Office for Life Sciences Bulletin – 7 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 – On 2 December, the MHRA approved the first COVID-19 vaccine for the UK developed by Pfizer/BioNTech. The decision that the vaccine has met the MHRA’s strict standards of safety, quality and effectiveness was made with advice from the Commission on Human Medicines, the government’s independent expert scientific advisory body. Please see the Decision page on our website for more information about the COVID-19 vaccine. NEW – The National Crime Agency (NCA) are producing an intelligence assessment of the threat of exploitation of the Covid-19 Vaccine by Serious Organised Crime. This assessment will be published very shortly and will address the following questions: 1. To what extent are Organised Crime Groups (OCGs)s aware of and planning criminal opportunities relating to the roll out of a vaccine in the UK? 2. How might previous Covid frauds and criminality indicate intent and capability to exploit the vaccine? 3. What are the indicators of risks emerging? NCA are interested in any information companies would like to share, including: Threats related to: 1. 2. 3. 4.
Fraud (bogus vaccines/lures/identity theft/impersonation etc.) Acquisitive Crime (theft / robbery /OCG activity) Cyber (e-mail phishing, ransomware, impersonation sites etc.) Economic Crime other (ML and Bribery and Corruption)
Have you experienced the targeting by criminals of vaccine related products at facilities or in transit? Have you come across any indications of attempted infiltration by criminals (e.g. approaches to staff via social media or in-person at sites)? Have you encountered cyber enabled fraud (e.g. payment diversion attempts/business email compromise) relating to the vaccine? Are you aware of any counterfeit products in circulation or being offered for sale/importation? Are there particular aspects of the vaccine supply chain that you assess are vulnerable to exploitation by criminals? Are you aware of any threat to your organisation from protest groups?
Please send any replies to NAC.Cross-Cutting@nca.gov.uk mailbox and copy to the NAC.Prosperity@nca.gov.uk mailbox, indicating any handling restrictions you would like to place on your submission.
Transition Guidance NEW – BPDG have set up a new online forum for questions related to customs and borders, please find it here. To post a question, organisations will need to register. Departments have agreed to respond to questions within a reasonable timeframe. NEW – From 1 January 2021, submissions related to Marketing Authorisations (MAs), Active Substance Master Files (ASMFs) and Clinical Trials will need to be submitted directly to the MHRA via MHRA Submissions, the national portal for submitting regulatory and notification information. The registration process is now open and guidance on how to register and gain access to MHRA Submissions can be found on the MHRA Submissions page. The MHRA advises companies that have not registered for MHRA submissions to do so now, to ensure they can make submissions to the MHRA from 1 January 2021. NEW – Guidance has been issued listing the provisions in the CEPA for SMEs here. Please find a technical note to set out how the tariff rate quota (TRQ) scheme in the CEPA will operate here. Please find guidance detailing the changes in the PSR (Product Specific Rules of Origin) that will apply to UK businesses trading with Japan when the EU-Japan EPA no longer applies to the UK here. UPDATED – Guidance has been updated to reflect the latest information about trading under WTO rules from 1 January 2021 if no trade agreement exists between the UK and another country. For more information, click here. UPDATED – Guidance on trading with Japan has been updated with details of how trading will change from 1 January 2021. To view this, click here. UPDATED – Guidance on what action you need to take regarding data protection and data flows with the EU/EEA after the end of the transition period has been updated. For more information, click here.
UPDATED – Guidance for customers and users of Intellectual Property, about how the Intellectual Property system and the Intellectual Property Office will operate after the end of the transition period, has been updated. For more information, click here. UPDATED – Guidance has been updated to reflect how the ‘Written Confirmation’ process for active substances manufactured in Great Britain (England, Wales and Scotland) will be handled from 1 January 2021. For more information, click here. UPDATED - HMRC have released another newsletter in their series. This edition explains the New Computerised Transit System (NCTS) specifically for Northern Ireland, it’s implications and the technical changes to the guarantee reference amounts. To view this, and previous editions, click here. UPDATED – MHRA have updated guidance on pharmacovigilance procedures from 1 January 2021. Please find more information here. UPDATED – MHRA have updated guidance on converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, 'grandfathering' and managing lifecycle changes. 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.
Workforce
UPDATED – Information for employers to help them prepare for the UK’s new point-based immigration system from 1 January 2021 has been updated. The page includes links to a new podcast on the future of immigration. For more information, click here. UPDATED – The online service for claiming the third grant is now available. Guidance has also been updated to provide clarity on verifying your eligibility with HMRC after having a new child. UPDATED – Step-by-step guidance on the Coronavirus Job Retention Scheme has been updated to reflect recent changes to the scheme, and a new key dates guide has also been
published. Use this list of dates to help you submit your claim before it’s too late. Check the step by step guide. UPDATED – Testing guidance for employers: has been updated.
Business Support NEW - The way that opportunities to supply the UK public sector are advertised is about to change. From 23:00 on 31 December 2020, we will publish information on public sector contract opportunities in the UK, on the new Find a Tender Service (FTS). Existing Contracts Finder account holders will be able to use the same login credentials for Find a Tender. You can register now in preparation for its launch on 31 December. If you wish to access public sector contract opportunities in the EU, you may continue to do so via OJEU/TED. Further guidance is available here. UPDATED – MHRA have updated guidance on medical devices given exceptional use authorisations during the COVID-19 pandemic has been updated here. UPDATED – Guidance on how to make your workplace COVID-secure has been updated to reflect the tiered system. UPDATED – Under the Test to Release for International Travel scheme you can choose to pay for a private COVID-19 test. The earliest you can take the test is at least 5 days after you left a destination not on the travel corridor list. If the result is negative, you can stop self-isolating.
The scheme is voluntary and applies to those self-isolating in England only. The Test to Release scheme starts on 15 December. Find out more 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:
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General offers of help from industry: gcfcovid19enquiries@cabinetoffice.gov.uk, or visit this webpage. Share the impact COVID-19 is having on your organisation with intel@beis.gov.uk 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