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

EU Wants ‘Written Guarantees’ From UK On New Medicine Rules

Executive Summary

Numerous political and legislative procedures will be needed before new rules on the UK-wide approval of new medicines and their marketing in Northern Ireland can be implemented.

You may also be interested in...



EU Parliament OKs Law Ending Validity Of Centralized Drug Approvals In Northern Ireland

Giving the UK regulator the power to issue UK-wide marketing authorizations for products that fall within the scope of the EU centralized procedure will reduce the regulatory burden on companies marketing medicines in Northern Ireland.

UK-EU Northern Ireland Deal Reinstates ‘Single UK Market For Medicines’

Under the landmark “Windsor Framework” agreed by the UK and the EU, medicines will take the “green lane” from Great Britain to Northern Ireland, while the UK regulator will have UK-wide responsibility for all drug approvals. In addition, the provisions of the EU Falsified Medicines Directive will no longer apply in Northern Ireland.

Changes To EU Pharma Reform: More Questions Than Answers?

In the first of a series of articles on the future direction of the EU pharmaceutical reform proposals, the Pink Sheet looks at the new uncertainties created for the drug industry after the European Parliament voted through a series of amendments in the area of regulatory data protection.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147870

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