Office for Life Sciences Bulletin – 5th March 2021

Office for Life Sciences Bulletin – 5 March 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 Chancellor of the Exchequer, the Rt Hon Rishi Sunak MP, presented his Budget to Parliament on Wednesday 3 March 2021. For more information on the measures announced, click here.

NEW – The Secretary of State Grant Shapps chaired the first meeting of the new Global Travel Taskforce on 2 March 2021 to set out a plan for restarting international travel in a safe and sustainable way. The taskforce will provide a report to the Prime Minister on 12 April, which will be used to help determine when and how to resume safe international travel no earlier than 17 May 2021. For more information, click here.

Regulation

UPDATED – Guidance on how to apply for marketing authorisations via the new European Commission Decision Reliance Procedure (ECDRP) has been updated. For more information, click here.

UPDATED – Guidance has been updated on the Unfettered Access Procedure for marketing authorisations approved in Northern Ireland. New information has been added around how to get a 5-digit company number and there are new links to conditions for eligibility of unfettered access, and definitions of qualifying Northern Ireland goods. For more information, click here.

NEW – Authorised COVID-19 vaccines that are modified in response to new variants will not need a brand new approval or “lengthy” clinical studies, according to new guidance from the ACCESS Consortium. The guidance, developed by the MHRA and its ACCESS partners, lays out what information the medicines regulators would need to approve any modifications to authorised COVID-19 vaccines, should virus mutations make them less effective at preventing the disease. For more information, click here.

NEW – As part of an ongoing consultation that will help inform the MHRA’s strategy over the future use of regulatory flexibilities, the agency would like to gather further insight and options from a variety of healthcare professionals through a survey which will close at 5pm on Monday, 15 March 2021.

UPDATED – The MHRA have updated guidance on how tests and testing kits for COVID-19 work. They have published the Target Product Profile for rapid breath tests for the direct and indirect detection of SARS-CoV-2 specification for COVID-19 diagnostics. The guidance can be found here.

UPDATED - The MHRA have updated guidance on the different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment) with references to CE, CE UK Northern Ireland (UKNI) and UK Conformity Assessed (UKCA) markings in line with the end of the Brexit transition period.

UPDATED – The MHRA have updated the list of medical devices given exceptional use authorisations during the COVID-19 pandemic and the list of devices no longer covered. For more information, click here.

Transition Guidance NEW – The Department for Business, Energy and Industrial Strategy have published a toolkit aimed at small and medium sized businesses to help identify the decisions and actions they need to make to continue trading with the EU and the EFTA. To access this guidance, click here.

UPDATED – New documents about the Trade and Cooperation Agreement between the United Kingdom of Great Britain and Northern Ireland and the European Union have been made available. To view these, click here.

UPDATED – Guidance on transporting goods to the EU from the UK through roll on roll off ports or the Channel Tunnel has been updated with a new section on Assumed Departure.

For more information, click here.

UPDATED – Guidance for EU businesses has been updated with new information on: wood packaging material, importing animals, bringing food into the EU and transporting goods. For more information on importing to the UK click here, and for more information on exporting to the UK, click here.

UPDATED – Guidance about taxes and tariffs for EU businesses trading with the UK has been updated with new information about paying VAT or claiming VAT refunds. For more information, click here.

NEW – Guidance has been issued with information about changes for businesses and holders of international EU protected designs. For more information, click here.

Business Support

NEW – The Field Force Support Programme is offered by the Cabinet Office to support businesses that trade over £250,000 of goods with the EU each year. The Cabinet Office would like to support you and hear your views about the guidance you need. To be part of this programme, we would like you to answer a few questions about your business and the goods that you trade in. For more information and to fill in the contact form, click here.

NEW – The National Cyber Security Centre have launched a self-assessment tool to help sole traders and micro businesses check how safe they are from cyber threats, and to give advice on areas of improvement. To use the toolkit and for more information visit CyberAware.gov.uk.

UPDATED – The Coronavirus Job Retention Scheme has been extended until 30 September 2021. From 1 July 2021, the level of grant will be reduced each month and employers will be asked to contribute towards the cost of furloughed employees’ wages.

Guidance has been updated with information about how employees can use their personal tax account to see if they were included in any December 2020 claims. For more information, click here.

UPDATED – Guidance has been updated on the Kickstart Scheme Grant with information about what employers should spend the £1,500 funding for setup costs on and with information about what to do if a young person leaves their job placement early.

UPDATED – Guidance has been updated on Self Assessment payments to show you can set up a Time to Pay arrangement online for amounts up to £30,000 up to 60 days after 31 January 2021 without having to contact HMRC. UPDATED – Following a temporary pause, Companies House will resume strike off processes from 8 March 2021.

Workforce

UPDATED - Guidance for EU citizens on what they need to do if they are working in the UK has been updated with new business activity information, now including covid entry restrictions. For more information, click here.

NEW - A short explainer document has been produced to help you understand the new rules that are in place for business travel to Europe for work. These rules apply to you if you are travelling for work in Europe regardless of whether you are attending a conference or providing services. For more information on entry requirements, luggage, earnings, qualifications, and insurance pertaining to your travel, view the full explainer document.

NEW - This letter from the Business Secretary Kwasi Kwarteng encourages businesses to test their staff for COVID-19 by registering for free testing kits provided by the government.

These tests are for staff who cannot currently work from home. Only businesses registered in England can register for free testing.

UPDATED – Guidance for employers and third-party healthcare providers on the regulations and legal obligations of running testing programmes has been updated to reflect the ongoing evolution of private-sector testing.

NEW – A list of essential workers prioritised for PCR testing for coronavirus is available here.

NEW – New guidance details the steps to reopen certain businesses and venues in England.

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.

The Home Office has created a podcast episode to help you prepare for the pointsbased immigration system. Listen now to Business and the Future of Immigration in 2021. Also available on Spotify and Apple.

The Health and Safety Executive (HSE) is hosting a series of free podcasts to help businesses that make, use or supply chemicals, understand what actions they need to take. To listen to the podcast, just search ‘The HSE Podcast’ on your chosen platform. Audiences can also register to receive notifications for each episode released using this link.

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.

The Border and Protocol Delivery Group have produced a video series on border readiness at the end of the transition period on Short Straits and Landbridge and Direct Maritime Routes.

To view a webinar and Q&A session on the issues arising from goods moving from GB to the EU, via the short straits please click here.

NEW - A recording of the technical webinar on moving goods between GB and France hosted on 12 February 2021 is now available to view here.

Various dates - DHSC are holding open sessions on various topics in relation to the Goldacre Review, which are advertised on Eventbrite. Register your interest below: • Data Ethicists: 10/03/2021, 10-11:30 am • Professional Bodies: 10/03/2021, 12-1:30pm • Operational Researchers: 10/03/2021, 2-3:30pm • SMEs: 15/03/2021, 10-11:30am • Medical Research Charities: 17/03/2021, 3:30-5pm Various dates – Coronavirus (COVID-19) – Self-Employment Income Support Scheme (SEISS) Various dates – Extension to the Coronavirus Job Retention Scheme and flexible furloughing webinar. Register here.

Various dates – HMRC webinar on completing customs import declarations. To register and find a date, please click here.

Various dates – The National Cyber Security Centre is running a series of free cyber security webinars and talks aimed at UK businesses of all sizes, educational institutions and charities. For more information, click here.

NEW – 10 March (1:45-2:45), HMRC webinar on customs import declarations. To register, click here.

NEW – 12 March (11:45-12:45), HMRC webinar on trader responsibilities when using an intermediary. To register, click here.

NEW – The Secretary of State for the Department for Business, Energy and Industrial Strategy, Rt Hon Kwasi Kwarteng MP, is hosting the first in a series of live panel discussions with businesses next week on Green Jobs. Businesses can sign up 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.

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.

VAT guidance about the conditions for zero rating VAT on the goods you export, and what you should do when you export goods in specific circumstances.

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

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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