PV Bulletin

New digital service for MAHs to report safety data

The Veterinary Medicines Directorate (VMD) launched a new digital service for Marketing Authorisation Holders (MAHs) to submit pharmacovigilance reports, streamlining the submission process.

Primary source: Veterinary Medicines Directorate (VMD)

PV Impact Brief

Urgency: HighConfidence: high

What changed

The launch of the new VMD Industry Pharmacovigilance Reporting Service effective from July 10, 2026, allows MAHs to submit safety data through a centralized digital platform, integrating multiple submission types.

Why it matters

This new service enhances the efficiency and user-friendliness of reporting obligations, helping MAHs comply with legislative requirements.

Action needed

MAHs are encouraged to transition to the new digital service for all pharmacovigilance reporting and utilize the feedback function during the beta phase to improve the service.

Relevant for
Regulatory Intelligence LeadSignal Management LeadQPPV
Processes impacted
ICSRSignal ManagementCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review before 2026-07-10.

Policy change details

Document type
Notice
Policy status
effective
Publication date
2026-07-10
Effective date
2026-07-10
Policy change
The Veterinary Medicines Directorate (VMD) has launched a new digital service for Marketing Authorisation Holders (MAHs) to submit pharmacovigilance reports. This service centralizes various submission types, including Benefit-Risk Submission Reports, signal notifications, and XML reports, into a single platform.

Key changes

Launch of the VMD Industry Pharmacovigilance Reporting Service. It supports submission of Benefit-Risk reports, signal notifications, Pharmacovigilance Sales Submissions, and XML reports. Features include submission status tracking and exportable logs. It is currently in beta but available for use.

Affected workflows

ICSRSignal ManagementCountry Compliance

Responsible groups

Pharmacovigilance OperationsIT/SystemsQPPV

PV impact

MAHs for veterinary medicines should transition to the new digital service for submitting safety data and signal notifications. While optional during the beta phase, it is designed to replace the VMDS secure messaging service over time.

View regulator source

Source document details

Exact policy details

Launch Date of New Digital Service for MAHs
10 July 2026
Applies to: Marketing Authorisation Holders (MAHs) of animal medicines
A new digital service for Marketing Authorisation Holders (MAHs) of animal medicines to submit pharmacovigilance reports to the Veterinary Medicines Directorate (VMD) went live on 10 July 2026. · p. 1 · High · Source
Launch Date of Adverse Event Reporting Service
20 May 2026
Applies to: Animal owners, veterinary professionals, and Suitably Qualified Persons
This follows the launch of our Adverse Event Reporting Service for use by animal owners, veterinary professionals and Suitably Qualified Persons on 20 May 2026. · p. 1 · High · Source

Workflow rule impacts

Country Compliance | ICSR | Signal ManagementMarketing Authorisation Holders (MAHs)

More efficient and user-friendly experience for MAHs

Integration of multiple submission types into a single platform

The service has been designed to make it easier for MAHs to fulfil their legislative requirements, offering a more efficient and user-friendly experience than previous reporting routes. · p. 1 · High · Source
Country ComplianceMarketing Authorisation Holders (MAHs)

MAHs can choose whether to adopt new reporting system or continue with existing methods

Optional use of new digital service during beta version

The service is being released as an optional beta version, and MAHs are encouraged to use the feedback function within the service to share their experience. · p. 1 · High · Source

Evidence and confidence

Confidence: highSource updated: Jul 10, 2026

Full briefing

Practical implication

MAHs are encouraged to transition to the new digital service for all pharmacovigilance reporting and utilize the feedback function during the beta phase to improve the service.

The VMD has introduced a new digital service that centralizes various pharmacovigilance report submissions for MAHs, including Benefit-Risk Submission Reports and signal notifications, into a single platform. This service is currently in beta and will replace the VMDS secure messaging service over time.

What changed: The launch of the new VMD Industry Pharmacovigilance Reporting Service effective from July 10, 2026, allows MAHs to submit safety data through a centralized digital platform, integrating multiple submission types.

Why it matters: This new service enhances the efficiency and user-friendliness of reporting obligations, helping MAHs comply with legislative requirements.

Practical implication: MAHs are encouraged to transition to the new digital service for all pharmacovigilance reporting and utilize the feedback function during the beta phase to improve the service.

View original source

Published from the Firecrawl policy change extraction pipeline.

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