MHRA Submission: The Role of Initial Company Administrator

The UK has left the EU, and the transition period after Brexit comes to an end this year. From 1 January 2021, for medicines authorized in Great Britain, Marketing Authorization Holder (MAH), will be required to submit pharmacovigilance...

Read More

How to gain access for performing submissions to the MHRA from 1 January 2021

 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 activitiesAll medicines...

Read More

Marketing Authorization Holders (MAH) should know these 10 things from BREXIT- MHRA Guidance on Pharmacovigilance Procedures

 MHRA has published updated guidance on pharmacovigilance procedures on 01 September 2020 and new rules will be effective from January 2021 (post-Brexit transition period comes to an end this year). 1. General Approach to the operation of pharmacovigilance This document outlines the submission...

Read More