Office for Life Sciences Bulletin - 23rd October 2020

Office for Life Sciences Bulletin – 23 October 2020

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 as we approach the end of the Transition Period 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 Sonia.Davies@officeforlifesciences.gov.uk HealthTech manufacturers survey ABHI have launched a survey to better understand and describe the impact of COVID-19 on the HealthTech sector, working closely with the Office for Life Sciences.

The survey is not limited to ABHI members and will close at 5pm on 30 October, at which point ABHI and OLS will work together to analyse the results and consider different solutions to support the sector.

If you would like to complete the survey, please find it here.

UK Transition: Stakeholder toolkit for business communications BEIS needs your help reaching businesses across the UK, encouraging them to take relevant actions before new rules come into force in January 2021. A new stakeholder toolkit of key messages and downloadable assets is now available for use across your social channels, newsletters, blogs and websites to help encourage businesses to you work with to take action. Find the toolkit here.

News NEW – New partnership agreements with four London university laboratories will increase testing capacity by tens of thousands over the winter period, as they become a part of the largest network of diagnostic testing facilities in British history.

NEW – Alok Sharma MP, Secretary of State for Business, Energy and Industrial Strategy, has written to businesses to highlight the major public information campaign to help firms prepare and keep businesses moving. It has one simple message: Time is running out, so you need to act now. Unless you take action, there is a risk your business operations will be interrupted: 1. Check what actions you need to take by visiting uk/transition.

2. Sign up for updates.

3. Attend government webinars for additional support, sign up here.

NEW – Government is developing an international regulatory cooperation strategy that’s looking at how the UK’s regulations, in comparison to different national and international regulatory requirements overseas, impact on the ability of UK businesses to trade and invest. To inform this work Government has launched an online call for evidence to hear from businesses about their priorities. The deadline for responses is 25 November 2020.

Contact ircconsultation@beis.gov.uk with any further questions or to become part of a network of regulatory cooperation practitioners.

Transition Guidance UPDATED – Guidance on supplying medicines to Northern Ireland from 1 January has been updated to include further information on checks needed and several case studies. Please find more information here.

UPDATED – Guidance on sourcing medicines for the Great Britain market from an approved country for import or Northern Ireland from 1 January 2021 has been updated, please see more information here.

UPDATED – Guidance on importing investigational medicinal products into Great Britain from approved countries from 1 January 2021 has been updated, please see more information here.

UPDATED – Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs has been updated, please find more information here.

UPDATED – Guidance on acting as a Responsible Person for import from 1 January 2021 has been updated, please find more information here.

UPDATED – The updated Border Operating Model provides further detail on how the GB-EU border will work and the actions that traders, hauliers and passengers need to take. These steps will be needed regardless of whether we reach a trade agreement with the EU. NEW – The government has announced a series of measures to help keep trade flowing by minimising the risk of disruption at the end of the transition period.

NEW – Check now whether your business will need to register for the Open General Export Licence (OGEL), for export of dual-use items to EU member states from 1 January 2021. A full listing of sectors covered, and how to register for the licence with the Export Control Joint Unit is contained in this Notice to Exporters.

NEW – HMRC has written to VAT-registered businesses highlighting actions they need to take to prepare for new processes for moving goods between Great Britain and the EU from 1 January 2021.

NEW – At the end of the transition period, the eCommerce Directive will no longer apply to the UK. You should begin to prepare for these changes now. Find out more here.

NEW – Using personal data in your business or other organisation after the transition period: What action you need to take regarding data protection and data flows with the EU/EEA after the end of the transition period.

NEW – Guidance on what you need to do before the end of the transition period if you hold a .eu domain, please find more information here.

NEW – Guidance on what you must do to comply with the regulations covering the security of network and information systems has been published.

NEW – Guidance on what organisations based outside of the UK offering services in the UK must do to comply with the regulations covering the security of network and information systems has been published.

NEW – Guidance on how trading in drug precursor chemicals will be affected from 2021 has been published.

UPDATED – Information for traders on importing and exporting goods between Great Britain and the EU after 1 January 2021 has been updated to remove references to Intrastat declarations for exports. You do not have to submit Intrastat declarations for goods exported from Great Britain to the EU. UPDATED – Guidance has been updated to reflect changes to the export process for live animals, products of animal origin and animal by-products from 1 January 2021.

UPDATED – HMRC has updated its list of customs agents and fast parcel operators who can help submit customs declarations.

Events Government departments are hosting a series of free webinars to help businesses understand the support available. Keep up to date with all the latest available webinars here, watch past HMRC videos here and find videos to help you learn more about trading with the EU from 1 January here.

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.

Tuesday 27 October – Life Sciences Business Support Webinar: The UK has left the EU and is leaving the EU single market and customs union. The end of the transition period means businesses should take action now to prepare for guaranteed changes and new rules from January 2021. To support business preparations the Department for Business, Energy

and Industrial Strategy is hosting free webinars to help you check the new rules and understand the actions to take. Please find the full schedule and sign up for live sessions here.

Wednesday 28 October – Changes to Intellectual Property webinar, please register here.

Monday 2 November – Chemicals Businesses webinar, please register here Friday 6 November - ABHI Procurement Conference: As the NHS gets back on its feet, and seeks to learn from the pandemic, what has this crisis meant for the future of NHS procurement? In this virtual ABHI conference you will hear from a host of leaders from across the procurement landscape to reflect on how the NHS will purchase in the future.

Please find more information and register here.

Wednesday 25 November – ABHI Regulatory Conference: Split into two parts, the morning session will focus on regulatory strategy, the shift towards global harmonisation and how, post-Brexit, regulation can contribute to the attractiveness of the UK as a place to develop and distribute health technologies. The afternoon session will address the practical elements of the UKCA mark, how this route will interact with Europe, and the actions companies need to undertake to ensure compliance. Please find more information and register here.

Friday 4 December – ABHI International Conference: In this ABHI International Conference delegates will hear about the support on offer to SMEs, as well as insights to help inform regulatory strategies and continuity of supply once the Transition Period ends. Please find more information and register here.

MHRA webinars From 1 January 2021, the MHRA will be the UK’s standalone medicines and medical devices regulator. Stakeholders need to get ready for new rules from 1 January 2021. The agency has now published guidance which will apply following the end of the transition period.

To help stakeholders understand the detail of the guidance and to ask any questions, the agency is running a series of free webinars, please click here for more detail on the webinar dates and topics.

Register for free webinars to learn more about what you need to do to export animals, fish and high risk foods not of animal origin from 1 January 2021.

Workforce

NEW – Further information for employers on employing EU, EEA and Swiss citizens in the UK, covering right to work checks, the EU Settlement Scheme and the UK’s new immigration system can be found here.

NEW – Information to help further education and training providers and employers of apprentices prepare for the end of the transition period on 31 December 2020.

Business Support UPDATED – MHRA guidance on the different types of tests and testing kits for COVID-19, and the specifications for manufacturers has been updated to include a Target Product Profile for Laboratory-Based SARS-CoV-2 Viral Detection Tests. Please find more information here.

UPDATED – The list of medical devices given exceptional use authorisations during the COVID-19 pandemic has been updated, please find more information here.

Useful Links • • • • • • • •

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Gov.uk/transition provides a central hub of resources for the transition period You can sign up to email alerts about the transition period on GOV.UK at this link.

Sign up for Home Office email updates about developments on the status of EU citizens in the UK after we leave the EU and 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.

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