Office for Life Sciences Bulletin – 11 December 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 nita.bhanot@beis.gov.uk
News NEW – Northern Ireland Protocol On 8 December the EU-UK Joint Committee published a statement on the implementation of the Withdrawal Agreement, please find it here. On 10 December the EU published a unilateral statement confirming that for 12 months from 1 January 2021 medicines can continue to be supplied to NI from GB as they are today. The EU statement sets out three elements to achieve this objective: • • •
Temporarily removing the obligation to decommission safety features when exporting to the UK. Allowing for quality control testing in Great Britain for a limited time. An abstention from sanctioning certain breaches of Union law arising due to the absence of manufacturing authorisation holders in Northern Ireland.
Please find the series of documents published here, and the declaration on medicines here.
Transition Guidance NEW – MHRA have published the guidance on how to register as a manufacturer to sell medical devices from 1 January 2021 for the markets in Great Britain and Northern Ireland. Please find more information here. NEW – Guidance has been issued covering what taxes and tariffs EU businesses might need to pay when trading with the UK from 1 January 2021. For more information, click here.
NEW – Guidance has been issued for EU businesses to find out what they need to do to export to the UK from 1 January 2021. For more information, click here. NEW – Guidance has been issued for EU businesses to inform them of what they need to do to import from the UK from 1 January 2021. For more information, click here. UPDATED – You can continue to sign up to TSS if you move goods between Great Britain and Northern Ireland. For more information, and to sign up, click here. UPDATED – Guidance for VAT registered business has been updated with information on Non-established taxable persons and guidance on how to complete your declaration if you are accounting for import VAT on your VAT return. For more information, click here. UPDATED – Guidance has been updated to include further detail about Operation Brock – the traffic management system designed to keep Kent’s roads open in the event of disruption at the Port of Dover and Eurotunnel. For more information, click here. NEW – Guidance has been issued for EU businesses to find out what they need to know about providing services in the UK from 1 January 2021. For more information, click here. UPDATED – Guidance has been updated for UK businesses on rules for trading in services with Ireland from 1 January 2021 to include information on the recognition of professional qualifications. For more information, click here. UPDATED – Guidance for UK businesses offering services to the EU, Switzerland, Norway, Iceland and Lichtenstein from 1 January 2021 has been updated with guidance for social security payments for employees. For more information, click here. NEW – Guidance has been issued for EU businesses to inform them of what they need to do with data protection, intellectual property and copyright in the UK from 1 January 2021. For more information, click here. UPDATED – Guidance for businesses and organisations holding EU trade marks at the end of the Transition Period has been updated to replace the section on pending cancellation actions. For more information, click here. UPDATED – The Business Secretary’s letter to the chemicals sector has been updated to reflect that chemicals regulatory obligations affect both new chemicals and existing chemicals already on the market. To view this in full, click here. NEW – Guidance has been issued on the UK Veterinary Medicines Regulations from 1 January 2021. For more information, click here. UPDATED – Guidance on pharmacovigilance procedures from 1 January 2021 has been updated to provide further information about country codes and worldwide case IDs which should be used when submitting and receiving ICSRs. For more information, click here. UPDATED – Guidance on converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021 has been updated. Guidance on ‘grandfathering’ and managing the lifecycle of medicinal products has been updated to include additional potential scenarios and clarify possible options available to applicants in relation to the processing and determination by the MHRA of pending Type IB and II variations at the time of the baseline submission. For more information, click here.
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. The Home Office has created a podcast episode in partnership with Intelligence Squared to help you prepare for the points-based immigration system. Listen now to Business and the Future of Immigration in 2021. Also available on Spotify and Apple 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 Completing customs import declaration, please register here. Various dates – DIT are hosting a webinar series for EU-based organisations that trade with the EU, covering GB-EU Border Formalities. Click here for more information and to register. 16 and 20 December - HSE and the Department for Environment, Food and Rural Affairs (DEFRA) will be hosting two webinars covering actions businesses need to take in preparation for the end UK Transition on 1 January 2021 when independent GB chemical regimes will be in place. To register, and for more information, click here.
Workforce
UPDATED – The Coronavirus Job Retention Scheme has been extended until the end of March 2021 for all parts of the UK. The full guidance for claims from November onwards, including how you can check if you’re eligible and how to calculate and make a claim online, can be found here. UPDATED – The Department for Education has announced a Level 3 qualifications offer and update on Skills Bootcamps. The Lifetime Skills Guarantee aims to transform the adult education system. From April 2021, adults without A Levels (or equivalent) will be eligible to study for a fullyfunded Level 3 qualification. Additionally, new Skills Bootcamps offer flexible courses of just 12-16 weeks, giving adults aged 19+, the opportunity to build sector-specific skills and fasttrack to an interview with a local employer.
Business Support NEW – In response to pressures on local and national supply chains, the Department for Transport has introduced a temporary and limited urgent relaxation of the enforcement of EU drivers’ hours rules in England, Scotland and Wales. This temporary relaxation will apply from 12:01am on 10 December 2020 and will run until 11:59pm on 30 December 2020.
Find out about who the relaxation applies to and information on using the relaxation here. NEW – Senior executives can temporarily leave quarantine in England if they are undertaking business activities which are likely to be of significant economic benefit to the UK. Find out who is exempted; how to comply with the exemption and examples of activity that would or would not likely to qualify for an exemption here. UPDATED – Working safely during Coronavirus guidance for labs and research facilities has been updated to clarify that workplace canteens open to staff only do not need to collect data for NHS Test and Trace. See the ‘What’s changed’ section for further information here. UPDATED – Guidance for businesses and organisations on how to recognise, contain and report incidents of coronavirus has been updated with a section ‘Early outbreak management action card example’. Check updated information contained within the “action card” here. UPDATED – Guidance on how to order PPE has been updated with order limits for domiciliary care providers. Eligible health and social care providers can order PPE through the portal to meet the increased need that has arisen as a result of the COVID-19 pandemic. The current order limits for different types and sizes of eligible health and social care providers can be found here. UPDATED – Guidance on medical devices given exceptional use authorisations during the COVID-19 pandemic has been updated 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
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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