Regulatory Affairs Newsletter

Horizon scanning at the MHRA leads to a proposed new framework to enable the supply and increase in the availability of innovative new medicinal products made at the point of care to patients. Change made: First published.

Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation. Change made: Updated ‘Open List’

Guidance for adult social care providers to comply with information provisions under section 99 and section 100 of the Health and Care Act 2022. Change made: First published.

The thirteenth two-monthly report on which powers in the Coronavirus Act 2020 are currently active. Change made: Added a correction slip to the report, detailing revisions to the document on pages 4 and 11.

Page summary: Use the lists to check your business in Great Britain (England, Scotland and Wales) or one of the Crown Dependencies (Jersey, Guernsey and Isle of Man) is approved to export to the EU, and find out what your TRACES number is.   Change made: Updated the lists of businesses approved to export to the EU.

Places are filling up for the BIVDA Joint Working Party and Regulatory Affairs Seminar! If you are looking to attend Working Party meetings or the Regulatory Affairs Seminar, we encourage you to register as soon as possible to prevent disappointment. The agenda for these are being finalised, but the seminar is aiming to cover: Summary of what is going on…

The BIVDA Joint Working Party and annual Regulatory Affairs Seminar is approaching on 12-13 October. Members are encouraged to book tickets as soon as possible to prevent disappointment – places are filling up fast!