An agency of the European Union Presented by: Noël Wathion Head of Unit, Patient Health Protection HMA – Human Agenda item 3: Implementation of the New Pharmacovigilance Legislation Status Report March 2011 HMA Meeting, April 2011 Visegrad, Hungary

Implementation of the New Pharmacovigilance Legislation - Status Report March Status of the preparation/finalisation of the various deliverables Outcome of the March 2011 Management Board (MB) discussion on the implementation of the legislation EMA approach on the (re-)design of the business processes related to the implementation of the pharmacovigilance legislation Final list of Member States’ representatives in the EMA/Member States Project Teams Status Report March 2011: Four Aspects

Implementation of the New Pharmacovigilance Legislation - Status Report March Preparation of the deliverables is on track Priority has been given to the preparation of the EMA technical contribution to the 7 Implementing Measures (as agreed with the European Commission) Status of Deliverables (1/2)

Implementation of the New Pharmacovigilance Legislation - Status Report March Concept Papers have been prepared in the following fields: –Pharmacovigilance audits –Public hearings –Web portal –Coordination of safety announcements –Transparency Status of Deliverables (2/2)

Implementation of the New Pharmacovigilance Legislation - Status Report March MB discussion focused on the implementation of aspects related to EudraVigilance and EU TCT MB agreed with the EMA proposals, emphasising that this is a strategic steer and that the implementation needs to be closely monitored MB will discuss at a later stage the other IT deliverables Outcome of the March 2011 MB Discussion (1/3)

Implementation of the New Pharmacovigilance Legislation - Status Report March More specifically the MB reached the following conclusions: –Support to the conduct of an EudraVigilance audit in Q –Support to the development of a subset of functionalities required for the EudraVigilance audit (including a set of KPIs) –Support to transitional measures for pharmaceutical industry to comply with the 2 July 2011 deadline for the electronic submission of information on human medicines Outcome of the March 2011 MB Discussion (2/3)

Implementation of the New Pharmacovigilance Legislation - Status Report March More specifically the MB reached the following conclusions (cont’d): –Support to maintaining the EudraVigilance system (data quality management, support of EVDAS, revised implementation of the EudraVigilance Access Policy) until the new functionalities are implemented Outcome of the March 2011 MB Discussion (3/3)

Implementation of the New Pharmacovigilance Legislation - Status Report March For all EMA business processes (existing and new ones) business process mapping will be organised to –design simple and efficient processes –improve/simplify existing processes whenever possible Common methodology has been agreed and will be applied “Facilitators” who have been trained will assist in the exercise EMA (Re-)design of Business Processes

Implementation of the New Pharmacovigilance Legislation - Status Report March Final list of Member States’ representatives is included in the meeting documents Composition of EMA/Member States Project Teams

Implementation of the New Pharmacovigilance Legislation - Status Report March Status Report on the implementation of the new pharmacovigilance legislation will be provided at each HMA meeting At the July HMA meeting a list of all deliverables will be provided, together with an identification of the various fora where such deliverables need to be discussed and, where appropriate, agreed upon Next Steps