DHSC have provided the following update for stakeholders:
DHSC would like to invite you to a webinar at 2pm on Thursday 16 March, on the recent announcement from the Government on the significant changes to medicines in the Windsor Framework. We will be joined by colleagues from MHRA, and will be discussing:
- The replacement of the EMA by the MHRA as Northern Ireland’s regulator for all novel medicines, making the MHRA the sole medicines regulator for Northern Ireland.
- The disapplication of the Falsified Medicines Directive in Northern Ireland.
- The requirement to add a ‘UK-only’ marking to UK medicine packs.
- Simplifications to customs and Sanitary and Phytosanitary (SPS) processes that will significantly reduce requirements on traders.
We are working through the details of what this means for all products and supply chains and will revert with further information on these arrangements in due course. Further information is available on gov.uk here.
There are no changes that industry needs to make immediately, and guidance will be released in due course.
You may have already received this invitation already, however we thought that it may be of benefit to share with you.
Please register for the webinar here, and place a hold in your diary for 2-3pm on Thursday 16 March. We will provide a calendar invite to everyone who has registered closer to the time. Please also feel free to forward the link of this registration form to any other colleagues you feel would be interested.
To view all of our previous webinars, along with important news stories and documents, please visit our SharePoint site. If you haven’t signed up, you can do so by emailing supply.engagement@dhsc.gov.uk.
If you are having any issues with the sign-up process, please email supply.engagement@dhsc.gov.uk.
