Office for Life Sciences Bulletin – 26th March 2021

Office for Life Sciences Bulletin – 26 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 Government has published an ambitious vision for the future of clinical research delivery. Saving and improving lives: the future of UK clinical research delivery sets out to create more efficient research delivery, more diverse and accessible research, and to embed research in the NHS. Launch of the UK-wide vision will be followed by implementation plans and strategies setting out how the UK government and devolved administrations will work to deliver the vision during 2021 to 2022. For more information, click here.

NEW – The MHRA are running a pilot asking for evidence of patient involvement in drug development for clinical trials and marketing authorisation (new active substance or new indication) applications. The pilot will run until they have sufficient information from a variety of application types. For more information, click here.

UPDATED – Guidance has been updated to include a summary of changes to the lockdown rules in England from 29 March. For more information, click here.

Regulation

NEW – Guidance has been published for the veterinary pharmaceutical industry on how to apply for and maintain a joint-label for use on veterinary medicines placed on the market in the UK and Ireland. For more information, click here.

UPDATED – The MHRA have updated the guidance on how and when on-site inspections will resume at the end of March for the MHRA UK risk-based GxP inspection programme.

For more information, click here.

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

UPDATED – The MHRA have added information to the 'For industry and manufacturers: COVID-19 tests and testing kits' document. This now provides a link to Department of Health and Social Care’s information on the national standardised test performance process for manufacturers of SARS-CoV-2 virus antibody tests. For more information, click here.

Transition Guidance NEW – A new resource has been produced covering things that you need to consider when appointing a customs intermediary. To view this, and other useful resources, click here.

UPDATED – Guidance has been updated with information about what to do from 5 April 2021 when moving goods using transit in Northern Ireland. For more information, click here.

UPDATED – The final date that you can use the deferred declaration scheme, including submitting supplementary declarations up to 175 days after the goods have been imported, has been changed from 30 June 2021 to 31 December 2021. The date when you will need to submit safety and security declarations for imports into Great Britain from some countries has also changed from 1 July 2021 to 1 January 2022. For more information, click here.

UPDATED – Guidance on the rules of origin for goods moving between the UK and EU has been amended to reflect the new final date that traders can use the deferred declaration scheme. For more information, click here.

UPDATED – Guidance on moving goods through the Port of Holyhead has been updated with new information on the Holyhead Interim Inland Border Facility Service (used when moving goods with an ATA Carnet, Office of Departure or Office of Destination). For more information, click here.

UPDATED – Guidance on declaring reusable packaging for GB imports and exports has been updated to include the email address that quarterly reports on packaging need to be sent to. For more information, click here.

UPDATED – The list of customs agents and fast parcel operators who can help submit customs declarations, has been updated. For more information, click here.

UPDATED – Guidance has been updated for declaring goods not ‘at risk’ in the Customs Declaration Service and making a customs declaration in CHIEF for goods entering Northern Ireland from outside the UK and EU. For more information, click here.

UPDATED – Information has been added on how to make a declaration for your goods in CHIEF into and out of NI, and how to apply for authorisation to declare goods not ‘at risk’.

For more information, click here.

UPDATED – Guidance has been updated for what to do if you don’t meet the eligibility criteria to register and renew a .eu domain name in the UK. For more information, click here.

NEW – HMRC have set up a new haulier coordination team. For further information, sign up to receive updates via the regular Trader Support Service bulletin here. The latest bulletin

includes updates on making duty payments, the TSS API facility and Customs Declaration Service (CDS) maintenance on 1 April.

NEW – Cabinet Office have published an explainer for traders working to move goods to, from and through Northern Ireland. For more information, click here.

Business Support

NEW – The Restart Grant scheme supports businesses in the non-essential retail, hospitality, leisure, personal care, and accommodation sectors with a one-off grant to reopen safely as COVID-19 restrictions are lifted. Grants available from 1 April 2021 but applications can be submitted in advance. For more information, click here.

UPDATED – Guidance that sets out restrictions on certain businesses and venues in England during National Lockdown has been updated. For more information, click here.

NEW – HMRC has released a brief outlining an accelerated process for VAT registered businesses to request temporary alterations to their partial exemption methods to reflect changes to their business practices because of the coronavirus pandemic. For more information on the brief, click here.

UPDATED – Guidance on the Test and Trace Support Payment scheme has been updated to reflect that you can claim up to 42 days after the first day of your self-isolation period, and that the Test and Trace Support Payment scheme has been extended to parents and guardians who need to take time off work to care for a child who is self-isolating. For more information, click here.

Workforce UPDATED – Guidance on taxable expenses and benefits provided to employees during coronavirus has been updated to reflect information about paying or refunding transport costs for employees. For more information, click here.

UPDATED – Guidance on working safely during Coronavirus has been updated with a new shorter format focusing on actions to make your workplace COVID-secure. Step 1 of the roadmap out of lockdown has also been updated. For more information, click here.

UPDATED – Clinically extremely vulnerable people in England are no longer advised to shield from Thursday 1 April 2021. For more information, click here.

Events Keep up to date with all the latest available webinars: • • • •

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.

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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.

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.

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.

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.

30 March, 13:00 – An introduction to the NCSC’s Cyber Security Toolkit for Boards and key questions for board members to ask about cyber security. To register, click here.

NEW 30 March, 13:45 – HMRC webinar on the three stages of the new border controls introduced on 1 January 2021 and what actions you need to take for each stage. Register here.

NEW 31 March, 11:45 – HMRC webinar explaining actions you need to take to export goods from Great Britain to the EU and move goods between Great Britain and Northern Ireland.

Register here.

NEW 8 April, 11:45 – HMRC webinar explaining your responsibilities as a trader if you choose to use an intermediary from 1 January 2021. Register here.

Useful Links • • • • •

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.

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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 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