the EU, or where there is uncertainty or a genuine risk of onward movement. Traders moving goods into NI for the purposes of onward movement to the EU must always pay the EU tariff.
UKTS was launched to support businesses moving goods from GB to NI to help ensure traders do not pay tariffs on the movement of goods into NI from GB where those goods remain in the UK’s customs territory. Through UKTS, traders can self-declare goods not ‘at risk’ of entering the EU so that they are not subject to EU duty.
The scheme is open to traders of all sizes and across all industries who operate under the Northern Ireland Protocol (NIP). When applying to HMRC for UKTS authorisation, traders must meet some basic requirements and show that they are able to accurately declare and evidence whether goods are ‘at risk’ or not. There are provisions to support businesses with no fixed address in Northern Ireland to benefit from UKTS, while they make changes to be able to benefit in the long term.
Apply before the end of February 2021 and you will get a provisional authorisation for up to four months while HMRC processes your application. During this time, you may declare goods as not ‘at risk’.
Applications received after the end of February 2021 will be processed as normal. This can take up to a month, so you must ensure you apply one month before you plan to declare goods not ‘at risk’.
Click here, to register for UKTS.
NEW – MHRA guidance on the distance selling logo from 1st January 2021.
19th April 2021:
VAT: Trading and moving goods in and out of Northern Ireland: Information has been added to guidance with information about when to use an ‘XI’ prefix in UK VAT numbers in the ‘paying VAT’ section. For more information, click here.
Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs): A list has been produced by the MHRA of the products licence MA numbers for the grandfathering of CAP MAs. For more information, click here.
23rd December
Brexit transition: Frequently asked questions
The MHRA has produced some FAQs on the Brexit transition covering a variety of topics. Click here to read.
30th November Update:
Transition period: Letter to the professional and business services sector
Click here to read a letter from the Secretary of State for Business, Energy and Industrial Strategy, Alok Sharma, to the professional and business services sector about actions they need to take from 1 January 2021.
Workforce
Employer information about the UK points-based immigration system: Information for employers to help them prepare for the UK’s new point-based immigration system from 1 January 2021 has been updated. For more information, click here.
Trading
Trading with Japan: Guidance on trading with Japan has been updated with details of how trading with Japan will change from 1 January 2021. To view this, click here.
Data
Using personal data in your businesses or other organisations from 1 January 2021: Guidance has been updated on what action you need to take regarding data protection and data flows with the EU/EEA after the end of the transition period. For more information, click here.
Intellectual Property
Intellectual Property after 1 January 2021: Guidance for customers and users of Intellectual Property – about how the Intellectual Property system and the Intellectual Property Office will operate after the end of the transition period – has been updated. From 1 January 2021, subject to legislative implementation, only an address for service in the UK (which for these purposes includes the Isle of Man), Gibraltar or the Channel Islands will be accepted for new applications and new requests to start contentious proceedings before the IPO. The change will apply across all the registered IP rights (patents, trademarks and designs). For more information, click here.
25th November update:
Brexit transition webinars
With time running out until the end of the Brexit transition period on December 31, webinars are available from the Government to help prepare your business.
It has announced sector-specific webinars, which are available on demand here.
For the latest transition information, sign up to the Government’s Transition Readiness Business Bulletin here
Pay deferred VAT
Pay now or get ready to opt in to the VAT deferral new payment scheme. If you deferred VAT between 20 March and 30 June 2020, and still have payments to make, you can:
Check how you can pay your deferred VAT.
If you want to opt in to the new payment scheme: You cannot opt in yet. The online opt in process will be available in early 2021. You must opt in yourself; your agent cannot do this for you.
Instead of paying the full amount by the end of March 2021, you can make up to 11 smaller monthly instalments, interest free. All instalments must be paid by the end of March 2022. For more on the opt-in paying system, check here.
13th November 2020:
EORI numbers
From 1 January 2021, after the end of the Brexit transition period, all businesses will need an EORI number to move goods between Great Britain (England, Scotland and Wales) and the EU. You may also need one if you move goods to or from Northern Ireland.
Businesses without one are advised to apply for an EORI number as soon as possible. Not having an EORI may result in increased costs and delays. A post or parcel company can tell you if you need an EORI number.
More details on what to do before applying for a number and more information is here.
You can apply for an EORI number here.
Coronavirus Bounce Back Loan
Smaller businesses can access finance more quickly during COVID-19 with the Bounce Back Loan Scheme. New options are available to top up existing loans, extend the loan period, make interest-only repayments, or pause repayments.
The scheme is open to applications until 31 January 2021. If you already have a Bounce Back Loan but borrowed less than you were entitled to, you can top up your existing loan to your maximum amount. You must request the top-up by 31 January 2021. For more information about the scheme click here.
Claiming Statutory Sick Pay paid to employees due to Coronavirus
Find out if you can use the Coronavirus Statutory Sick Pay Rebate Scheme to claim back employees’ coronavirus-related Statutory Sick Pay (SSP). The online service to claim back SSP is now available. For more information on who can use the scheme, click here.
Intellectual Property Rules
At the end of the Brexit transition period there will be changes to how the Intellectual Property (IP) system and the Intellectual Property Office (IPO) will operate. These changes will affect areas including trade marks and designs and parallel trade from the UK to the EEA. You can find out more information about these changes from the Intellectual Property Office here. If you export IP-protected goods on the secondary or parallel market, contact the rights holder in the EEA to see if you have permission to continue to parallel export. Consider if you want exports to continue if you are a business that owns the IP rights for goods currently parallel exported from the UK to the EEA.
HMRC support during COVID-19
HMRC has issued a briefing on how they will work with businesses over the coming months while COVID-19 continues to impact the country.
To sign up for updates from the Department for Business, Energy and Industrial Strategy, click here.
The way you hire from the EU is changing
From 1 January 2021, the UK will introduce a points-based immigration system that will treat EU and non-EU citizens equally and transform the way in which employers recruit internationally. More details here.
It is vital that you prepare now for our new relationship with the EU, outside of the single market and customs union. There will be no extension to the transition period, so you need to act now, according to the government.
Together with other pharmacy bodies, the NPA has been successful in petitioning for pharmacists to be added to the Shortage Occupation List (SOL). This means that any pharmacist applying to enter the UK under the new scheme will automatically be awarded 20 points of the 70 points needed under the new points-based immigration system.
This system is not applicable to hiring Irish citizens, or EU citizens already living and working in the UK and are eligible under the EU settlement scheme.
UK Government: Letters to businesses about trade arrangements after the UK has left the EU.
NHS: information for patients about possible impact of a no-deal Brexit
NPA: FMD information and guidance
UK Government: EU Settlement Scheme
UK Government: no–deal preparations – community pharmacy and retail sectors
UK Government: recognition of professional qualifications if there’s a no-deal Brexit
| Latest update:Using CHIEF for declaring goods into or out of Northern Ireland
Using the Customs Handling of Import and Export Freight (CHIEF) for declaring goods into or out of Northern Ireland: Guidance has been updated with information about the use of CHIEF before making declarations. For more information, click here |
Northern Ireland Protocol and medicine supplies
Click here for a joint statement by the co-chairs of the EU-UK Joint Committee which includes the supply of medicines.
18th December 2020
Guidance for pharmacists on EEA prescriptions post 31st December 2020.
23rd November 2020
The Northern Ireland Protocol comes into force from 1st January 2021. For as long as it is in force, Northern Ireland will align with relevant EU rules relating to the placing on the market of manufactured goods.
The application of the Protocol will involve some changes for goods movements into Northern Ireland and the UK unfettered access policy will ensure that businesses and individuals will be able to move goods from Northern Ireland into the rest of the United Kingdom on the same basis as now. For the most up to date information, click here.
9th November – Latest press release: NPA welcomes phased implementation of Brexit medicines changes in Northern Ireland
A message from the Chief Medical Officer in regards to medicines supply and Brexit
Department of Health NI: Brexit readiness guidance
Latest CPO NI communication to HSC NI – Re: continuity supply of medicines and medical products in the UK
Latest update- 10.12.20: NHS England: As negotiations are still underway, the Chief Pharmaceutical Officer Keith Ridge provides an update on the continuity of medicines supply – please read here |
NHS England: How healthcare providers can prepare for Brexit
NHS England: Selling services to the EU, Switzerland, Norway, Iceland and Liechtenstein after Brexit
Scottish Government: Brexit information
Health and social care in Scotland after Brexit (medicines and services)
Highlands and Islands Enterprise / Business Gateway / Scottish Development International / Scottish Enterprise / Skills Development Scotland: Business Support
Citizens Advice Scotland: EU citizens with particular challenges can contact Citizens Advice Scotland on the full-time national helpline 0800 916 9847
Audit Scotland Paper: Preparing for withdrawal from the European Union
Scottish Government: Brexit Vulnerability Index Map
Scottish Government: EU citizens staying in Scotland
Scottish Government: Update on Medicines supplies
CPW: Brexit – the health landscape
UK Government: EU Settlement Scheme – Welsh materials
NHS Wales: Letter to Healthcare Professionals
Welsh Government: Health and Social Services