WC500165698

10.2. Timing and message content in relation to MS safety announcements ..................... 36
10.3. Other requests ................................................................................................. 37
11. Other Safety issues for discussion requested by the Member States ... 37
11.1. Safety related variations of the marketing authorisation ........................................ 37
11.2. Renewals of the Marketing Authorisation ............................................................. 37
11.3. Other requests ................................................................................................. 37
11.3.1. Antidiabetics (CAP, NAP) ................................................................................. 37
12. Organisational, regulatory and methodological matters ...................... 38
12.1. Mandate and organisation of the PRAC ................................................................ 38
12.1.1. PRAC Rules of Procedure ................................................................................. 38
12.2. Pharmacovigilance audits and inspections ............................................................ 38
12.2.1. Pharmacovigilance Inspections ........................................................................ 38
12.2.2. Pharmacovigilance audits ................................................................................ 39
12.3. Periodic Safety Update Reports & Union Reference Date (EURD) List ....................... 39
12.3.1. Union Reference Date List ............................................................................... 39
12.4. Signal Management .......................................................................................... 39
12.4.1. Signal Management........................................................................................ 39
12.5. Adverse Drug Reactions reporting and additional reporting .................................... 40
12.5.1. Management and Reporting of Adverse Reactions to Medicinal Products ................ 40
12.5.1. Individual Case Safety Report (ICSR) standard .................................................. 40
12.5.2. Additional Monitoring...................................................................................... 40
12.5.3. List of Product under Additional Monitoring ....................................................... 40
12.6. EudraVigilance Database ................................................................................... 40
12.7. Risk Management Plans and Effectiveness of risk Minimisations .............................. 40
12.8. Post-authorisation Safety Studies ....................................................................... 41
12.9. Community Procedures ..................................................................................... 41
12.10. Renewals, conditional renewals, annual reassessments ........................................ 41
12.11. Risk communication and Transparency .............................................................. 41
12.11.1. Safety Communication .................................................................................. 41
12.12. Continuous pharmacovigilance ......................................................................... 41
12.13. Interaction with EMA Committees and Working Parties ........................................ 41
12.13.1. Working Parties ........................................................................................... 41
12.13.2. Vaccine Working Party (VWP) ........................................................................ 41
12.13.3. EudraVigilance Working Group (EV-EWG) ........................................................ 42
12.13.4. Scientific Advisory Groups (SAG) ................................................................... 42
12.14. Interaction within the EU regulatory network ...................................................... 42
12.15. Contacts of the PRAC with external parties and interaction of the EMA with interested
parties ..................................................................................................................... 42
13. Any other business .............................................................................. 42
13.1.1. EMA move in 2014 to new building................................................................... 42
14. ANNEX I Risk Management Plans ........................................................ 43
14.1. Medicines in the pre-authorisation phase ............................................................. 43
14.1.1. Dolutegravir, abacavir, lamivudine ................................................................... 43
14.1.2. Empagliflozin ................................................................................................. 43
14.1.3. Human fibrinogen, human thrombin ................................................................. 43
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/253432/2014 Page 5/64