Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file (Rev 2):
Introduction:
The legal requirement for marketing authorisation holders to maintain and make available upon request a pharmacovigilance system master file (PSMF) was introduced by Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC (see Recitals (7) and (35), Article 23(4), Article 104(3)(b) of Directive 2010/84/EU) and Regulation (EU) No 1235/2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 (see Recitals (22) and (25), Article 16(3a) of Regulation (EU) No 1235/2010), to harmonise and strengthen the conduct of pharmacovigilance activities in the EU.
The PSMF definition is provided in Article 1(28e) of Directive 2001/83/EC and the minimum requirements for its content and maintenance are set out in the Commission Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC. The detailed requirements provided by the Commission Implementing Regulation are further supported by the guidance in this GVP Module.
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Table of contents
II.B. Structures and processes
II.B.2. Registration and maintenance
II.B.2.1. Summary of the applicant’s pharmacovigilance system
II.B.2.2. Location, registration and maintenance
II.B.2.3. Transfers of responsibilities for the pharmacovigilance system master file
II.B.3. The representation of pharmacovigilance systems
II.B.4. Information to be contained in the pharmacovigilance system master file
II.B.4.1. PSMF section on qualified person responsible for pharmacovigilance (QPPV)
II.B.4.2. PSMF section on the organisational structure of the marketing authorisation holder
II.B.4.3. PSMF section on the sources of safety data
II.B.4.4. PSMF section on computerised systems and databases
II.B.4.5. PSMF section on pharmacovigilance processes
II.B.4.6. PSMF section on pharmacovigilance system performance
II.B.4.7. PSMF section on quality system
II.B.5 Change control, logbook, versions and archiving
II.B.6. Pharmacovigilance system master file presentation
II.C. Operation of the EU network
II.C.1.1. Marketing authorisation holders and applicants
II.C.1.2. National competent authorities
II.C.1.3. The European Medicines Agency
II.C.2. Accessibility of the pharmacovigilance system master file
EMA GVP Module 2:
