GMP: Revised Guideline on Renewals in the Centralised Procedure Effective
19.07.2012
The document describes a 120-day timetable presenting the respective actions at specific times which the applicant must observe. Moreover, the Guideline provides detailed information on the documents to be submitted.
The source of the news: http://www.gmp-compliance.org/eca_news_3209_3788.html
SciencePharma
