2026 Shift - Is Your PV System Ready for the Change?

The rules for pharmacovigilance (PV) outsourcing are changing. So at PDS we are asking you, is your PV System ready for the change?

On 12 February 2026, the EU’s new Regulation (2025/1466) officially takes effect, marking the biggest update to vendor oversight in over a decade.

What’s changing for you?

In short: The days of vague vendor contracts are over. Regulators are demanding total transparency. As a Marketing Authorisation Holder (MAH), you remain 100% responsible for your PV activities, even if you outsource them.

Key things you need to know:

No Hidden Subcontracting: Your vendors can’t pass work to another company without your written permission.

Audit-Ready, Always: Third-party providers must now agree to direct inspections and audits.

Risk-Based Focus: You’ll need a documented plan to monitor your vendors based on the risk they pose to your system.

PSMF Updates: You only need to track major or critical gaps now, but the accuracy of your vendor list is now more important than ever.

Where do we in the UK stand?

Currently, the MHRA has not mirrored these changes. For now, this is an EU-specific update, but it’s a high bar that most global companies will wish to meet regardless.

The new standards of oversight:

Contractual Precision: Agreements must now explicitly define data exchange, audit rights, and prohibitun authorised subcontracting.

Direct Accountability: Regulators now have the power to inspect your third-party providers directly.

Proactive Monitoring: MAHs must demonstrate a risk-based oversight model, including regular performance monitoring and CAPA follow-ups.

The Bottom Line: Outsourcing is still a vital tool, but it no longer transfers responsibility. You must retain full visibility and control over every link in your PV chain.

The PDS difference

We do not just provide services; we provide solutions that make sense. While the UK(MHRA) hasn’t yet mirrored the rule, we are preparing our partners for these global changes.

How we can support you today:

PV System Gap Analysis: We’ll look at your current set up and identify exactly what needs to be changed.

PSMF Health Checks: Ensuring your documentation is accurate, transparent, and inspection ready.

Expert Vendor Auditing: Our qualified auditors are ready to conduct the risk-based audits the new regulations require.

Contact our Team at PDS today; don’t wait until it’s too late, we are here to help.  

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