The following
groups will need to take access to MHRA Submissions in order to start submissions
from 1 January 2021:
- All pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities
- All medicines clinical trial sponsors wishing to make clinical trial submissions (Initial Applications, Substantial Amendments, End of Trial Notifications and Developmental Safety Update Reports (DSURs)) to the Agency
- E-cigarette producers
- Brokers of medicinal products
Gaining
access to MHRA submission can be divided into three parts –
- User registration – the end to end process for adding an initial company administrator
- Add a new user – add an internal colleague as a user or company administrator
- Add a new external user – add a third-party consultant/consultancy as a user or company administrator
Prerequisite
points💬 –
- The
first Person In any organization who completes the registration process will
become the first responsible administrator. Hence it is advisable that right person with appropriate consensus/permission becomes company administrator (registering
as company administrator without permission could cause unnecessary confusion
and delay to the company’s operational activities.
- Access
of 5-digit company number(s) if any organization has previously submitted to
the MHRA. (If you have not submitted to the MHRA, please email reference.data@mhra.gov.uk
as you will need to register as a new company prior to beginning this process).
- All
third-party consultants/consultancies have their own 5-digit company number and
have registered for MHRA Submissions using that number.
New Users
New users can straightway reach to MHRA account request page
via the following link-
https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration
Source: MHRA- www.gov.uk