Office for Life Sciences Bulletin - 18th December 2020

Office for Life Sciences Bulletin – 18 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 – If you have any queries over the festive period, please contact euexit@officeforlifesciences.gov.uk.

NEW – ABHI are continuing to survey the HealthTech community to help them best understand the impact the pandemic has had on businesses. They are launching this survey for HealthTech suppliers, to capture data from the October/November 2020 period.

This survey will not be limited to ABHI members and will close at 5pm on Friday 8th January 2021.

NEW – All four of the UK’s Chief Medical Officers have announced that they are confident in reducing the number of days that contacts self-isolate from 14 days to 10 days after reviewing the evidence. Further information can be found here.

Transition Guidance NEW – MHRA have published guidance on the locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV) after the end of the Transition Period. Please find out more here.

NEW – MHRA have published guidance on what you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland from 1 January 2021.

Please find more information here.

UPDATED – MHRA have updated guidance on supplying authorised medicines to Northern Ireland from 1 January 2021. Please find more information here.

NEW – Your goods will be qualifying Northern Ireland goods from 1 January 2021, if they are in free circulation in Northern Ireland – that means, not under a customs procedure before you move them from Northern Ireland to Great Britain. For more information, click here.

NEW – The UK Trader Scheme has been launched to support business moving goods from Great Britain to Northern Ireland. For more information about what businesses need to do before their first movement of goods after 1 January 2021, click here.

NEW – Find out how to get authorised to declare goods you bring into Northern Ireland, not ‘at risk’ of moving to the EU, so that EU duty will not be payable on those goods. For more information, click here.

UPDATED – Guidance on how to prepare if you trade and move goods in and out of Northern Ireland from 1 January 2021, has been updated. For more information, click here.

UPDATED – Guidance has been updated to include links to new guidance on registering as a manufacturer to sell medical devices from 1 January 2021. For more information, click here.

NEW – For guidance on registering your medical devices with the Medicines and Healthcare products Regulatory Agency in GB and NI from 1 January 2021, click here.

UPDATED – For the current status of progress on trade agreements with non-EU countries, click here.

NEW – Guidance has been issued to explain how an importer can make a claim for preferential tariff treatment under the UK- Japan CEPA. For more information, click here.

NEW – The DIT Export Control Joint Unit will be making changes to SPIRE (the electronic strategic export licence database) in preparation for the end of the transition period. SPIRE will not be available on 31 December 2020. Read Notice to Exporters 2020/19 to find out more. See also some additional information you will need to supply when making applications, so that ECJU can issue the correct licence from 1 January 2021. Please also ensure you have registered for the Open General Export Licence (exports of dual-use items to EU member states) if you export dual-use items to the EU. From 1 January 2021, without this licence, your goods could be stopped by Customs.

NEW – Guidance on how to trade plants and plant products inside and outside the EU from 1 January 2021, has been updated to include a link to the PEACH user guide. For more information, click here.

UPDATED – The latest letters sent to VAT-registered busines in GB trading with the EU and/or the rest of the world, have been published, highlighting actions they need to take to continue trading with the EU from 1 January 2021. To view this in full, click here.

UPDATED – Guidance has been updated with information on getting access to your postponed import VAT statement has been added. For more information, click here.

NEW – Guidance has been issued that sets out how protection of trading interests (also known as the retained blocking regulation), will work in the UK from 1 January 2021. The Protection of Trading Interests Legislation protects UK persons trading with countries affected by the extraterritorial application of certain laws (currently US Sanctions against Iran and Cuba). For more information, click here.

NEW – If you're a haulier and move goods through a port in the UK that uses the Goods Vehicle Movement Service, you'll need to register for the service Goods Vehicle Movement Service to get your goods through customs. For more information and to register for the service, click here.

NEW – Guidance has been issued with information about how import VAT will apply to goods moving between GB and NI, for individuals and non-VAT registered businesses. For more information, click here.

UPDATED – Moving goods through the Port of Dover and Eurotunnel using common transit from 1 January 2021 guidance and information has been updated. For more information, click here.

UPDATED – Moving goods through the Port of Dover and Eurotunnel with an ATA Carnet from 1 January 2021 guidance has been updated, with details of inland border facilities, and transporting live animals under an ATA Carnet. For more information, click here.

UPDATED – Guidance about transporting live animals under an ATA Carnet through the Port of Holyhead has been updated. For more information, click here.

UPDATED – Guidance on what you need to do to prepare your business to move goods using common and Union Transit has been updated to explain what you need to do if you are using transit from 1 January 2021. For more information, click here.

UPDATED – The list of customs agents and fast parcel operators has been updated. Click here to view this.

UPDATED – Guidance has been updated to confirm that emails have been sent to tell applicants if they’ve been allocated an ECMT permit for 2021. For more information, click here.

UPDATED – Guidance on international trademarks and designs has been updated. For more information, click here.

UPDATED – Guidance on product safety and metrology has been updated for Great Britain and Northern Ireland. For more information on products placed on the GB market, click here.

For more information on products placed on the NI market click here.

UPDATED – Information has been updated for businesses about designated standards at the end of the Transition Period. Changes include Links to designated standards from 1 January 2021 added for PPE. For more information, click here.

UPDATED – Guidance has been updated to explain new processes for importing or moving animals and animal products into the GB from the EU, non-EU countries and NI. For more information, click here. For information on exporting live animals and animal products, please click here.

NEW – The ‘Check an HGV is ready to cross the border service’ can be used to apply for a Kent Access Permit, and to check if you have the paperwork you need to cross the UK border in an HGV. For more information and to use the service, click here.

NEW – Guidance has been issued on using the S&S GB Service if you import goods into Great Britain and need to make an entry summary declaration. For more information, click here.

NEW – Guidance to check the availability and any issues affecting the register to make an entry summary declaration in Great Britain service has been issued. For more information, click here.

NEW – To find out which locations are using the Goods Vehicle Movement Service from 1 January, click here.

UPDATED – Kent traffic management on the M20 motorway to Dover and Eurotunnel: Guidance has been updated to include information on driver welfare. For more information, click here.

UPDATED – Guidance on what UK lorry and goods vehicle drivers need to do to drive professionally in the EU from 1 January 2021, has been updated with information about the Check an HGV is ready to cross the border’ service. For more information, click here.

NEW – On 1 January 2021, there will be some changes to how the supplementary protection certificate (SPC) system operates. This guidance explains the changes, and what you need to do differently as a result. To view this, click here.

UPDATED – MHRA have updated guidance on submitting clinical trial safety reports from 1 January 2021. Please find more information 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.

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 – Chancellor Rishi Sunak announced on 17 December that the UK's furlough scheme will be extended for an extra month until the end of April 2021. Further information can be found here.

UPDATED – Information about holiday pay and unpaid sabbatical or unpaid leave has been updated. Click here.

Business Support NEW – Income Tax and National Insurance contributions exemption for employerreimbursed coronavirus antigen tests: This measure aims to ensure that there is no National Insurance contributions liability where an employer reimburses an employee for the cost of a relevant coronavirus antigen test. This measure will have effect from 25 January 2021 until 5 April 2021. For more on the detailed proposal click here.

NEW – HMG has suspended import tariffs on Covid-19 products to fight the virus. The new measures, which ensure no tariffs will be due on imports of goods including face masks, gloves, and other protective equipment, will come into effect from 1 January 2021. For more information, click 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