EMA GVP Module 2


Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file (Rev 2):

Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file (Rev 2):


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.

Click on the titles below for complete guidelines

Table of contents

II.A. Introduction

II.B. Structures and processes 

II.B.1. Objectives

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.4.8. Annex to the PSMF 

II.B.5 Change control, logbook, versions and archiving

II.B.6. Pharmacovigilance system master file presentation

II.B.6.1. Format and layout

II.C. Operation of the EU network 

II.C.1. Responsibilities

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

II.C.3. Transparency

EMA GVP Module 2:


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