Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems:
Introduction:
This Module contains guidance for the establishment and maintenance of quality assured pharmacovigilance systems for marketing authorisation holders, competent authorities of Member States and the Agency. How the systems of these organisations interact while undertaking specific pharmacovigilance processes is described in each respective Module of GVP.
The definition of a pharmacovigilance system is provided in Article 1 of Directive 2001/83/EC as a system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. The Agency likewise maintains a pharmacovigilance system to fulfil its pharmacovigilance activities.
Click on the titles below for complete guidelines
Table of contents
I.B.1. Pharmacovigilance
system
I.B.2. Quality, quality
objectives, quality requirements and quality system
I.B.4. Overall quality
objectives for pharmacovigilance
I.B.5. Principles for good
pharmacovigilance practices
I.B.6. Responsibilities for the
quality system within an organisation
I.B.7. Training of personnel
for pharmacovigilance
I.B.8. Facilities and equipment
for pharmacovigilance
I.B.9. Specific quality system
procedures and processes
I.B.9.1. Compliance management
by marketing authorisation holders
I.B.9.2. Compliance management
by competent authorities
I.B.11. Documentation of the
quality system
I.B.11.1. Additional quality
system documentation by marketing authorisation holders
I.B.11.2. Additional quality
system documentation by competent authorities
I.B.11.3. Critical
pharmacovigilance processes and business continuity
I.B.13. Preparedness planning
for pharmacovigilance in public health emergencies
I.C. Operation of the EU
network
I.C.1.2. Qualifications of the
qualified person responsible for pharmacovigilance in the EU
I.C.1.3. Role of the qualified
person responsible for pharmacovigilance in the EU
I.C.1.4. Specific quality
system processes of the marketing authorisation holder in the EU
I.C.2. Overall
pharmacovigilance responsibilities within the EU regulatory network
I.C.2.1. Role of the competent
authorities in Member States
I.C.2.2. Role of the European
Commission
I.C.2.3. Role of the European
Medicines Agency
I.C.2.3.1. General role of the
Agency and the role of the Agency’s secretariat
I.C.2.3.2. Role of the
Pharmacovigilance Risk Assessment Committee (PRAC)
I.C.2.3.3. Role of the
Committee for Medicinal Products for Human Use (CHMP)
I.C.2.6. Transparency of the
quality system of the EU regulatory network
I.C.3. Data protection in the
EU
I.C.4. Preparedness planning in the EU for pharmacovigilance in public health emergencies
EMA GVP Module 1: