Office for Life Sciences Bulletin – 1 September 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 is a special bulletin to inform the life sciences sector that the MHRA has published detailed guidance on how medicines and medical devices will be regulated at the end of the Transition Period, in both a negotiated and non-negotiated outcome with the EU. This is to provide 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 Anisha.Visram@beis.gov.uk
Guidance On 1 September 2020, the MHRA published the first of their formal regulatory guidance on the post transition period. This included guidance on Clinical trials, Medical Devices, Licensing, Importing and exporting, IT systems, Pharmacovigilance, and Paediatrics which can be found at the central MHRA landing page here. On 1 September 2020 the department for Business Energy and Industrial Strategy published guidance for other manufactured goods including on the design of the UKCA mark which is relevant to part of the Medical device’s guidance. The link to the BEIS guidance can be found here.
Events The Department of Health and Social Care and the MHRA will be hosting a webinar from 9:30am on Thursday 3rd September to talk through the guidance and answer questions. Click here to register to attend the webinar.
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