Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Brexit Already Affecting UK Regulator’s Role In Marketing Authorizations

Executive Summary

A recent stakeholder meeting at the EMA heard that because of Brexit, the UK will soon no longer be able to play the role of rapporteur for initial EU marketing authorization applications. Meanwhile, the EMA is working with the other 27 EU member states to ensure an “orderly redistribution” of the work currently done by the UK regulator, the MHRA.

You may also be interested in...



Massive Reallocation of UK Rapporteurships Likely As EMA Plans For Future; UK’s Interim Role Uncertain

If Brexit means the UK no longer plays a part in the EU drug regulatory system, responsibility for the ongoing oversight of almost one in four of all the human medicines that have ever been approved under the centralized procedure will have to be reassigned from the UK to other member states. What Brexit means for the UK’s role as a key player in the regulatory system in the meantime is the subject of speculation.

Industry & Regulators To Align Advice on COVID-19 Vaccine Updates

A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.

Denmark Planning To Impose Drug Stockpiling Obligations From July

A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121862

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel