Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

EMA Addresses UK Exit

Jul 5, 2017, 23:13 PM
News Source Link:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500228739.pdf
RegulatoryNewsDate:
Jul 5, 2017, 16:34 PM

On May 2, EMA released a Q&A document in response to the United Kingdom’s withdrawal from the European Union. This document covers procedures for marketing authorization holders currently established in the United Kingdom, orphan designation procedures, role of Qualified Persons, etc. EMA expects to update this document in the future.

In addition, a recent meeting of EMA’s Management Board covered how the Agency will handle the UK’s plans to exit the European Union. The Agency is working on the assumption that the UK will be considered a third country outside the EU and European Economic area as of March 30, 2019, and will continue to participate in all formal meetings and retain its speaking and voting rights.

regulatory-news-regions:
  • Europe