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II.B.4. Information to be contained in the PSMF/ PSSF No.PSMF/ PSSF sectionRemarksCover Page: 1 The unique number (Revision No.) 2 The name of the MAH, QPPV or LSR (including third party). 3 The name.

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The Pharmacovigilance System Master File describes the MAH's pharmacovigilance system and documents the compliance with the legal requirements in the EU/EEA. The PSMF provides a detailed description of all pharmacovigilance activities performed by the MAH in order to ensure safety of its products.

A robust pharmacovigilance (PV) system consists of a safety database, Standard Operating Procedures (SOPs), a network of trained qualified persons in different regions, working with local regulators in local languages, and with regional regulators EMA, FDA, or MHRA.

A Pharmacovigilance System Master File (PSMF) is a comprehensive document containing the detailed description of a Marketing Authorization Holders' (MAH's) pharmacovigilance (PV) system ensuring the safety of their products.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.

The purpose of the PSMF is first to provide the QPPV with a constantly updated oversight of the Pharmacovigilance System and in addition to ensure that all regulatory and company requirements are met.

The PSMF provides an overview of the pharmacovigilance system, which may be requested and assessed by national competent authorities during marketing authorisation application(s) or post-authorisation.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232