FOI release

FOI2026/01051 - Annual information on Librela and Solensia

Published 23 September 2026

1. Your request

Under the Freedom of Information Act 2000, I request the following information relating to the veterinary medicinal products:

  *   Librela
  *   Solensia

For each product separately, please provide annual information for each complete calendar year (January 1 to December 31) from the year of first UK authorisation to the most recent year for which records are available.

1.1 Marketing Authorisation and Regulatory Fees

Please provide the annual amounts paid to the VMD in relation to:

  *   New Full Marketing Authorisation applications.
  *   Pre-approval fees.
  *   New Active Substance fees.
  *   Animal Test Certificate (ATC) fees.
  *   Any fees associated with scientific advice.
  *   Any fees associated with accelerated assessment procedures.
  *   Any fees associated with data exclusivity or regulatory protection applications.
  *   Any other application, assessment or authorisation fees not listed above.

1.2 Post-Authorisation Fees

Please provide annual amounts paid to the VMD for:

  *   Variations to Marketing Authorisations.
  *   Renewals or re-authorisations.
  *   Annual maintenance fees.
  *   Pharmacovigilance-related fees.
  *   Referral procedures.
  *   Any post-authorisation assessment fees.
  *   Any other post-authorisation regulatory fees.

1.3 Inspection Activities and Costs

For each calendar year, please provide:

  *   The number of inspections undertaken relating to facilities manufacturing, testing, batch releasing, importing, exporting, distributing, wholesaling, or otherwise involved with Librela or Solensia.
  *   The date of each inspection.
  *   The country in which the inspected facility was located.
  *   Whether the inspection was pre-authorisation, routine, for-cause, pharmacovigilance-related, GMP, GDP, or another inspection category.
  *   The direct inspection fee charged.
  *   Travel costs charged.
  *   Accommodation costs charged.
  *   Subsistence costs charged.
  *   Any other inspection-related costs recovered by the VMD.
  *   The total amount invoiced or recovered for each inspection.
  *   Whether any deficiencies, major findings, critical findings, or enforcement actions resulted.

1.4 Revenue Received by the VMD

Please provide annual revenue received by the VMD relating to Librela and Solensia from:

  *   Marketing authorisation fees.
  *   Annual maintenance fees.
  *   Variation fees.
  *   Inspection fees.
  *   Pharmacovigilance fees.
  *   Any other fees or charges.

Please provide totals by category and overall totals.

1.5 Royalties, Sales-Based Payments or Revenue Sharing

Please confirm whether the VMD, the Secretary of State, or any UK government body has received:

  *   Royalties.
  *   Revenue-sharing payments.
  *   Sales-based payments.
  *   Percentage-of-sales payments.
  *   Licensing income.
  *   Intellectual property income.

Relating to Librela or Solensia.
If such payments exist, please provide:

  *   The legal basis for the payments.
  *   The recipient organisation.
  *   The annual amount received.
  *   The calculation methodology.
  *   Copies of relevant agreements where disclosure is permitted.

1.6 Pharmacovigilance and Safety Review Activity

For each calendar year, please provide:

  *   Number of adverse event reports received concerning Librela.
  *   Number of adverse event reports received concerning Solensia.
  *   Number of serious adverse event reports.
  *   Number of fatal adverse event reports.
  *   Number of periodic safety reviews conducted.
  *   Number of signal assessments conducted.
  *   Number of safety-related referrals, investigations or escalations.
If annual figures have already been published, please provide links or references.

1.7 External Experts and Committees

For each year, please provide:

  *   Any payments made to external experts, consultants, advisory groups or committee members specifically relating to the assessment, authorisation, monitoring or review of Librela or Solensia.
  *   The purpose of those payments.
  *   Any payments made to Zoetis, Zoetis staff or Zoetis consultants.
  *   The amount paid.

1.8 Enforcement and Compliance

For each year, please provide:

  *   Any warning letters, deficiency notices, compliance actions or enforcement actions issued relating to facilities manufacturing, distributing or monitoring Librela or Solensia.
  *   The nature of the issue identified.
  *   The outcome.

1.9 Manufacturer-Specific Revenue

For each calendar year, please provide:

  *   The total amount of fees and charges paid to the VMD by Zoetis.
  *   A breakdown of those fees by category, including but not limited to:
     *   Marketing authorisation fees.
     *   Variation fees.
     *   Renewal fees.
     *   Annual maintenance fees.
     *   Inspection fees.
     *   Pharmacovigilance fees.
     *   Scientific advice fees.
     *   Any other regulatory fees.
  *   The percentage of the VMD’s total annual fee income represented by payments from Zoetis.
  *   The percentage of the VMD’s total annual operating income represented by payments from Zoetis.
  *   Any analysis, reports, or internal assessments held by the VMD regarding reliance on fee income from Zoetis.

1.10 Meetings, Correspondence and Potential Conflicts of Interest

For each calendar year, please provide:

A. Meetings and Communications

  *   The number of meetings between VMD officials and representatives of Zoetis concerning Librela or Solensia.
  *   The dates of those meetings.
  *   The purpose or subject matter of each meeting.
  *   Copies of meeting minutes, agendas, briefing notes, presentations, records of discussion, and follow-up actions where disclosure is permitted.
  *   Copies of correspondence between the VMD and Zoetis relating to:

     *   Product authorisation.
     *   Product safety.
     *   Pharmacovigilance.
     *   Adverse event reporting.
     *   Risk-benefit assessments.
     *   Regulatory actions.
     *   Label changes.
     *   Safety warnings.

B. Conflicts of Interest

For all individuals involved in the assessment, authorisation, review, pharmacovigilance monitoring, safety evaluation, inspection, or regulatory decision-making concerning Librela or Solensia, please provide:

  *   Declarations of interests.
  *   Conflict-of-interest disclosures.
  *   Records of recusals or exclusions from decision-making processes.
  *   Policies governing conflicts of interest applicable during the relevant period.
  *   Any identified actual, potential, or perceived conflicts of interest and how they were managed.

C. Expert and Advisory Committee Involvement

Please provide:

  *   The names of any advisory committees, expert working groups, or external experts involved in decisions relating to Librela or Solensia.
  *   Copies of declarations of interest for committee members and experts.
  *   Any payments, honoraria, expenses, consulting fees, or other remuneration paid in relation to such work.

1.11 Regulatory Inspection Costs and Cost Recovery

For each calendar year, please provide in relation to Librela and Solensia:

  *   The total cost incurred by the VMD for inspections associated with these products.
  *   A breakdown of costs by:
     *   Inspector salaries and staff time.
     *   Travel expenses.
     *   Accommodation expenses.
     *   Subsistence expenses.
     *   Administrative support costs.
     *   Laboratory or testing costs.
     *   Contractor or external expert costs.
     *   Any other inspection-related expenditure.
  *   The amount invoiced to and recovered from the manufacturer or marketing authorisation holder.
  *   Any unrecovered inspection costs borne by the VMD or public funds.
  *   The country and facility inspected.
  *   The inspection type (GMP, GDP, pharmacovigilance, pre-authorisation, for-cause, risk-based, follow-up, etc.).
  *   Copies of inspection reports, findings summaries, deficiency notices, and corrective action requests where disclosure is permitted.

1.12 Statutory Compliance and Regulatory Oversight Costs

For each calendar year, please provide:

  *   The total VMD staff time spent on regulatory oversight of Librela and Solensia.
  *   The total cost incurred by the VMD in monitoring compliance with statutory and regulatory obligations relating to these products.
  *   Costs associated with:
     *   Pharmacovigilance assessments.
     *   Signal detection activities.
     *   Safety investigations.
     *   Risk-benefit reviews.
     *   Enforcement activities.
     *   Legal review.
     *   Scientific assessment.
     *   Data validation and analysis.
     *   External expert consultation.
  *   Any extraordinary or unplanned regulatory expenditure associated with these products.
  *   Any internal estimates of the total regulatory resources dedicated to these products.

1.13 Compliance Failures, Late Reporting, and Enforcement Action

For each calendar year, please provide:

  *   The number of instances in which the marketing authorisation holder, manufacturer, distributor, or any associated party failed to comply with statutory or regulatory reporting requirements relating to Librela or Solensia.
  *   Details of any missed reporting deadlines.
  *   Details of any delayed adverse event reporting.
  *   Details of any delayed pharmacovigilance submissions.
  *   Details of any delayed Periodic Safety Update Reports (PSURs) or equivalent safety submissions.
  *   Details of any delayed signal reporting or safety communications.
  *   The length of each delay.
  *   The reason recorded for each delay.
  *   Any correspondence relating to such delays.

1.14 Thirty-Day Reporting Requirement Compliance

For each calendar year, please provide:

  *   The number of adverse event reports or regulatory submissions relating to Librela and Solensia that were not submitted within the statutory 30-day reporting period.
  *   The number submitted late.
  *   The average delay beyond the statutory deadline.
  *   The longest recorded delay.
  *   Any investigations conducted by the VMD regarding late reporting.
  *   Any corrective or preventive actions required by the VMD.
  *   Any compliance findings issued.
  *   Any sanctions, penalties, enforcement measures, warnings, deficiency notices, or other regulatory actions imposed.

1.15 Financial Penalties and Enforcement Outcomes

For each calendar year, please provide:

  *   Details of any financial penalties, fines, sanctions, enforcement notices, warning letters, or compliance actions issued in connection with Librela or Solensia.
  *   The legal basis for each action.
  *   The date of each action.
  *   The amount of any financial penalty imposed.
  *   Whether the penalty was paid, appealed, reduced, withdrawn, or otherwise resolved.
  *   Any settlement agreements entered into.
  *   Any ongoing investigations relating to regulatory compliance.

1.16 VMD Internal Assessment of Compliance

Please provide:

  *   Any internal reports, audits, reviews, briefing papers, risk assessments, or management reports concerning compliance by the marketing authorisation holder of Librela or Solensia with UK pharmacovigilance, manufacturing, reporting, or regulatory requirements.
  *   Any documents discussing concerns regarding delayed reporting, data quality, completeness of adverse event reporting, signal detection, or regulatory compliance.
  *   Any risk ratings assigned to these products or their marketing authorisation holder

1.17 Regulatory Resource Allocation Triggered by Safety Concerns

For each calendar year, please provide:

  *   Whether Librela or Solensia required enhanced monitoring, increased regulatory oversight, targeted inspections, special investigations, or additional pharmacovigilance resources beyond routine regulatory activities.
  *   The reason for any such enhanced monitoring.
  *   The additional costs incurred by the VMD.
  *   The number of additional staff hours dedicated to such activities.
  *   Any internal assessments of the impact of these products on VMD regulatory resources.

2. Our reply

We have considered your request under the Freedom of Information Act 2000.

We are refusing this request under section 14(1) as we consider it to be vexatious.

In reaching this conclusion, we have taken into account the significant breadth and complexity of the request. It seeks detailed, multi-year information across a wide range of regulatory, financial, inspection, pharmacovigilance and operational areas relating to two products. Responding in full would require extensive searches across multiple business areas, extraction of detailed records, and substantial collation and review.

We have also considered the wider context in which this request has been submitted. The VMD has received a number of requests from different individuals covering similar subject matter, many of which overlap with elements of this request. In several cases, information has already been disclosed and is, or will be in due course, publicly available via previously published FOI responses.

We consider that this request consolidates and extends those earlier requests in a way that would impose a disproportionate burden on the VMD, with limited additional value beyond information that is already available.

For these reasons, we consider the request to be vexatious under section 14(1) of the Act.

To assist you, previously disclosed information can be accessed via Transparency and freedom of information releases - GOV.UK.

Details about our application, inspection, and annual fees are published Fees relating to Marketing Authorisations (MA) - GOV.UK.

If you wish to submit a new request, we would encourage you to focus on specific information that has not already been requested or published, which we would be happy to consider.