Veterinary Pharmacovigilance – EU & UK Compliance & Safety Monitoring

Comprehensive pharmacovigilance support for veterinary medicinal products across Europe and the United Kingdom. We help Marketing Authorisation Holders (MAHs) establish and maintain robust veterinary pharmacovigilance systems in line with EU and UK requirements. Our services cover the full spectrum of veterinary drug safety: from setting up Pharmacovigilance System Master Files (PSMFs) and providing Qualified Persons for Pharmacovigilance (QPPVs) for veterinary products, to managing adverse event reporting, signal detection, and compiling periodic safety reports and benefit-risk evaluations. With the changes introduced by Regulation (EU) 2019/6 which repealed Directive 2001/82/EC and became applicable on 28 January 2022 and evolving VMD (UK’s Veterinary Medicines Directorate) guidelines (updated 11 March 2026), veterinary pharmacovigilance has become more rigorous and proactive than ever before. Having a veterinary pharmacovigilance system and a qualified person responsible for pharmacovigilance (QPPV) is a legal obligation for veterinary medicinal product marketing authorisation holders. We ensure your pharmacovigilance system is inspection-ready and fully capable of meeting both EMA and VMD expectations  from timely adverse event reporting and signal management to robust post-market surveillance and continuous benefit-risk assessment, enabling you to protect animal health, comply with all legal obligations, and maintain public trust. Pharmafile PV Services Limited is a pharmacovigilance consultant to the pharmaceutical, veterinary, medical device and healthcare & cosmetic industries.

This service is designed for:

• Veterinary Pharmaceutical Companies (MAHs): Any company that holds marketing authorisations for veterinary medicinal products (e.g. pharmaceuticals, vaccines, medicated premixes for feed, combination or borderline products like certain ectoparasiticides). The MAH should ensure that it has an appropriate system of pharmacovigilance in place in order to assume responsibility and liability for its medicinal products for veterinary use (VMPs) on the market and to ensure that appropriate action may be taken, when necessary. Our support is ideal for small and mid-sized animal health companies without a dedicated pharmacovigilance department, as well as global veterinary divisions of larger pharmaceutical firms that need local EU/UK expertise. We also assist human pharmaceutical companies expanding into animal health, who may need a separate veterinary PV system and specialist oversight to satisfy distinct regulatory requirements.
• Veterinary Biologicals & Feed Additive Producers: Developers and MAHs of products like veterinary vaccines, immunologicals, and medicated feeds or feed additives with health claims. These products often fall under specific or overlapping rules where pharmacovigilance duties exist (e.g. monitoring inefficacy signals for vaccines, feed additive safety issues). We ensure that companies in these niche areas implement appropriate PV processes (for example, capturing lack of efficacy reports for vaccines as required by regulators, or adverse reactions to medicated feed). Signals may also be identified in relation to lack of efficacy or development of resistance. We help navigate the sometimes-grey areas of borderline product regulation such as distinguishing between veterinary medicinal products and other categories (like biocides or feed supplements) and set up proportionate safety monitoring systems as needed.
• Contract Service Providers & Distributors: Companies that partner with MAHs to perform pharmacovigilance tasks or that distribute veterinary products in certain markets. MAHs remain legally responsible for pharmacovigilance, but they often rely on outsourcing (e.g. a contract QPPV or external PV service provider) or delegate certain activities to distributors. We aim to provide a comprehensive tailored-to-suit-individual-companies’-needs vigilance service, including a Qualified Person for Pharmacovigilance (QPPV), and our team is able to undertake whole vigilance requirements or alternatively perform any specific task where a company may have a temporary lack of resource due to increased workload or vacancies. We also support distributors in fulfilling any contractual PV obligations. If someone other than the MAH becomes responsible for the distribution of a veterinary medicine, the MAH must inform the VMD by means of a suitable variation, and suitable pharmacovigilance contracts must be in place to ensure the MAH is informed of any adverse events reported to the distributor.

(If your needs involve human medicines, please see our Pharmacovigilance Services. We have dedicated teams for human and veterinary pharmacovigilance, recognising the regulatory and scientific differences, especially under new veterinary legislation).

Transition to New Veterinary PV Framework: The veterinary pharmacovigilance landscape has undergone fundamental change. In the EU, Regulation (EU) 2019/6 (effective since 28 January 2022) repealed Directive 2001/82/EC, overhauling veterinary pharmacovigilance requirements. Under the new EU rules, with the application of Regulation (EU) 2019/6, the obligation for marketing authorisation holders of veterinary medicinal products to submit PSURs has ceased  this process is replaced by the signal management process. Companies must shift from a reactive, report-based approach to a more proactive model of ongoing data analysis and signal detection. In Great Britain, the VMD requires MAHs to operate a documented signal management process and submit annual Benefit-Risk Reports (BRRs) and prompt Signal Notifications for significant new risks. We ensure that whether you operate in the EU, UK, or both, your pharmacovigilance system meets the latest requirements and can withstand regulatory scrutiny.

Resource & Expertise Gaps in Vet PV: Periodically animal health companies may face internal challenges due to limited pharmacovigilance resources or expertise. Veterinary pharmacovigilance requires specialised knowledge  for example, understanding veterinary-specific clinical terms (VeDDRA terminology for adverse event coding) and managing data on species, breeds, food-producing vs companion animals. It also demands keeping pace with two regulatory regimes (EU and UK) that, while aligned on high-level principles, have differences in reporting portals, submission formats, and timelines. We address these challenges by providing experienced veterinary PV professionals (including EU Qualified Persons for Pharmacovigilance with veterinary expertise, and UK veterinary PV service providers). The QPPV should be appropriately qualified; if the QPPV is not a veterinarian, they should have access to a person qualified in veterinary medicine to assist with technical aspects of adverse event reports, and the assistance should be appropriately documented within the PSMF.

Multi-Source Data Management & Signal Detection: Veterinary safety data come from diverse sources. MAHs should aim to utilise all relevant post-marketing pharmacovigilance data, including: spontaneous reports obtained via direct reporting from all reporters (including those received via sales representatives or other company employees), spontaneous reports obtained as part of an enquiry or product defect concern, spontaneous reports from social media or other media sources, reports from other MAHs, manufacturers or regulatory authorities, reports from routine searches of published literature, post-marketing trials and surveillance studies, new toxicology and international safety data updates, and sales data. Signals may be detected where a sudden increase in the number of adverse events is observed, an increase in the frequency of a particular clinical sign or VeDDRA Preferred Term is recorded, an increasing trend is noted over time, new previously unidentified clinical signs are identified, or a potential impact on public or animal health is suspected. We implement processes and tools to capture all adverse events from every source and establish a signal management process in line with EMA’s veterinary Good Pharmacovigilance Practice (VGVP) guidelines and UK VMD guidelines.

Complex Oversight and Reporting Obligations: Under both EU and UK frameworks, MAHs must produce extensive documentation and fulfil numerous reporting obligations:

• Maintaining a detailed Veterinary Pharmacovigilance System Master File (VPSMF) that accurately describes your PV system.
• Ensuring all individual case safety reports (ICSRs) are collected, collated, and reported within regulatory timelines.
• Preparing new types of aggregate reports: In the EU, standard PSUR submissions have been replaced by continuous signal management processes. In Great Britain, MAHs must submit annual Benefit-Risk Reports (BRRs) and prompt Signal Notifications for significant new risks.
• Handling veterinary-specific inquiries and product defect reports.
• Keeping reference safety information (SPCs and package leaflets) up to date when new safety information emerges.
• The MAH must record and submit the results of this signal management process on an annual basis to the VMD via a Benefit-risk report (BRR) and Signal notifications.

Regulators in the EU and UK require veterinary pharmaceutical companies to operate a pharmacovigilance system that meets rigorous standards:

• A Fully Functional Veterinary PV System with QPPV and PSMF: Having a veterinary pharmacovigilance system and a qualified person responsible for pharmacovigilance (QPPV) is a legal obligation for veterinary medicinal product marketing authorisation holders. The Veterinary Medicinal Products Unit carries out checks and inspections in relation to these legal requirements. Under UK law, the MAH must designate one qualified person responsible for pharmacovigilance (QPPV) for each PSMF it holds, who must be permanently and continuously at the disposal of the MAH. This person is ultimately responsible for all aspects of the pharmacovigilance system. Usually, the QPPV will be designated to a single pharmacovigilance system and respective PSMF; it is acceptable for the same QPPV to provide services for more than one MAH. The MAH must also ensure it has established and maintains one or more pharmacovigilance system master files (PSMF) describing in detail the pharmacovigilance system with respect to its authorised veterinary medicinal products.
• MAH Must Provide QPPV with Adequate Resources: The MAH must ensure that the QPPV can fulfil their responsibilities and activities by providing: appropriate resources including sufficient trained personnel, documented procedures, communication mechanisms including access to all sources of relevant information, authority over and access to the PSMF, and an adequate and effective quality management system for the performance of its pharmacovigilance activities. The MAH must also implement mechanisms to keep the QPPV informed of emerging safety concerns and any other information affecting the evaluation of the benefit-risk balance of their veterinary medicines. The MAH must ensure that the QPPV has the authority to implement changes to the MAH’s pharmacovigilance system and to provide input into the preparation of regulatory action in response to emerging safety concerns.
• Timely Adverse Event Reporting and Comprehensive Data Collection: Authorities expect that all reports of adverse events associated with veterinary products are collected, recorded, and reported in compliance with defined timelines. The MAH must ensure that it has a suitable pharmacovigilance system in place for collecting, collating, and evaluating information in relation to suspected adverse events in respect of any veterinary medicinal product for which it holds an authorisation. The MAH takes responsibility and liability for its veterinary medicinal products on the market and continuously evaluates, by appropriate means, the benefit-risk balance of their veterinary medicinal products (VMPs).
• Proactive Signal Management and Benefit-Risk Assessment: Under the new paradigm, simply collecting and reporting raw data is not enough. Signal management is performed to detect potential safety signals and investigate the possibility of a previously unidentified potential risk, a change in the status of a known risk, or provide reassurance about the absence of a risk of a product or active substance. MAHs should continuously monitor the benefit-risk balance of their VMPs via a documented signal management process, whether the reports derive from the UK or any other country. Both documentation detailing internal signal management processes and evidence that these processes have been followed should be promptly provided to the VMD upon request, whether in relation to an inspection or at any other time. If there is identification of a validated signal suggesting a new risk or change of the benefit-risk balance of the product, or if close monitoring or a post-marketing surveillance study is proposed, the MAH must notify the VMD promptly and within 30 calendar days of it being identified. If an urgent safety signal is identified, the MAH should notify the VMD without delay and no later than the next working day for signals that require restrictions to be implemented, or 3 days where no restrictions are deemed necessary.
• Quality Management System Supporting Pharmacovigilance: The pharmacovigilance system should be supported by a robust and effective quality management system. A QMS is a set of policies, processes, procedures, and records that helps coordinate and direct an organisation’s activities to meet internal and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. An MAH’s QMS should cover organisational structure of the MAH, responsibilities, established processes supported by written procedures, the management of resources for the pharmacovigilance system including sufficient trained personnel, as well as compliance management and record management. The quality management system shall be described in the pharmacovigilance system master file.
• Readiness for Inspection: Inspections may be performed either on site or remotely. If deficiencies are found in the system, they will be mentioned in the inspection report, and the MAH can respond with a CAPA (corrective and preventive action) plan. If major gaps are found in the pharmacovigilance system during the inspection, a re-inspection will be performed. The frequency of inspection for each marketing authorisation holder is based on risk  it could be based on the quality of the reports submitted or the quality of the signal management process. There are several possible types of inspection: a full routine inspection (on-site), a full remote inspection, a PSMF inspection, and a triggered inspection. The legal basis for these inspections is Section 5 of the Veterinary Medicinal Products Regulation (Articles 73 to 81, Articles 123 and 126), with further detail in Implementing Regulation (EU) 2021/1281 and the Implementing Act on Good Pharmacovigilance Practices.

Our delivery model for veterinary pharmacovigilance is comprehensive and flexible, covering system setup, operational support, and continuous compliance management:

Regulatory Framework & Scope (EU/UK Veterinary PV)

We start by aligning your pharmacovigilance system with the current veterinary medicine regulations in your target markets:

• Compliance with EU Regulation 2019/6 & UK VMR: We ensure your PV system meets the detailed requirements of the EU’s veterinary medicinal products regulation (EU 2019/6) which became applicable on 28 January 2022 and repealed Directive 2001/82/EC  and the corresponding UK Veterinary Medicines Regulations (VMR 2013, as amended). The obligations of the MAH for pharmacovigilance associated with their veterinary medicinal products are defined in the VMR 2013 (as amended) Schedule 1 Part 8 paragraph 56. Under the new EU framework, the obligation for marketing authorisation holders to submit PSURs has ceased and is replaced by the signal management process. We update your procedures to reflect this paradigm shift. Additionally, we define the scope of your PV system: which products and territories it covers, and how borderline cases will be handled. This scope definition goes into your PSMF and ensures there is no ambiguity about responsibilities.
• Tailored for Veterinary Nuances: Our approach acknowledges that veterinary pharmacovigilance has unique considerations. We tailor the PV system to account for issues like off-label use in various species, lack of efficacy reporting (signals may also be identified in relation to lack of efficacy or development of resistance), and human safety signals (e.g. accidental self-injection of a veterinary product by a farmer or vet, which is also in scope for vet PV). New information relevant to the signal management process may include the severity, time to onset, duration or outcome of an adverse event, the country in which the event occurred, or clinical information such as gender, age, breed, cause of death or off-label product use. By integrating these veterinary-specific aspects from the outset, we create a PV system that fully meets both European and UK expectations.

We help set up the governance and primary infrastructure of your veterinary PV system:

• Pharmacovigilance System Master File (PSMF): We either compile your Veterinary PSMF from scratch or bring your existing one up to date with current requirements. The MAH must ensure it has established and maintains one or more PSMFs describing in detail the pharmacovigilance system with respect to its authorised veterinary medicinal products. We try to ensure your PSMF includes all elements mandated by EU and UK regulations, and that it remains a living document with change control processes to keep it current as your products, personnel, or processes change. The quality management system shall be described in the pharmacovigilance system master file.
• QPPV and PV Team Support: The MAH must designate one qualified person responsible for pharmacovigilance (QPPV) for each PSMF it holds, who must be permanently and continuously at the disposal of the MAH. We provide experienced EU QPPV services for veterinary products, ensuring you have a named individual who meets all qualifications and can fulfil the role’s responsibilities. The QPPV should be appropriately qualified, with documented experience in all aspects of pharmacovigilance so that they can be responsible for and perform the tasks of the post. If the QPPV is not a veterinarian, they should have access to a person qualified in veterinary medicine to assist with technical aspects of adverse event reports; the assistance should be appropriately documented within the PSMF. The QPPV oversees: the establishment and maintenance of a pharmacovigilance system, preparation of reports for the VMD, the conduct of continuous overall pharmacovigilance evaluation during the post-authorisation period, maintenance of the PSMF and monitoring of the pharmacovigilance system and liaising with the VMD in relation to any pharmacovigilance inspection.
• QPPV Oversight Scope: The QPPV should have oversight of the pharmacovigilance system in terms of structure and performance, including: quality control and assurance procedures, standard operating procedures (SOPs), database operations, contractual arrangements, PSMF preparation and reporting, adverse event reporting, signal management and benefit-risk evaluation, compliance data, post-marketing surveillance studies, communication to stakeholders, deviations and CAPA plan management, audit reports, and pharmacovigilance training of personnel. The role of the QPPV involves extensive tasks depending on the size and nature of the PV system. The QPPV may delegate specific tasks, under supervision, to appropriately qualified and trained individuals; such delegation should be documented in the PSMF. In case of absence of the QPPV, an adequately qualified person must undertake their responsibilities, and the back-up arrangements in place should be described in the PSMF.
• Training & SOPs: We create the necessary Standard Operating Procedures and work instructions for your veterinary pharmacovigilance system (or update existing ones to new standards). The MAH must ensure that it has adequate resources available and that training is provided. We document training completion and can conduct periodic knowledge assessments or internal audits to confirm that processes are being followed.

Our team manages the day-to-day operational tasks of veterinary pharmacovigilance with precision and speed:

• Adverse Event Case Processing: We provide end-to-end handling of Individual Case Safety Reports (ICSRs) for veterinary products. This includes triaging incoming adverse event reports (from vets, farmers, pet owners, literature, or your product distributors), performing case intake, coding clinical signs using VeDDRA terminology (the veterinary adverse event dictionary, referenced as VeDDRA Preferred Terms), and writing high-quality case narratives. We can help in this area from adverse reaction case processing, answering veterinary enquiries into the product usage (veterinary information), understanding the varied legislation, providing aggregate data assessments (safety reviews), helping to keep labelling up to date, and literature searching for possible adverse reactions.
• Signal Detection & Management: We implement a structured signal management process tailored to your product portfolio and data volume. The signal management process is a process for performing active surveillance of pharmacovigilance data for VMPs and active substances, assessing that data, and determining whether there is any change to the benefit-risk balance of those products or active substances. The process should include signal detection and analysis, validation, prioritisation, assessment and confirmation, and subsequent recommendation of proposals for action if required. At a minimum, the process should be able to identify: a sudden and unexpected increase in the number of adverse events, an unexpected increase in the frequency of a known clinical sign, a new clinical sign, and reports in scientific literature of any of the above.
• For smaller MAHs with lower case volume, this might involve scheduled qualitative reviews of cumulative data by our veterinary safety experts. For larger portfolios generating significant data, we incorporate quantitative methods. When a large number of adverse event reports are received or multiple data sources are integrated, it is recommended to use statistical methods and data mining algorithms based on 2×2 contingency tables producing disproportionality analysis. Frequently used measures of association include proportional reporting ratio (PRR), reporting odds ratio (ROR), relative reporting ratio (RRR), and information coefficient (IC). MAHs should continuously monitor their products as part of their signal management process, in a risk-based manner, for instance a monthly review of the number of new cases received and the number of animals reacted could be performed to ensure early detection of potential signals. MAHs should be able to provide evidence of continuous monitoring on request or at time of inspection. Sales fluctuations and seasonal patterns should be taken into consideration when analysing these numbers.

When a signal is confirmed, we draft prompt Signal Notifications to inform authorities. If there is identification of a validated signal suggesting a new risk or change of the benefit-risk balance of the product, the MAH must notify the VMD promptly and within 30 calendar days. If an urgent safety signal is identified, the MAH should notify the VMD without delay and no later than the next working day for signals that require restrictions to be implemented, or 3 days where no restrictions are deemed necessary. Any additional validated signals that do not suggest a new risk or change to the benefit-risk balance should be submitted as part of the annual Benefit-Risk Summary Report.

• Data Management & Regulatory Submission: We maintain a validated pharmacovigilance database for veterinary AE data. We perform regular data reconciliations to ensure completeness. Multiple spontaneous adverse event reports are usually required for the threshold to be met for a signal; if a single report contains detailed information regarding an adverse event of significant seriousness or severity and/or involved multiple animals, it may be considered to meet the threshold, but this would only be applicable in very rare and specific circumstances. Our approach aims for first-time-right submissions meaning information is complete and correctly formatted so that regulators can easily process it.

Although routine Periodic Safety Update Reports (PSURs) for veterinary medicines have been phased out in the EU  with the application of Regulation (EU) 2019/6 from 28 January 2022, the obligation for marketing authorisation holders of veterinary medicinal products to submit PSURs has ceased veterinary pharmacovigilance still requires periodic analysis of safety data and structured reporting in various forms:

• Periodic Benefit-Risk Assessments: In Great Britain, MAHs must compile Benefit-Risk Reports (BRRs) for each product or product family on an annual basis, summarising the outcomes of their signal management and the current benefit-risk balance. The MAH must record and submit the results of this signal management process on an annual basis to the VMD via a Benefit-risk report (BRR) and Signal notifications. In the EU, while traditional PSUR submissions have ceased and are replaced by the signal management process, MAHs need to perform continuous benefit-risk monitoring and be ready to provide summary reports or respond to safety queries by the EMA or national agencies on request. We use these analyses to update your product’s reference safety information (e.g. adding new adverse events or warnings to the SPC/package leaflet) and to feed back into your risk management measures.
• Vigilance in Product Lifecycle Management: We integrate pharmacovigilance considerations into your product’s regulatory lifecycle. When you’re preparing a variation or a renewal of a veterinary MA, we ensure the variation dossier includes all required PV documentation. If an MAH acquires a Marketing Authorisation (MA) for a veterinary medicine from another MAH, it should be ensured that the previous MAH provides all available pharmacovigilance information relating to the medicine, including any available sales data; the transfer of pharmacovigilance activities and data should be outlined in an appropriate pharmacovigilance agreement. By embedding PV expertise into regulatory affairs and business decisions, we help you avoid gaps during product license transfers or acquisitions.
• Veterinary Product Safety Communications: Part of lifecycle pharmacovigilance involves communicating new safety findings to stakeholders. Where the signal management process identifies the necessity for a variation in an authorisation, the MAH must also promptly submit an application for such a variation. We assist in drafting and distributing safety communications to veterinarians, farmers, or pet owners if required, and ensure that any changes needed to product labelling are supported by evidence and submitted as regulatory variations promptly

We prepare your veterinary pharmacovigilance system to avoid typical pitfalls and respond effectively to regulatory audits:

• Pharmacovigilance System Master File Issues: A recurring inspection finding is that the PSMF is incomplete, outdated, or not reflective of reality. We routinely audit and update your PSMF to ensure it accurately describes your system at all times and implement PSMF maintenance procedures (e.g. version control and QPPV approval for each change). The MAH should maintain high level organisation charts providing an overview of the pharmacovigilance units and organisations and illustrating the relationships between them, showing the main reporting relationships with management and clearly showing the position of the QPPV within the organisation. If the tasks of the QPPV are outsourced to a third party, those arrangements should be described in the PSMF and included in a service agreement.
• Inadequate QPPV Oversight & Resources: Regulators frequently cite companies if the QPPV is a figurehead without real authority or resources. We help you avoid this by ensuring the QPPV is properly embedded in your processes. The MAH must provide the QPPV with appropriate resources including sufficient trained personnel, documented procedures, communication mechanisms including access to all sources of relevant information, authority over and access to the PSMF, and an adequate and effective quality management system. We also document backup QPPV arrangements (deputy QPPV), since inspectors will check that continuity plan in case of absence of the QPPV, an adequately qualified person must undertake their responsibilities, and the back-up arrangements should be described in the PSMF.
• Insufficient Signal Documentation: As veterinary pharmacovigilance moves towards continuous signal management, inspectors now expect to see evidence that you are performing signal detection and documenting it. Both documentation detailing internal signal management processes and evidence that these processes have been followed should be promptly provided to the VMD upon request, whether in relation to an inspection or at any other time. We institute a schedule (e.g. signal review meetings, depending on data volume) and maintain records of those reviews. Signal prioritisation should be carried out throughout the signal management process, with requirements split into two stages (Stage 1 as an initial sift and Stage 2 a further sift of those signals already prioritised). Additional monitoring is required for products in certain high-risk groupings.
• Contractual Gaps and Global PV Integration: We help put in place pharmacovigilance agreements with all relevant third parties. If someone other than the MAH becomes responsible for the distribution of a veterinary medicine, the MAH must inform the VMD by means of a suitable variation, and suitable pharmacovigilance contracts must be in place to ensure the MAH is informed of any adverse events reported to the distributor. The MAH is also obliged to inform the VMD of any valid signal identified by any regulatory authority in any country where the product is marketed which might influence the evaluation of the benefit-risk balance of the product concerned.
• Business Continuity: The MAH should assess risks with potential impact on the pharmacovigilance system and plan for business contingency, including back-up procedures to cover, for example, non-availability of personnel, adverse event database failure, or failure of other hardware or software with impact on electronic reporting and data analysis.

Our veterinary pharmacovigilance services are designed to meet the requirements of both European Union and United Kingdom regulators:

• European Union (EEA): We support compliance with EU veterinary pharmacovigilance regulations, primarily Regulation (EU) 2019/6 and its implementing acts, which apply across all EU member states (and through the EEA). Section 5 of the Veterinary Medicinal Products Regulation (Articles 73 to 81, Articles 123 and 126) describes the rules relating to the monitoring of veterinary medicines, with further detail in Implementing Regulation (EU) 2021/1281 and the Implementing Act on Good Pharmacovigilance Practices. Articles 123 and 126 of the Regulation and Sections 26 and 27 of the Implementing Act on Good Pharmacovigilance Practices set out the legal basis for inspections and checks relating to veterinary pharmacovigilance. This Regulation has completely changed the rules relating to veterinary pharmacovigilance, and it is expected that the procedures will be clarified further over the next few years as guidance documents are supplemented or amended. We ensure your PV system meets the latest guidance from the Committee for Medicinal Products for Veterinary Use (CVMP) and EMA’s Veterinary Good Pharmacovigilance Practices (VGVP) guidelines.
• United Kingdom: We cover Great Britain (England, Scotland, Wales) and Northern Ireland pharmacovigilance obligations. In Great Britain, we align your system with the Veterinary Medicines Regulations (VMR) 2013 (as amended) and VMD’s Guidance on Pharmacovigilance in GB (guidelines updated 11 March 2026, applying to England, Scotland and Wales). The obligations of the MAH for pharmacovigilance associated with their veterinary medicinal products are defined in the VMR 2013 (as amended) Schedule 1 Part 8 paragraph 56, and the obligations of the QPPV are defined in Schedule 1 Part 8 paragraph 56B. We handle GB-specific processes  setting up and maintaining a GB PSMF, appointing a UK QPPV, and using the VMD’s services to submit adverse events and annual Benefit-Risk Reports. For Northern Ireland, EU rules still apply, so our EU-aligned service covers NI needs, and we manage any dual-reporting requirements.
• Global Alignment: While our main focus is EU and UK, our veterinary pharmacovigilance practices follow the principles of international standards. We can support harmonisation of pharmacovigilance across different regions. In all cases, we emphasise synergy using data gathered in one region to inform global safety assessments and actions, and vice versa.

Veterinary pharmacovigilance activities follow regulatory timelines with some nuances. Below are typical timelines and schedules:

These timelines are guidelines. Veterinary PV is by nature unpredictable (e.g. a surge of adverse events might occur if there is an issue with a batch of vaccine on the market). Our team is structured to handle such surprises: we have on-call QPPV availability and surge capacity to process increased caseloads on short notice. We work with you to define realistic timelines that comply with all regulatory deadlines and ensure animal safety.

By leveraging our expertise, we help your company avoid common veterinary pharmacovigilance pitfalls:

• Underestimating the New PV Requirements: Some MAHs assume that veterinary PV is “lighter” or can simply mirror human pharmacovigilance. A notable mistake is failing to adapt to the post-2019/6 regime: for example, continuing to compile PSURs without implementing a modern signal management procedure. With the application of Regulation (EU) 2019/6, the obligation for marketing authorisation holders to submit PSURs has ceased and is replaced by the signal management process. We keep you updated on regulatory changes and ensure your processes and mindsets shift with them.
• Incomplete Adverse Event Capture (Especially via Third Parties): We often find that MAHs have gaps in collecting AE reports, particularly from distributors or partners. MAHs should aim to utilise all relevant post-marketing pharmacovigilance data which they could reasonably be expected to be aware of, including spontaneous reports obtained via direct reporting from all reporters, including those received via sales representatives or other company employees, reports from social media or other media sources, and reports from routine searches of published literature. We implement comprehensive intake processes: training external partners and commercial teams to forward any safety information promptly, monitoring scientific literature and online sources as needed, and reconciling with customer service logs.
• Neglecting the Quality System Around PV: Another frequent issue is treating PV as a standalone activity divorced from the company’s quality management. The pharmacovigilance system should be supported by a robust and effective quality management system covering organisational structure of the MAH, responsibilities, established processes supported by written procedures, the management of resources including sufficient trained personnel, as well as compliance management and record management. While there must be compliance with the legal requirements, the implementation of a quality system should be adapted to the respective organisation. We integrate veterinary PV into your global QMS or establish a fit-for-purpose QMS, with documentation tailored to veterinary needs.
• Overlooking Local and Global PV Coordination: Many veterinary product companies operate internationally, and a common mistake is failing to have a unified view of safety data. The MAH is obliged to inform the VMD of any valid signal identified by any regulatory authority in any country where the product is marketed which might influence the evaluation of the benefit-risk balance of the product concerned. We close these gaps by establishing clear global PV workflows and managing pharmacovigilance agreements to guarantee that responsibilities are clear and there are no blind spots.
• Insufficient Preparedness for Regulatory Scrutiny: A pervasive mistake is not being inspection-ready at all times. The frequency of inspection for each marketing authorisation holder is based on risk  it could be based on the quality of the reports submitted or the quality of the signal management process. Companies that treat PV as a low priority scramble when inspection notification arrives. We instil a culture of continuous inspection readiness, maintaining inspection files containing all key evidence so they can be produced at short notice.
• Misjudging Reporting Obligations for Borderline Cases: We often find confusion about what constitutes a reportable event. For example, lack of expected efficacy in an antimicrobial might be a reportable event under pharmacovigilance, not just a product quality complaint. Signals may be identified in relation to lack of efficacy or development of resistance. Similarly, any human adverse reaction to a veterinary product must be treated with appropriate seriousness. By treating these borderline cases appropriately, you avoid under-reporting important safety information to regulators.

Veterinary pharmacovigilance intersects with various other regulatory and safety domains. We ensure our services are well-coordinated with your other obligations and with our other offerings:

• Veterinary Regulatory Affairs: Effective pharmacovigilance relies on accurate and up-to-date regulatory information. Our Veterinary Regulatory Affairs team works closely with PV for example, when a safety signal necessitates a product information update or when preparing the pharmacovigilance sections of a new marketing authorisation.
• Human Pharmacovigilance: Some companies operate combined human and veterinary portfolios. Our Pharmacovigilance Services (for human medicines) and Veterinary Pharmacovigilance services are managed by distinct but collaborative teams. Pharmafile PV Services Limited is a pharmacovigilance consultant to the pharmaceutical, veterinary, medical device and healthcare & cosmetic industries. This ensures that insights relevant across domains are shared for a holistic risk assessment.
• Cosmetovigilance & Device Vigilance: If your company also deals with veterinary-adjacent products, we provide vigilance services in those areas too. Our services navigation includes Cosmetovigilance, Herbal Vigilance, Medical Device Vigilance, Medical Information, Nutraceuticals, QPPV Services, Pharmacovigilance, and Veterinary Pharmacovigilance.
• Quality Defect Management: Sometimes product quality issues can lead to adverse events in animals. Our Quality Services team coordinates with PV in such cases managing any recall or field safety corrective action while PV reports the adverse events and assesses the incident’s impact on product safety profile.
• Training & Compliance Consulting: Beyond operational support, we offer training workshops for your staff on veterinary pharmacovigilance and audit support if you need to evaluate partners.