The Medicines and Healthcare products Regulatory Agency (MHRA) have released guidance on how to make regulatory submissions for all regulatory and periodic vigilance submissions.
This will include clinical trial applications and marketing authorisations, renewals and variations, paediatric investigation plans (PIPs), periodic safety update reports (PSURs) and development safety update reports (DSURs), these will be required to be submitted via a new MHRA e-Submissions Portal.
For submitting and receiving expedited vigilance reports (ICSRs, SUSARs and ASPRs), there will be a separate portal (more information to follow in due course from MHRA); however the e-SUSAR portal will still be available. The new MHRA e-Submissions Portal is planned to be made available prior to 29 March 2019 in the event of a no‑deal Brexit scenario, and all companies, including Sponsors and MAH’s will need to register for access to the portal with their MHRA five digit company number.
On the 04-Mar-2019, the MHRA released two guidance documents on gaining access and managing users for the MHRA submissions portal:
- User Reference Guide – Gaining Access to MHRA Submissions
- User Reference Guide – Managing users on MHRA Submissions
QVigilance are pleased to announce that we have now registered a number of members of our Pharmacovigilance team in the MHRA submissions portal and are ready to support our customers in making electronic submissions of PSURs and DSURs to the MHRA from 29-Mar-2019, if there is a no-deal Brexit!
Further information can be found on the MHRA website and webinars are available on the process: https://www.gov.uk/government/publications/how-to-make-regulatory-medicines-submissions-to-the-mhra-if-the-uk-leaves-the-eu-with-no-deal