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

End Of Road For ‘Too Complex’ EU Pilot On Splitting Marketing Licenses

Executive Summary

EU regulators have pulled the plug on a pilot program on splitting mutual recognition and decentralized procedure licences. Instead of promoting harmonization of marketing authorizations across the EU and helping companies with their marketing strategies, it has led to more problems.

You may also be interested in...



EU Extends Pilot On Splitting Mutual Recognition/Decentralized Procedures

Drug companies in the EU are getting more time to experiment with splitting their mutual recognition and decentralized procedure licences to help with their marketing strategies.

EU To Test Merging & Splitting Of Licences Under Mutual Recognition/Decentralized Procedures

The CMDh - the EU group that co-ordinates the approval of human medicines evaluated through the mutual recognition and decentralized procedures - has launched a pilot project that will allow drug companies to merge or split MRP/DCP lines to suit their business strategies1.

EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications

Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS140639

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