The new Pharmacovigilance Legislation (GVP modules) in Europe is an attempt to harmonise and rationalise a complex set of regulations, which are out of date and purpose. The main objective is to define clear roles and responsibilities and also ensure a better interaction between the Industry and regulatory assessors. Regulators have long since requested from pharmaceutical companies a more proactive approach to the definition of the Benefit/Risk profile of their products and we have described this here and here. This translates in additional sections, which will be required for periodic reporting documents (Psur, Pbrer), in particular a benefit evaluation and a benefit characterisation. The new Pbrer will entail a complete evaluation of the product’s Risk/benefit profile for the period under review containing assessment of safety information from all sources (including ongoing clinical trials). The Risk Management plan, on the other hand, will shift its focus on the description of data collection methods and the management of known safety issues (risk minimisation activities). The submission frequency of Pbrers will become variable, mainly based on each product’s safety profile (the higher the risk, the higher the submission frequency). The submission schedule will be controlled by a legally binding list of substances published by EMA, called Union Reference Dates (URD). The time that companies will be allowed to produce Pbrers will be 70 days from data lock point for Pbrers covering periods of 6 or 12 months and 90 days after data lock point for pbrers covering periods of more than 12 months.