Update on im plem entation of Pharm acovigilance legislation EU2 8 : Science Medicines Health, a regulatory system fit for the future 06-07 May 2013, Dubrovnik, Croatia Franck Diafouka, Pharmacovigilance and Risk Management Sector, Patient Health Protection Unit An agency of the European Union European Medicines Agency
Content 1. Making of the law and its objectives 2. Hierarchy of rules 3. Prioritised implementation for 2013 4. Project governance structure 1
1. The making of the law and its objectives 2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3 2 0 0 3 : EC decision to undertake an assessment of the Community system of pharmacovigilance
1. The making of the law and its objectives 2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3 2 0 0 5 : I ndependent study completed to 2 0 0 3 : EC decision to map the strengths undertake an and weaknesses of assessment of the the EU system Community system of pharmacovigilance
1. The making of the law and its objectives 2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3 2 0 0 6 -2 0 0 8 : Research, consultation, policy development 2 0 0 7 : Commission strategy to strengthen 2 0 0 5 : I ndependent and rationalise study completed to pharmacovigilance 2 0 0 3 : EC decision to map the strengths undertake an and weaknesses of assessment of the the EU system Community system of pharmacovigilance
1. The making of the law and its objectives 2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3 Decem ber 2 0 0 8 - 2 2 Septem ber 2 0 1 0 : Co-decision procedure until final favourable vote in the European Parliament Decem ber 2 0 0 8 : ‘Pharma package’ (Pharmacovigilance, I nformation to patients and falsified medicines) adopted by the European Commission and transmitted to Council and European Parliament to start the co-decision procedure for pharmacovigilance 2 0 0 6 -2 0 0 8 : Research, consultation, policy development 2 0 0 7 : Commission strategy to strengthen 2 0 0 5 : I ndependent and rationalise study completed to pharmacovigilance 2 0 0 3 : EC decision to map the strengths undertake an and weaknesses of assessment of the the EU system Community system of pharmacovigilance
1. The making of the law and its objectives 2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3 3 1 Decem ber 2 0 1 0 : Publication of Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC ( entry into force in July 2 0 1 2 ) . Decem ber 2 0 0 8 - 2 2 Septem ber 2 0 1 0 : Co-decision procedure until final favourable vote in the European Parliament Decem ber 2 0 0 8 : ‘Pharma package’ (Pharmacovigilance, I nformation to patients and falsified medicines) adopted by the European Commission and transmitted to Council and European Parliament to start the co-decision procedure for pharmacovigilance 2 0 0 6 -2 0 0 8 : Research, consultation, policy development 2 0 0 7 : Commission strategy to strengthen 2 0 0 5 : I ndependent and rationalise study completed to pharmacovigilance 2 0 0 3 : EC decision to map the strengths undertake an and weaknesses of assessment of the the EU system Community system of pharmacovigilance
1. The making of the law and its objectives 2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3 2 5 October 2 0 1 2 : Publication of 3 1 Decem ber 2 0 1 0 : Publication Regulation ( EC) 1 0 2 7 / 2 0 1 2 and of Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 1 2 / 2 6 / EU Directive 2 0 0 1 / 8 3 / EC ( entry into force in June and October ( entry into force in July 2 0 1 2 ) . 2 0 1 3 ) . Decem ber 2 0 0 8 - 2 2 Septem ber 2 0 1 0 : Co-decision procedure until final favourable vote in the European Parliament Decem ber 2 0 0 8 : ‘Pharma package’ (Pharmacovigilance, I nformation to patients and falsified medicines) adopted by the European Commission and transmitted to Council and European Parliament to start the co-decision procedure for pharmacovigilance 2 0 0 6 -2 0 0 8 : Research, consultation, policy development 2 0 0 7 : Commission strategy to strengthen 2 0 0 5 : I ndependent and rationalise study completed to pharmacovigilance 2 0 0 3 : EC decision to map the strengths undertake an and weaknesses of assessment of the the EU system Community system of pharmacovigilance
1. The making of the law and its objectives Promote and protect public health by reducing burden of Adverse Drug Reactions and optimising the use of medicines: • Clear roles and responsibilities • Science based • Risk based/ proportionate • Increased proactivity/ planning • Reduced duplication/ redundancy • Integrate benefit and risk 8
1. The making of the law and its objectives Promote and protect public health by reducing burden of Adverse Drug Reactions and optimising the use of medicines: • Ensure robust and rapid EU decision-making • Strengthen the EU Network • Engage patients and healthcare professionals • Increase transparency and accountability • Provide better information on medicines 9
2. Hierarchy of rules Regulation ( EC) No 7 2 6 / 2 0 0 4 Directive 2 0 0 1 / 8 3 / EC EC I m plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Good pharm acoVigilance Practice ( GVP) 10 10
2. Hierarchy of rules - Commission implementing regulation (EU) No 520/ 2012 • Legally binding • 9 Chapters
2. Hierarchy of rules - Commission implementing regulation (EU) No 520/ 2012 • Legally binding • 9 Chapters Chapter I Pharm acovigilance System Master File Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2
2. Hierarchy of rules - Commission implementing regulation (EU) No 520/ 2012 • Legally binding • 9 Chapters Chapter I Chapter I I Pharm acovigilance Minim um System Master File requirem ents for the quality system s for the perform ance of pharm acovigilance activities Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2
2. Hierarchy of rules - Commission implementing regulation (EU) No 520/ 2012 • Legally binding • 9 Chapters Chapter I I I Chapter I Chapter I I Minim um Pharm acovigilance Minim um requirem ents for the System Master File requirem ents for the m onitoring of data quality system s for in the the perform ance of Eudravigilance pharm acovigilance database activities Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2
2. Hierarchy of rules - Commission implementing regulation (EU) No 520/ 2012 • Legally binding • 9 Chapters Chapter I I I Chapter I Chapter I I Minim um Pharm acovigilance Minim um requirem ents for the System Master File requirem ents for the m onitoring of data quality system s for in the the perform ance of Eudravigilance pharm acovigilance database activities Chapter I V Use of term inology, Com m ission form ats and I m plem enting standards Regulation ( EU) No 5 2 0 / 2 0 1 2
2. Hierarchy of rules - Commission implementing regulation (EU) No 520/ 2012 • Legally binding • 9 Chapters Chapter I I I Chapter I Chapter I I Minim um Pharm acovigilance Minim um requirem ents for the System Master File requirem ents for the m onitoring of data quality system s for in the the perform ance of Eudravigilance pharm acovigilance database activities Chapter I V Chapter V Use of term inology, Transm ission of Com m ission form ats and reports of suspected I m plem enting standards adverse reactions Regulation ( EU) No 5 2 0 / 2 0 1 2
2. Hierarchy of rules - Commission implementing regulation (EU) No 520/ 2012 • Legally binding • 9 Chapters Chapter I I I Chapter I Chapter I I Minim um Pharm acovigilance Minim um requirem ents for the System Master File requirem ents for the m onitoring of data quality system s for in the the perform ance of Eudravigilance pharm acovigilance database activities Chapter I V Chapter V Chapter VI Use of term inology, Transm ission of Risk Managem ent Com m ission form ats and reports of suspected Plans I m plem enting standards adverse reactions Regulation ( EU) No 5 2 0 / 2 0 1 2
2. Hierarchy of rules - Commission implementing regulation (EU) No 520/ 2012 • Legally binding • 9 Chapters Chapter I I I Chapter I Chapter I I Minim um Pharm acovigilance Minim um requirem ents for the System Master File requirem ents for the m onitoring of data quality system s for in the the perform ance of Eudravigilance pharm acovigilance database activities Chapter I V Chapter V Chapter VI Use of term inology, Transm ission of Risk Managem ent Com m ission form ats and reports of suspected Plans I m plem enting standards adverse reactions Regulation ( EU) No 5 2 0 / 2 0 1 2 Chapter VI I Periodic Safety Update Reports
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