Office for Life Sciences Bulletin – 02 July 2021
OLS Introduction 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 guidance and during the Coronavirus (COVID-19) outbreak, providing you with information from Government to help your members and networks prepare. If you would like to be added to the distribution list, please email nita.bhanot@beis.gov.uk For any questions on the UK/EU Trade and Cooperation Agreement, please contact euexit@officeforlifesciences.gov.uk
News NEW – The European Union has formally recognised the UK’s high data protection standards after more than a year of constructive talks. This will allow the continued seamless flow of personal data from the EU to the UK. For more information, click here. NEW – The UK and Singapore have launched negotiations on a new ambitious digital trade agreement that could remove barriers to digital trade and enable UK exporters to expand into high-tech markets. For more information, click here. NEW – A new subsidy control system has been announced to provide quicker and more flexible support to UK businesses following our departure from the EU. For more information, click here.
Regulation UPDATED – An amendment to the Medical Devices Regulations 2021 has been published. For more information, click here.
Transition Guidance UPDATED – Guidance on using personal data in your business or other organisation has been updated to reflect that the EU has now formally adopted ‘adequacy decisions’ for the UK. For more information, click here. UPDATED – Guidance on moving your goods to common or EU transit countries has been updated with new information on movements starting in Great Britain and movements starting in Northern Ireland. For more information, click here. UPDATED – Guidance on moving goods into and out of Northern Ireland has been updated with information about the One Stop Shop (OSS) Union scheme and the VAT Import One Stop Shop (IOSS) scheme. For more information, click here. UPDATED – Guidance on delaying declarations for EU goods brought into Great Britain has been updated to tell you when to get an EORI number, when you (or the person acting on your behalf) can apply for an account to defer duty payments, what to do if you’re VAT registered (whether you or another person completes your declarations) and how to adjust your estimated import VAT when completing your next VAT Return if you do declarations yourself. For more information, click here. UPDATED – Guidance on applying for quota to import or produce ozone-depleting substances has been updated to show that registering for GB ODS quota 2022 is now live. For more information, click here. UPDATED – Guidance on EU business: data protection and copyright has been updated to reflect that the EU has now formally adopted ‘adequacy decisions’ for the UK. For more information, click here. NEW – Guidance on making a delayed supplementary import declaration using the Customs Declaration Service has been published. For more information, click here. NEW – Guidance for businesses on Brexit has been published covering importing and exporting, travelling to the EU, providing services to the EU, transporting goods to the EU, and exchanging data with EU businesses. For more information, click here. NEW – Guidance on using a fast parcel operator to import and export has been published. For more information, click here. UPDATED – The list of customs agents and the list of fast parcel operators has been updated. For more information, click here. UPDATED – Guidance on making a delayed supplementary import declaration using CHIEF has been updated on additional declaration type and description of goods. For more information, click here. UPDATED – Guidance on driving in the EU has been updated for UK driving licence holders living in France and Spain. For more information, click here.
Workforce UPDATED – Guidance on the new immigration system has been updated to remove guidance for EU, EEA and Swiss citizens visiting the UK to get married or form a civil partnership that expired on 30 June 2021, and remove guidance on right to work checks that expired on 30 June 2021. For more information, click here. UPDATED – Guidance on the EU Settlement Scheme: applying from outside the UK has been updated to reflect changes in relation to the end of the Grace Period. For more information, click here. UPDATED – Guidance on living in Europe before 1 January 2021 has been updated for UK nationals living in the EU and EEA EFTA countries before 1 January 2021. For more information, click here. UPDATED – Guidance on benefits and pensions for EEA and Swiss citizens in the UK has been updated to remove the reference to the deadline of 30 June 2021 to apply for settled or pre-settled status under the EU Settlement Scheme. Advice has been added to make a late application to the scheme as soon as possible. For more information, click here. UPDATED – Guidance on benefits and pensions for UK nationals in the EU, EEA or Switzerland has been updated with clarification that we will only ask for information when you claim a UK benefit from the EU, EEA or Switzerland if UK is the country you may be able to claim benefits from. A new link to more information on the benefits available to Ireland has also been added. For more information, click here. UPDATED – The register of written confirmations for UK active substance manufacturers has been updated under guidance on exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland. For more information, click here.
Events Keep up to date with all the latest available webinars: • • • • •
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Find videos to support your business during coronavirus disruptions here. Watch past HMRC videos on coronavirus here and UK transition here. Find videos to help you learn more about trading with the EU from 1 January here. Click here to view a list of webinars for organisations that trade with the EU you can watch live or on demand. BEIS has launched a series of on demand videos, to help businesses familiarise themselves with the new rules. Topics include importing and exporting, trade, Rules of Origin, tariffs, data, and audit and accounting. To view the videos, click here. Webinars giving an overview of the new rules that have come into place since leaving the EU customs union and the EU single market are now available to view. To access these, click here. New short videos have been produced to help explain importing and exporting of animal and plant goods. For more information, click here.
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Cabinet Office have published new recordings and videos that outline in more technical detail the new rules for moving goods to and from the EU. For more information, click here.
5-9 July 2021 – PAGB are hosting Digital Week, an online interactive conference taking place between 5 – 9 July. It will explore the key digital themes impacting consumer healthcare, including eCommerce, Real World Data/Evidence, advertising and social media, apps and medical devices, and self-care. For more information and to register, click here. 8 July 2021, 10-11:30 – Medtech Canada are hosting a webinar on the regulatory and innovation landscape in Canada. Click here to register. Various dates – A calendar of upcoming webinars for organisations that trade with the EU is available here. Topics include: importing, trader responsibilities, exporting and more. Upcoming HMRC Brexit webinars: • • • •
Various dates – Completing customs declarations: an overview. Register here. Various dates – Trader responsibilities when using an intermediary. Register here. Various dates – Importing: preparing to make your supplementary declaration. Register here. Various dates – Exporting: what you need to do to keep your goods moving. Register here.
Upcoming HMRC COVID-19 webinars: •
Various dates – Coronavirus Job Retention Scheme. Register here.
Useful Links • • • • • • • •
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Gov.uk/transition provides a central hub of resources You can sign up to email alerts on GOV.UK at this link. Sign up for Home Office email updates about the next steps for EU citizens in the UK at this link. Access the ‘Check How to Export Goods’ tool here for the information you need to export goods out of the UK market. Click here for more information and advice on exporting. Click here for updated information on the Covid-19 response from the Department for Health and Social Care and Public Health England. Click here for a list of Business Representative Organisations and Trade Associations you can speak with to get advice. Specific information for businesses and employers in Northern Ireland, Scotland, and Wales is available. In England, Growth Hubs can advise on local and UK Government business support. Register for HMRC’s free Trader Support Service if you are moving goods between Great Britain and Northern Ireland. Click here to view the latest weekly TSS bulletin.
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The most up-to-date guidance on the Northern Ireland Protocol is on GOV.UK, including information on moving goods into, out of, or through Northern Ireland. For general queries on transition issues, you can submit questions on BPDG’s online forum. BPDG will endeavour to provide answers to you as soon as possible. A list of government Brexit transition helplines organised by theme and key actions for businesses has been published. To view this, click here. COVID 19 key contact details: o General offers of help from industry: gcfcovid19enquiries@cabinetoffice.gov.uk, or visit this webpage. o Share the impact COVID-19 is having on your organisation with intel@beis.gov.uk o To provide feedback on MHRA engagement please contact engagement@mhra.gov.uk o To call the Business Support Helpline in England please dial FREEPHONE 0800 998 1098, Scotland 0300 303 0660, Business Wales 0330 060 300 and Invest Northern Ireland 0800 181 4422