News Archiv

EU: Best Practice Guide for the submission and processing of variations in MRP updated by CMD(h)

The CMD(h) - Coordination Group for Mutual Recognition and Decentralized Procedures - Human has relased an updated revision 9 of the "Best Practice Guides for the Submission...[more]

EU: CMD(h) releases updated Q&A for the submission of variations

The Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)) has released an updated version (revision 6) of the "Q/A-List For The Submission...[more]

EU: EMA reminds applicants on the mandatory use of EU M1 spec 1.4 for EU eCTDs

The European Medicines Agency EMA reminds all applicants that from 1 July 2010 the EU regional Module 1 v1.4 (see our related News Article) must be used for all eCTD submissions...[more]

EU: EMA releases updates regarding PIM

The European Medicines Agency has released some updated information regarding PIM (Product Information Management).

The recent update includes:

New Q&A (#10) in the General...[more]

EU: Updates from electronic Application Form project released

Updates has been released concerning the electronic Application Form (eAF) project by the EMA. The implementation of the electronic Application Form is considered a key...[more]

EU: CMD(h) releases updated Q&A list for the submission of variations

The Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)) has released an updated version (revision 5) of the "Q/A-List For The Submission...[more]

EU: New version of electronic submission / paper submission requirements for new applications released

The CMD(h) (Coordination Group of Mutual Recognition and Decentralized Procedures - Human) has released a new version (Rev 6) of the individual EU Member States requirements for...[more]