The MHRA will shortly be rolling out a new web application for the submission of Wholesale Distribution Authorisations WDA(H) applications and new registrations for Active Substance manufacture, importation or distribution (API).
The launch of the portal will take place in two stages. The first stage will commence on 22nd April 2014 and will allow companies to apply for new WDA(H) and new Active Substance manufacture, importation or distribution (API) registrations. During this time, submission of WDA(H) and API variations and compliance reports must continue to be done via email to email@example.com. The second stage, details and date of implementation not yet confirmed, will allow variations to WDA(H)s and API registration variations/Annual compliance reports to be submitted via the portal.
From the 28thApril 2014 the MHRA will only accept portal applications for new Wholesale Distribution Authorisations or new Active Substance manufacturer, importation or distribution registrations. Applications which are pending and those which were sent prior to this date will still be processed but those posted or e-mailed after this date will be referred back to the applicant for submission via the portal.
If you would like more information on this, please contact us via our Contact page.