The Co-ordination Group for Mutual Recognition and Decentralized Procedure - Human (CMD(h)) has released an updated version (Rev 6, April 2011) of the table listing additional...[more]
An updated list of addresses and distribution requirements for Periodic Safety Update Reports (PSURs) has been released today by the European Medicines Agency. The list contains...[more]
The European Medicines Agency announced today the closure of the PIM project as the Agency is currently undertaking a review of its business strategy and IT system requirements in...[more]
The European Medicines Agency has released a new version of the 'Post-Authorisation Procedural Advice Human Medicinal Products' applicable for human medicinal products in scope of...[more]
The EU Telematics Implementation Group for electronic submissions (TIGes) has updated the recently released harmonized validation criteria for eCTD and NeeS (see our related News...[more]
The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)) has recently updated several guidance documents concerning the submission, processing...[more]
In a recent meeting of the Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)), it was decided to inform applicants that as of 1st June 2011,...[more]
