Archive for 2012

New rates of EMA fees for orphan drugs from 1.1.2013

Monday, December 17th, 2012 in News

Companies applying for designated orphan medicines pay reduced fees for regulatory activities to the EMA. This includes reduced fees for marketing-authorization applications, inspections before authorization, applications for changes to marketing authorizations made after approval and annual fees. Please find here a letter by EMA informing about the changed rates for fee ... read more...

Meeting Documents – Art 57 Implementation Working Group Meeting – 05/12/2012

Thursday, December 6th, 2012 in News

Please find enclosed, the meeting documents of the Art 57 implementation working group meeint on 5 December 2012: Entry-of-IMP-data-via-EudraCT-application Entry of IMP data_products and substances_updated Questions received via Art57 helpdesk for discussion XEVPMD Organisation CV - data quality review Agenda item 4.1 Agenda item 4.2 Draft XEVPRM FAQs  

Presentations from 6th Stakeholder Meeting on Pharmacovigilance

Thursday, November 15th, 2012 in News

Please find enclosed, the presentations from the 6th Stakeholder Meeting on the implementation of the new pharmacovigilance legislation. - H. Lee - Commission update 1 - E. Weidlich - PhV Audit Module - J. Ahlqvist-J. Garcia - GVP Module XV - Safety communication - J. Garcia GVP Module XV - Safety communication final - M. ... read more...