Primary source: Veterinary Medicines Directorate (VMD)
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.
This new service enhances the efficiency and user-friendliness of reporting obligations, helping MAHs comply with legislative requirements.
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.
Regulatory Intelligence Lead
Review before 2026-07-10.
Retirement of legacy PV reporting systems; launch of a new unified digital portal; mandatory digital submission for PSURs/PBRERs and adverse events.
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.
The process for submitting pharmacovigilance reports will shift to a new digital platform.
Transition to digital submission
Streamlined visualization and selection of product groups and related product information.
Use of built-in product dictionary
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.
Published from the Firecrawl policy change extraction pipeline.
Implement a gap analysis for 505(b)(2) applications to identify safety data needs and adjust safety monitoring systems as necessary to accommodate new product characteristics.
Clinical investigations must now include justification for DDM selection and ensure that DHTs are verified and validated to support their intended clinical role.
Ensure compliance checks are reinforced in the inspection readiness processes to account for potential non-compliance surrounding product imports.
Developers of MBMPs must align their safety assessment protocols with the MHRA's expectations and are encouraged to engage with the MHRA early to establish appropriate regulatory strategies.
