Office for Life Sciences Bulletin – 6 November 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
News NEW – Northern Ireland Protocol. The UK has issued a statement following the fourth meeting of the Ireland/Northern Ireland Specialised Committee between the UK Government and European Commission. The UK and EU have jointly agreed a phased approach to implementing medicines regulation in Northern Ireland up to 31 December 2021, providing the additional time needed for businesses to prepare in relation to batch testing, importation and Falsified Medicines Directive requirements. Please find the statement here. NEW – Click here to read the Business Secretary’s full speech at the CBI annual conference covering Covid measures and help for business.
Transition Guidance NEW – For more information about the 12-point checklist to understand what you need to do to prepare for the end of the transition period if you work in the life sciences sector before 1 January 2021, click here. NEW – Guidance on using the UKNI marking from 1 January 20201. The UKNI marking is a new conformity marking for products placed on the market in Northern Ireland which
have undergone mandatory third-party conformity assessment by a body based in the UK. To find out if you need to use it, and if so, how, click here. UPDATED – Guidance has been updated on applying for grants if your business completes customs declarations for funding for recruitment, training and IT improvements. Information has been added about General Block Exemption Regulations (GBER). Click here for more information. UPDATED – Updated guidance on the zero rate of VAT for the supply of PPE equipment reverting to the standard rate of VAT from 1 November 2020. UPDATED – ECMT international road haulage permits guidance now includes a direct link to the service to apply for ECMT permits for 2021. The deadline to apply is 11:59pm on 20 November 2020, please find further information here. UPDATED – There is added guidance on the documents you will need to transport live animals with regards to exporting or moving live animals and animal products to the EU from 1 January 2021 and importing animals, animal products and high-risk food and feed not of animal origin from 1 January 2021. REMINDER – From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator. Submissions related to human medicines will need to be submitted directly to the MHRA from this date.
The agency has put new systems in place to ensure that companies can continue to submit regulatory and notification information to the UK. Companies that have not registered to date are advised to register now, so that they are ready to make submissions from 1 January 2021.
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. Various dates – 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. Wednesday 11 November – Providing services in the EU: professional qualifications, audit and accounting, and legal services, register here. Thursday 12 November – Chemical regulation, register here
Tuesday 17 November – IPO webinar, covering changes to registration of EU Trade Marks and Designs, how parallel trade with the EU will change after 1 Jan 2021, changes to copyright licencing and operational changes to office processes for the registration of trade marks, designs and patents after the end of the transition period. 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.
Workforce
NEW - In light of the increased restrictions the UK government is introducing additional economic and business support measures: • • •
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The Coronavirus Job Retention Scheme has been extended to 31 March 2021. Please find more information here. The Job Support Scheme will not be introduced until after Coronavirus Job Retention Scheme ends. The Self-Employment Income Support Scheme grant is being extended and made available for 3-month periods covering November 2020 to January 2021 and February 2021 to April 2021. The grants will increase from 55% to 80% of average profits up to £7,500. Find out if you are eligible and how much you can get. Business premises forced to close in England due to local or national restrictions can find out more about Business Grants here. The application deadlines for the coronavirus Bounce Back Loan, Coronavirus Business Interruption Loan , Coronavirus Large Business Interruption Loan Scheme and coronavirus Future Fund have been extended until 31 January 2021.
Business Support NEW – The extended time limit for notifying an option to tax land and buildings applies to has been extended to decisions made between 15 February 2020 and 31 March 2021. For more information, click here.
Useful Links • •
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.
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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