News Archive

EMA mandates eSubmission Gateway or web client for eCTDs in the Centralized Procedure

Flag of EU

The European Medicines Agency (EMA) reminds Marketing Authorization Holders and Applicants in a recent press release that beginning March 01, 2014 all eCTD submissions must be...[mehr]

EMA updates Pre-authorization Procedural Advice

Flag of EU

The European Medicines Agency has released an updated version of their "Pre-authorisation procedural advice for users of the centralised procedure", dated February 2014...[mehr]

New versions of the EU electronic Application Forms released (MAA, variation, renewal)

Flag of EU

The electronic Application Forms for Human Medicinal Products have been updated. The update comprises the forms for

Initial MAAVariationsRenewals

and includes for each of the...[mehr]

CMDh releases new submission requirements for MRP, DCP and national procedures

Flag of EU

Updated versions of the submission requirements overview tables have been released by the CMDh summarizing the national submission requirements of the EU/EEA Member States for...[mehr]

EMA encourages applicants to submit quality Type I variations for 2013 by end of November


The European Medicines Agency (EMA) is advising marketing-authorisation holders to submit any quality type-IAIN and type-IA variations for 2013 by Friday 29 November wherever...[mehr]

Registration procedures for EudraVigilance changed for MAHs and Sponsors, new instructions for virtual affiliates

Flag of EU

The EudraVigilance registration procedures for Marketing Authorisation Holders (MAHs) and Sponsors have changed. Additional requirements and updated registration forms have...[mehr]

EDQM releases new version of the guidance for electronic and paper submissions for CEP applications

Flag of EU

The EDQM has released a revision of their "Guidance for electronic and paper submissions for Certificates of Suitability (CEP) applications". The revised document...[mehr]

Treffer 36 bis 42 von 197

< Vorherige








Nächste >

© 2007 - 2018 | Exalon GmbH | Fritz-Reichle-Ring 2 | 78315 Radolfzell | Germany | Phone: +49 (0)7732.939.1650 | Fax: -.1655 |