GMP: Transitional Regulations for the New Pharmacovigilance Package: Commission\'s Q&A Document provides Clarity

Several provisions for pharmacovigilance have been newly defined among others with Regulation (EU) No 1235/2010 and Directive 2010/84/EU from 2010. Marketing authorisation holders are now confronted with a complex set of rules which raises quite a number of questions in the current transition period