UK Transition // Industry sector advice
Check and change – 5 steps life sciences companies can take to be ready to go after the transition period
The UK has left the EU, and the transition period will end on 31 December 2020. From January 2021, there will be important changes for businesses.
Here are five things life sciences companies can check and change now to be ready to go. For more actions your business may need to take before January 2021 visit www.gov.uk/transition and use the checker tool.
Comply with UK REACH to trade chemicals in the UK
If you want to place new chemicals on both the EU/EEA (including Switzerland) and UK markets from 1 January 2021, you must follow both EU REACH and UK REACH rules. You must register new chemicals you want to sell on the UK market from 1 January 2021 with the Health and Safety Executive. HSE will publish detailed guidance in October. More information is available here.
Regulatory systems - Apply for licences to trade drug precursor chemicals with the EU from 1 January 2021.
If you trade drug precursor chemicals from 1 January 2021 you may need import or export licences to trade drug precursor chemicals with the EU. You need a domestic licence or registration before you can apply for import or export licences, this depends on the chemical you are trading. Applications usually take 12 to 16 weeks to process. More information is available here.
Be prepared on data protection and data transfers.
If you'’'re a business or organisation that receives personal data from the EU/EEA, you may need to take action on data protection as we transition to our new relationship with the EU. Check how you can legally continue to receive personal data such as names, addresses or payroll details from organisations in the EU or EEA from 1 January 2021. You may need to update your contracts or take other steps.
A UK company that receives customer information from an EU/EEA company, such as names and addresses of customers, suppliers or partners to provide goods or services should check how they can legally keep receiving the data from 1 January 2021.
To understand more about the steps you need to take, visit: https://www.gov.uk/guidance/using-personal-data-after-brexit.
A full list of EU and EEA countries is available at: https://www.gov.uk/eu-eea.
Signpost your current employees to the EU Settlement Scheme
If you employ EU, EEA and Swiss citizens, you can signpost them to the information they need to apply to the EU Settlement Scheme, enabling them to secure their future in the UK. The deadline for applying is 30 June 2021. Find out more here
Use GOV.UK to identify how your business can be ready to sell certain goods in the UK and EU
From the 1 January 2021 the essential requirements and standards that can be used to demonstrate compliance will be the same as they are now. However, there may be other changes you need to make. These are:
Check if you need a new product approval and begin the process as soon as possible – if your product requires third-party approval, you may need a new approval especially if you sell in both UK and EU. Subject to negotiations, from 1 January 2021 the EU will stop recognising UK approvals.
Check if you need to appoint a new authorised representative to act on your behalf – UK-based individuals and legal entities will no longer count as established in the EU, and vice-versa. You may need to appoint someone to undertake certain tasks in the EU or UK.
Speak to your supply chains / distributors and understand new legal duties – make sure your suppliers/distributors/customers understand the actions they need to take. If you distribute EU goods, or have your goods distributed by someone in the EU, you may acquire new legal duties.
Consider what marking / labelling changes apply to your product – you may need to make changes to the information or regulatory markings that appear on your product, for example to reflect changes to product approvals or new representatives you appoint in the EU.
More information is available at: www.gov.uk/transition.
Speak with your lawyer and accountant or visit www.gov.uk/transition for tailored business information and to sign up for email updates.
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