Pharmacovigilance System Master File
Pharmacovigilance System Master File (PSMF) is a key document required by legislation that you need to develop and routinely maintain to be able to provide an overview of your overall pharmacovigilance system in cases of inspection.
How can we develop it for you?
There is no great magic behind putting a PSMF together, the magic is in what it describes. If you need to set up a new pharmacovigilance system, it’s easiest to turn to us. PSMF will then already be prepared for you thanks to our ready-made PSMF template describing our global end-to-end PV system.
We’ll just need to work with you on filling in couple of blank spaces like your internal quality system, org. structure, medical information, licensees & other partners, and a few other areas.
When do you need a PSMF?
If you’re planning on placing your first medicinal product on the market, then you should have a PV system in place at the time of submitting your Marketing Authorization Application (MAA). And as you already know, the PSMF is an overview of that system so it should be developed when you’re submitting the MAA.
For your actual MA application, you will need a Summary of Pharmacovigilance System that shall include the PSMF number, PSMF location, and details about your Qualified Person for Pharmacovigilance.
Where do you need one?
Most notably, a PSMF has been a requirement from the European legislators, so if you’re present in at least one European market, you need to keep a pharmacovigilaance system master file.
Furthermore, you may need to maintain local PSMFs in several countries, for example France, Saudi Arabia, or newly United Kingdom, among other countries around the world.
UK PSMF is a new requirement after Brexit and part of our global service. Have a look at what we can do for you in the United Kingdom and how to navigate the MHRA pharmacovigilance requirements.
And how do we make sure to keep this up to date?
In Tepsivo PV system, EU QPPVs simply log into our proprietary Tepsivo Platform and see everything for themselves, with the ability to comment directly on any given activity as they see fit.
The legal requirement of access to PSMF as well as oversight of all PV tasks is guaranteed at all times. Tens of admin hours saved each month, and an EU QPPV happier, more effective, and focused on what should matter and what they are trained for.
Read more about our global end-to-end pharmacovigilance system
and how we manage this via our unique Tepsivo Platform.
Reach out to us and we can showcase to you how using our PSMF template, following precisely the required PSMF guidelines. We can start with a PSMF sample and take it from there.
Let’s have a chat
Whatever your needs are, we look forward to getting in touch with you.
Feel free to drop us a message and we will contact you right away.
Tepsivo Oy | Urho Kekkosen katu, 4-6 E, 00 100, Helsinki, Finland | VAT number FI31367614 | [email protected] | +358 402 204 698 | Privacy policy
