Office for Life Sciences Bulletin – 26 February 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 government has welcomed the European Commission's draft data adequacy decision which recognises the UK’s high data protections standards and set out that the UK’s standards are ‘adequate’. The ‘bridging mechanism’ will remain in place until June 30 or until the adequacy decisions come into effect, whichever is sooner. NEW – The Goldacre review, launched by the government on 9 February, will focus on the more efficient and safe use of health data for research and analysis for the benefit of patients and the healthcare sector. The Secretary of State for Health and Social Care has asked Dr Ben Goldacre to undertake this rapid review and report his findings in April. If you would like to get in touch about the review or share your experience of using health data for research, please contact goldacrereview@dhsc.gov.uk before 15 March 2021. For more information, click here. NEW – The Prime Minister, Rt Hon Boris Johnson MP, announced the government’s roadmap to cautiously ease lockdown restrictions in England on Monday 22 February. The roadmap can be found in full here.
Regulation
REMINDER – The grace period for registering Active Implantable, Class III and Class IIb implantable medical devices and IVD list A medical devices is approaching on 1 May 2021. Please see MHRA guidance with details of how to register. NEW – The MHRA have published the Public Assessment Report for the Moderna COVID19 vaccine. The scientific report explains how this product was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use the vaccine. UPDATED – The MHRA have updated a number of documents on the Oxford University/ AstraZeneca COVID-19 vaccine. For more information, click here. UPDATED – The MHRA have updated guidance on how investigators and sponsors should manage clinical trials during COVID-19 to include a section on management of COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials. For more information, click here. UPDATED – The MHRA have updated guidance on COVID-19 tests and testing kits, and the specifications for manufacturers. The document for industry and manufacturers has been updated to include the new UK Conformity Assessed (UKCA), CE and CE UKNI (Northern Ireland) markings. UPDATED – The MHRA have updated the list of medical devices given exceptional use authorisations and the list of devices no longer covered.
Transition Guidance UPDATED – Guidance on the Goods Vehicle Movement Service has been updated. The Goods Vehicle Movement Service is for traders, hauliers and carriers who use a UK Port.
•
Guidance for hauliers has been updated here.
•
Guidance on registering for the Goods Vehicle Movement Service has been updated with new information about who should register for the service. For more information, click here.
•
Information about what you need to do to get a goods movement reference has been updated. For more information, click here.
•
Guidance to check if a goods movement reference is valid has been updated with information about hauliers moving goods from the EU to GB. For more information, click here.
UPDATED – Guidance on permits to travel to or through European Conference of Ministers of Transport (ECMT) member countries has been updated. Information
about applying for short-term permits has been updated - you can now apply for these for the rest of 2021. For more information, click here. UPDATED – The most recent HMRC newsletter, has been updated with information on ‘French ports with the ‘smart border’ system’. For more information, and to view recent editions of the newsletter, click here. UPDATED – The list of agents and operators who can help submit customs declarations has been updated. For more information, click here. UPDATED – Guidance on moving goods from Great Britain to Northern Ireland by parcel has been updated. This information can be found in the section ‘Moving excise goods’. For more information, click here. UPDATED – Guidance on how you import from, and export to, Iceland and Norway has been updated. For more information, click here.
Events Keep up to date with all the latest available webinars: • • • • • •
• •
•
Find videos to support your business during coronavirus disruptions here. UPDATED - Watch past HMRC videos on coronavirus here and UK transition here. A new YouTube video on exporting to the EU is now available to watch on-demand. Find videos to help you learn more about trading with the EU from 1 January here. Click here to view a list of webinars for organisations that trade with the EU you can watch live or on demand. The Home Office has created a podcast episode to help you prepare for the pointsbased immigration system. Listen now to Business and the Future of Immigration in 2021. Also available on Spotify and Apple. 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 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. BEIS has launched a series of on demand videos, to help businesses familiarise themselves with the new rules. Topics include importing and exporting, trade, Rules of Origin, tariffs, data, and audit and accounting. To view the videos, click here. The Border and Protocol Delivery Group have produced a video series on border readiness at the end of the transition period on Short Straits and Landbridge and Direct Maritime Routes. To view a webinar and Q&A session on the issues arising from goods moving from GB to the EU, via the short straits please click here.
NEW – DHSC are holding open sessions on various topics in relation to the Goldacre Review, which are advertised on Eventbrite. Register your interest below: • Health Data Researchers: 01/03/2021, 2-3:30PM • Patients and Public: 03/03/2021, 10-11:30am • Data Ethicists: 10/03/2021, 10-11:30 am • Professional Bodies: 10/03/2021, 12-1:30pm • Operational Researchers: 10/03/2021, 2-3:30pm
• •
SMEs: 15/03/2021, 10-11:30am Medical Research Charities: 17/03/2021, 3:30-5pm
Monday 1 March: DEFRA are hosting a webinar on Importing Products of Animal Origin (POAO) from the EU into GB. Register 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 – HMRC webinar on completing customs import declarations. To register and find a date, please click here. Various dates - The National Cyber Security Centre is running a series of free cyber security webinars and talks aimed at UK businesses of all sizes, educational institutions and charities. For more information, click here.
Useful Links • • • • • • • • • • •
• •
Gov.uk/transition provides a central hub of resources You can sign up to email alerts on GOV.UK at this link. Sign up for Home Office email updates about 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. Register for HMRC’s free Trader Support Service if you are moving goods between Great Britain and Northern Ireland. The most up-to-date guidance on the Northern Ireland Protocol is on GOV.UK, including information on moving goods into, out of, or through Northern Ireland. VAT guidance about the conditions for zero rating VAT on the goods you export, and what you should do when you export goods in specific circumstances. A list of government Brexit transition helplines organised by theme and key actions for businesses has been published. To view this, click here. 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 o
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