Office for Life Sciences Bulletin - 30th October 2020

Office for Life Sciences Bulletin – 30 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

News NEW - The UK–Japan Comprehensive Economic Partnership Agreement (CEPA) is the first major trade deal that the UK has struck as an independent trading nation. This deal could boost trade between the UK and Japan by over £15 billion and drive economic growth in the long run. A summary document has been published, giving an overview of the benefits for UK businesses, by sector.

NEW - Novel COVID-19 Antibody therapy candidates have been identified by the UK BIA Antibody Task Force A leading UK biotech consortium developing antibodies for treating COVID-19 has reached a major milestone – the identification of differentiated antibody combinations that will be taken forward for further development as an antibody “cocktail”.

The consortium – the UK BIA Antibody Taskforce of which the National Institute for Biological Standards and Control is a member – developed an accelerated and rigorous multifaceted approach to create a pool of over 600 novel candidates and identified a set of antibodies with the greatest potential.

Please see further information on the BioIndustry Association’s website.

Transition Guidance NEW – The MHRA have sent letters to all Marketing Authorisation Holders of Centrally Authorised Products (CAPs) to inform them of the actions the MHRA intends to take concerning CAPs and the actions the MHRA needs them to take. Please find more information here.

UPDATED – MHRA guidance on pharmacovigilance procedures from 1 January 2021. The guidance has new information around products placed on the market in Northern Ireland.

Please find more information here.

UPDATED – MHRA guidance on renewing Marketing Authorisations for medicines from 1 January 2021 has been updated, with added information on renewals for marketing authorisations via unfettered access. Please find more information here.

NEW – The MHRA have published new guidance on variations to Marketing Authorisations (MAs) from 1 January 2021. Please find more information here.

UPDATED – MHRA guidance on Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021 has been updated with new information around Northern Ireland.

Please find more information here.

NEW – The MHRA has published guidance on new assessment routes from 1 January 2021. Please find more information here.

UPDATED – MHRA guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021 has been updated. Please find more information here.

NEW – Guidance for manufacturers of biological medicines - independent batch release in the United Kingdom from 1 January 2021 can be found here.

NEW – Guidance explains criteria for allocating ECMT permits and what hauliers need to do.

Please find more information here. Updated guidance on about preparing to apply for ECMT permits for 2021 between 2 November and 20 November 2020 is also available here.

UPDATED – Guidance on importing and exporting plants and plant products from 1 January 2021, including information about making advance notifications for all regulated consignments to the UK is available here.

UPDATED – Guidance on REACH chemical regulations when using, selling or importing chemicals to the EU has been updated, including information on grandfathering, tonnage deadlines and how UK downstream users can notify the HSE. Please find more information here.

UPDATED – Please find an updated list of customs agents and fast parcel operators who can assist with submitting customs declarations is available 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.

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.

Monday 2 November – Chemicals Businesses webinar, please register here Thursday 5 November – The ‘Regulations on Manufactured Goods’ webinar will cover changes to the UK regime for goods that currently use the CE marking, the new UKCA marking and what you will need to do to place certain goods on the GB, NI and EU markets from 1 January 2021. Register for free 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.

Workforce

NEW – Guidance on working in and travelling to the EU from 1 January 2021 for transport operators, workers, visitors and passengers has been published here.

NEW – The winter support schemes have been significantly increased to ensure livelihoods and jobs across the UK continue to be protected in the difficult months to come, supporting jobs and helping to contain the virus. Please find more information here.

NEW – The Job Support Scheme (JSS) provides additional support to help employers retain their employees. The scheme will be open from 1 November and run for 6 months. Please find more information here.

UPDATED – The Self-Employment Income Support Scheme Grant is being extended from 1 November 2020. The online service for the next grant will be available from 14 December 2020. HMRC will provide full details about claiming and applications in guidance on GOV.UK in due course. Find out if you're eligible and how much you can get.

UPDATED – Guidance on claiming back statutory stick pay paid to employees has been updated so employers can ask for a ‘shielding note’ or a letter from their employees' doctor or health authority advising them to shield because they’re at high risk of severe illness from coronavirus. Please find more information here.

Business Support UPDATED – Guidance on 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