Penthrox Regulatory Approval in UK and Europe
6 May 2015
Penthrox successfully completes its Decentralised Regulatory Approval Procedure in Europe
Medical Developments International Limited (ASX: MVP) is delighted to announce that the Medicine and Healthcare products Regulatory Agency (“MHRA”) has issued the Final Assessment Report with the support of France, Belgium and Ireland authorities noting all outstanding issues pursuant to the Decentralised Procedure have been successfully resolved and Penthrox is approvable.
MVP now moves into the National Phase which is a purely administrative process whereby each of the countries approve the translation of the labelling and product information, and registers Penthrox as being available for sale in their national records. The National Phase should take 30 days and thereafter Marketing Authorisation will be issued and Penthrox will be available for sale in these markets.
For more information click on the following link ASX Announcement – Regulatory Approval in UK and Europe