Making Submissions Related to Human Medicines to the MHRA in a No Deal Scenario
MHRA sets new process for Pharma Submissions if UK leaves the EU in a no deal scenario. Pharmaceutical companies and clinical trial sponsors were directed to follow new guidelines for regulatory submissions that would have to be directly submitted to the UK’s Medicines and Health products Agency (MHRA) if Britain leaves the EU in a no deal scenario.
The MHRA is making preparations to ensure that in the event they leave the EU with no deal, you can continue to submit regulatory and notification information to the UK
Before getting started – guidance
Three short video demos are provided below which cover all aspects of the user access management process – these steps will enable your organization to gain access and manage user permissions for using MHRA Submissions.
You can access these three videos from below link:
https://mhra.sharefile.com/share/view/s27ae84cf5ad4aa3a
There are two user reference guides which contain step by step guidance on the processes:
User Reference Guide: Gaining Access to MHRA Submissions from below link
User Reference Guide – Managing users on MHRA Submissions
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/783370/URG_-_Managing_users_on_MHRA_Submissions.pdf
For more detailed information refer below link
https://www.gov.uk/guidance/making-submissions-to-the-mhra-in-a-no-deal-scenario
