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 LeadQPPV
Processes impacted
ICSRCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review before 2026-07-10.

Policy change details

Document type
News / Procedural Update
Policy status
Effective
Publication date
2026-07-21
Effective date
2026-07-21
Policy change
The VMD has launched a new digital portal for the submission of animal medicine safety data, including Periodic Safety Update Reports (PSURs) and adverse event reports. This new service replaces old submission methods and aims to improve data quality and streamline regulatory oversight.

Key changes

Retirement of legacy PV reporting systems; launch of a new unified digital portal; mandatory digital submission for PSURs/PBRERs and adverse events.

Affected workflows

ICSRCountry Compliance

Responsible groups

PV OperationsIT / Safety Systems

PV impact

MAHs for veterinary medicines in the UK must transition to the new VMD portal for all safety reporting activities. The system introduces enhanced validation checks, requiring PV teams to ensure data accuracy before submission.

View regulator source

Source document details

Exact policy details

Launch Date of New Digital Service
10 July 2026
Applies to: All Marketing Authorisation Holders (MAHs) for 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
Types of Submissions Supported
Benefit-Risk Submission Reports, Pharmacovigilance Sales Submissions, dose factor justifications, signal notifications, XML reports
Applies to: All pharmacovigilance report submissions by MAHs
The VMD Industry Pharmacovigilance Reporting Service brings together a range of submission types into a single platform, including Benefit-Risk Submission Reports, Pharmacovigilance Sales Submissions, dose factor justifications, signal notifications and XML reports. · p. 1 · High · Source

Workflow rule impacts

ICSRMarketing Authorisation Holders (MAHs)

The process for submitting pharmacovigilance reports will shift to a new digital platform.

Transition to digital submission

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
Signal ManagementMarketing Authorisation Holders (MAHs)

Streamlined visualization and selection of product groups and related product information.

Use of built-in product dictionary

A built-in product dictionary allows straightforward visualisation and selection of product groups and related product information. · 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.

Related updates for your role

publicFDA · USA · Updated Sep 4, 2026

FDA Grants Accelerated Approval to Etcamah for Advanced Breast Cancer

Urgency: High

Regulatory teams must prepare for updating labeling to include details on the new indication and required diagnostic methods, along with planning for the confirmatory studies mandated by the FDA.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 4, 2026

Change to the definition of regulated activity with children from 1 September 2026

Urgency: High

Organizations must re-evaluate roles related to children's activities and prepare to request Enhanced DBS checks including access to the Children’s Barred List check starting from 1 September 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of Gore Viabahn Endoprosthesis with Bioactive Heparin Coating

Urgency: High

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Atellica CH Revised C-Reactive Protein (RCRP) Safety Information - Siemens Healthcare Diagnostics

Urgency: High

Laboratories must implement the safety measures as indicated by the action registration number R2625739, effective from the notice date of September 7, 2026.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward