Understanding the 6 Important Parts of a Pharmacovigilance System Master File (PSMF)

To market a pharmaceutical drug in the European Union, you must provide a pharmacovigilance system master file (PSMF). In this blog, we explain what that is, why you need it, and what’s included.

Pharmacovigilance System Master File

What Is Pharmacovigilance?

Pharmacovigilance (PV) is the detection, assessment, understanding and prevention of adverse effects from drugs. The goal is to ensure that drugs brought to market are safe for human consumption and don’t cause adverse events.

Regulatory authorities require pharmaceutical companies to prove their drugs are safe by adhering to strict safety standards. Even though all therapies undergo rigorous testing through clinical trials before approval, some side effects may only emerge after being used by a heterogenous population and over a longer period of time. Because of this, pharma companies have to keep track of drug safety over time. To do this, many use PV systems for various functions, from Individual Case Study Reports to risk management planning.

What Is a Pharmacovigilance System Master File (PSMF?)

Now, if your organization currently or plans to market drugs in the European Union (EU), you need to apply for marketing authorization (MA). The regulatory authority for the EU, the European Medicines Agency (EMA), requires all MA applications to include a pharmacovigilance system master file (PSMF).

The PSMF is a document detailing the PV system for the drug. If the EMA asks to see the PSMF after your MA application is approved, you have seven days to provide it or risk losing your MA. Therefore, a PSMF is critical to your organization’s marketing efforts in the EU.

But what goes into a PSMF? Let’s take a look.

The 6 Main Parts of a PSMF

While there is no template for a PSMF, each one must include insights on your:

  1. Qualified person responsible for pharmacovigilance
  2. Organizational structure
  3. Computer system
  4. PV processes
  5. Quality system activities
  6. Delegated activities

1. Qualified Person Responsible for Pharmacovigilance

Your company’s Qualified Person Responsible for Pharmacovigilance (QPPV) is responsible for the safety of the drugs you market in the EU. As part of the MA application, you must designate a QPPV and provide that individual’s resume and standard operating procedures (SOPs). 

Another requirement is to describe the QPPV’s job responsibilities, which are to

  • Set up and maintain a PV system
  • Generate PV reports
  • Respond to requests from competent authorities
  • Provide competent authorities with any other relevant product safety information

2. Organizational Structure

Another component of the PSMF is your company’s organizational structure. The purpose is to show the position of the QQPV in your organization. You will also need to offer a description and write-up for any site that handles pharma data, including safety reports and evaluations.

3. Computer System

As part of your PSMF, you must offer a description of the computer systems that help to collect and report safety information. If you use multiple computer systems or databases, you’ll have to provide a clear overview of how each system applies to PV.

4. PV Processes

Every PV system should have clear processes in place so everyone on the team knows how to handle the PV data compliantly. It should include the following information:

  • A description of the procedural documentation
  • The nature of the field data
  • An indication of how records are held

In addition, there should be an established channel of communication with consumers, healthcare professionals, and competent authorities in case there are safety concerns.

5. Quality System Activities

It’s essential to prove that your PV system is continuously monitored for performance. Examples of quality system activities for PV include:

  • Human resource management
  • Record keeping
  • Performance monitoring

6. Delegated Activities

If your organization uses any subcontractors for PV obligations, you need to describe their activities in the PSMF. This can include:

  • Service providers
  • Commercial arrangements
  • Technical providers

Important Information to Include In Your PSMF

The more information you include in the PV process section of your PSMF, the easier it will be to answer an EMA auditor’s questions. That’s why it’s a best practice to include the following details about changes to anything marketed in the EU:

  • Change information: Details on what was changed in the drug
  • Priority: Whether the drug change is safety or non-safety related
  • Submission due date: When the drug was submitted to the EMA for approval
  • Timeline deviations: Any adjustments to the submission due date and their reasoning
  • Status of submission: Whether the drug was approved or not
  • Outcome of the submission: A final decision on the drug’s approval
  • Key Performance Indicators: A quantifiable measure of performance over time
  • Implementation: When and how the PV system was implemented

With all of this information, you put yourself in a solid position to handle any auditor questions that come your way.


The PSMF is a document that plays a key role in getting your drug marketed in the EU. It encompasses six main sections and additional information that provides the EMA with a clear picture of how your PV system works.

Tracking Portal by Intagras offers PSMF reporting on changes made to marketed items in the EU, the way you like it. Get all the information you need in the format you already use, saving you time, money, and headaches. Contact us to learn more.

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