Office for Life Sciences Bulletin - 8th January 2020

Office for Life Sciences Bulletin – 8 January 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 UK agreed a Trade and Cooperation Agreement with the EU on 24 December 2020. The text of the deal can be found here and a summary explainer can be found here.

NEW – After 31 December 2020, EU trade agreements will not apply to the UK. The UK has signed trade agreements with various countries and trading blocs.

For more information on signed trade agreements and trade agreements still in discussion, click here.

NEW – Please find a letter from Edward Argar MP, Minister of State at the Department of Health and Social Care, to the health and social care sector about the UK–EU Trade and Co-operation Agreement and the government's preparations for 1 January 2021 here.

Transition Guidance NEW – With a trade deal in place, UK businesses can trade tariff-free with the EU from 1 January if their products meet agreed Rules of Origin. UK traders need to check if their products comply and how to prove they originate. For more information, click here.

NEW – Guidance has been issued about approved exporter authorisations which are issued in the UK no longer being valid in EU countries from 1 January 2021. For more information, click here.

NEW – From 1 January 2021, reusable packaging will require an import or export declaration.

You may be able to make a declaration at the border (known as a ‘declaration by conduct’) instead and provide information to HMRC on a quarterly basis. For more information, click here.

UPDATED – Guidance on how sellers will deal with VAT for goods from overseas that they sell to customers in the UK from 1 January 2021 has been updated to include information about selling goods to Northern Ireland. For more information about selling goods directly to customers click here. For more information about selling goods in the UK using online marketplaces, click here.

UPDATED – From 1 January 2021, if you are a UK-based business sending goods from Great Britain or Northern Ireland or if you’re a UK-based business bringing or receiving goods into Great Britain or Northern Ireland check what declarations may need to be made. For more information about goods you send, click here.

UPDATED – Guidance has been updated with information added about accounting for VAT if you do not know the full customs value of goods and using someone to import goods on your behalf. For more information, click here.

UPDATED – Guidance has been updated to include information about the journeys you can make in the EU, including cross-trade and cabotage jobs, what you'll need ECMT permits for, and vehicle insurance green cards. For more information, click here.

NEW – Guidance has been added explaining how to claim preferential rates of duty on goods covered in the UK's deal with the EU and how to declare goods imported into the UK on your import declaration. For more information, click here.

UPDATED – If you are a haulier that moves goods through one or more ports that uses the Goods Vehicle Movement Service, you should apply to use Goods Vehicle Movement Service.

To register for the Goods Vehicle Movement Service click here. To get a goods movement reference using the service, click here. To check that a goods movement reference is valid and if goods can be moved, click here.

UPDATED – Guidance has been updated to explain why you need ECMT permits in 2021, and how to buy short-term (30-day) permits to use in January and February 2021 if you want to make a third cross-trade movement. For more information, click here.

NEW – Guidance has been issued so that you can find out how to claim a waiver if you are bringing goods into Northern Ireland from Great Britain which might otherwise incur ‘at risk’ tariffs. For more information, click here.

NEW – Guidance to assist you in finding out what you need to do if you start and end transit movements in Northern Ireland using common and Union transit has been published. For more information, click here.

NEW – DEFRA are working to compile a list of businesses that can take advantage of the authorised GB-NI trader 3-month grace period. The grace period will only cover certain goods: products of animal origin (POAO), composite products, food and feed not of animal origin, and plants and plant products. For more information, including how to assess if your business can be added to the list, click here.

NEW – From 1 January 2021, find out when you will still be able to use CHIEF (for a limited period of time) for declaring goods into or out of Northern Ireland. For more information, click here.

UPDATED – Guidance has been updated with information added about goods for which specific conditions apply when moved from NI to GB and placing qualifying goods on the market in GB. For more information, click here.

UPDATED – Apply for authorisation for the UK Trader Scheme if you bring goods into Northern Ireland from 1 January 2021 guidance has been updated with Information about if you supply goods to a business in Northern Ireland but do not have a fixed address in Northern Ireland. For more information, click here.

UPDATED – Supplying authorised medicines to Northern Ireland from 1 January 2021 guidance has been updated with information which provides assurance that licensing requirements for medicines containing controlled drugs from 1 January 2021 will not be changing. For more information, click here.

UPDATED – Using personal data in your business or other organisation from 1 January 2021: Guidance has been added to include information on the EU-UK Trade and Cooperation Agreement interim bridging mechanism for personal data. For more information, click here.

UPDATED – The Border Operating Model has been updated to reflect the UK’s new Trade and Cooperation Agreement with the EU. For more information, click here.

UPDATED – Guidance on how to trade with other countries if there is no UK trade agreement has been updated with new guidance for Great Britain and Northern Ireland. For more information, click here.

UPDATED – Guidance on how to report supplies of goods and services to VAT-registered customers in an EU country using an EC Sales List has been updated in respect of the end of the Brexit transition period. For more information, click here.

UPDATED – Guidance has been issued about how relevant businesses can claim refunds of VAT incurred on goods in the EU and Northern Ireland using the EU VAT refund system. For more information, click here.

UPDATED – Guidance on using the S&S (Safety and Security) GB Service if you import goods into Great Britain and need to make an entry summary declaration has been updated with information about what to do if the service is unavailable. For more information, click here.

NEW – Guidance on getting a UK Licence for the Community to transport goods by road to or through the EU, Liechtenstein, Norway and Switzerland, and the rules you must follow has been issued. For more information, click here.

NEW – Guidance has been issued to help you find out what you need to do if you are a business or individual using an express carrier (including Royal Mail Group) to move parcels between Great Britain and Northern Ireland. For more information, click here.

NEW – Guidance on which licences and permits you need to operate vehicles with gross vehicle weight above 3.5 tonnes, on international journeys from the UK, has been updated. For more information, click here.

UPDATED – Guidance on which documents you need to carry if you are the driver or a passenger in a lorry or other HGV crossing international borders, has been updated. For more information, click here. Guidance about HGV and trailer documents you need to legally cross international borders in a UK-registered vehicle has also been updated here UPDATED – Guidance on using common or Union transit has been updated to include information about the office of departure process in Northern Ireland for starting your transit movement, from 1 January 2021. For more information, click here.

UPDATED – Information for moving goods through the Port of Holyhead with an ATA Carnet has been updated. For more information, click here.

NEW - Guidance has been issued to help you find out if you need to use the UKCA marking and how to use it here. For guidance on using the UKNI, please click here.

UPDATED - Guidance on trading and moving goods in and out of Northern Ireland has been updated. For more information, click here.

UPDATED - Check if you can declare goods you bring into Northern Ireland not ‘at risk’ of moving into the EU from 1 January 2021. For more information, click here.

NEW - Guidance has been issued with the steps to take if you want to provide a service or set up a business in the UK. For more information, click here.

NEW - Guidance has been issued so that you can find out what you need to do if you hold a .eu domain or want to register one. For more information, click here.

UPDATED - The list of Companies House forms has been updated following the end of the Brexit transition period. For more information, click here.

NEW - Guidance, explaining the main features of UK Economic Interest Groupings (UKEIG) and sets out the main differences between the UKEIG and EEIG corporate forms, has been issued.

For more information, click here.

UPDATED - Guidance on how to find out if your business will need to change its company registration following the end of the Brexit transition period has been updated. For more information, click here.

NEW - Guidance has been issued on what action you need to take regarding data protection and data flows with the EU/EEA. For more information, click here.

NEW - Guidance has been issued with information on retaining protection in the UK for EU Intellectual Property rights. For more information, click here.

UPDATED - There have been changes to UK intellectual property law to ensure the UK’s departure from EU IP systems. For more information, click here.

UPDATED - Guidance covering the impacts on UK right holders and users been updated to reflect that the end of the transition period. For more information, click here.

NEW - Guidance has been published on how the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland). 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

NEW - 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 ensure they are prepared for the end of the transition period, when an independent GB chemical regimes will be in place from 1 January 2021. 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.

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.

Regulation NEW – Guidance has been published clarifying the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) from 1 January 2021. For more information, click here.

NEW – MHRA have published new guidance on how the 150-day assessment timeline for all high-quality marketing authorisation applications works, and how to apply. Please find out more here.

NEW – MHRA have published new guidance on how the rolling review process for marketing authorisation applications will work, and how to apply. Please find out more information here.

NEW – The MHRA have published new guidance providing procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations from 1 January 2021. Please find more information here.

UPDATED – MHRA guidance on variations to Marketing Authorisations from 1 January 2021 has been updated. Please find more information here.

UPDATED – MHRA guidance on renewing Marketing Authorisations for medicines from 1 January 2021 has been updated. Please find more information here.

UPDATED – Product safety and metrology guidance has been updated with new guides for Great Britain and Northern Ireland added on Regulation 765/2008 on Accreditation and Market Surveillance. For more information on Great Britain guidance, click here. For more information on Northern Ireland guidance, click here UPDATED – Guidance on submissions related to human medicines needing to be submitted directly to the HMRA from 1 January 2021 has been updated with more information. For more information, click here.

NEW – MHRA have published guidance on the decentralised and mutual recognition reliance procedure for marketing authorisations. Please find more information here.

NEW – MHRA have published guidance on the European Commission Decision Reliance Procedure and how to apply for marketing authorisation via this procedure. Please find more information here.

NEW – MHRA have published guidance on the Unfettered Access Procedure for marketing authorisations approved in Northern Ireland. Please find more information here.

NEW - Guidance has been issued on how and when to register updated packaging and information leaflets when new national marketing authorisations have been issued. For more information, click here.

NEW – MHRA have published new guidance for retailers on supplying over-the-counter medicines to Northern Ireland. Please find more information here.

NEW – The MHRA have published new guidance on supplying medical devices to Northern Ireland. Please find more information here.

Workforce NEW - Guidance on how to get professional qualifications obtained in the EU, Switzerland, Norway, Iceland and Liechtenstein recognised in the UK has been issued. For more information, click here.

Business Support UPDATED – Guidance on how tests and testing kits for COVID-19 work 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

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To provide feedback on MHRA engagement please contact engagement@mhra.gov.uk 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