Published standards for regulatory work 2025/26
Source: gov.uk (2025-05-21)

These published standards relate to Corporate Priority 3 – Regulatory Service.

Corporate Priority 3 - Regulatory Service

In support of Corporate Priority 3 (https://www.gov.uk/guidance/vmd-corporate-priorities-2025-2026#priority-3---regulatory-service) – Regulatory Service, we commit to:

Monitor our performance against the Published standards which set out the timelines and performance categories for a range of key functions.

Report PhV findings to the Veterinary Products Committee and publish those findings

Evaluate all Product Defect reports and respond to ‘High Risk’ ones within 5 working days; and all others within 10 working days

This document sets out the standards to which the VMD will operate. At the end of the year the results against these standards will be published.

Performance Areas Covered:
- Applications
- Public Assessment Reports (PuARs)
- Quality of documentation
- Product defects
- Import, export and batch release schemes
- Pharmacovigilance
- Inspections (GMP and GDP)
- Enforcement
- Residues
- Evaluation of Applications
Note:

With the exception of the ‘schemes’, which run on working days, all other timescales run on calendar days

Days are ‘clock days’, i.e. the days when the clock is running and the application is with the VMD for action

If the VMD fails to meet a deadline due to the actions of a third party this will not count as a missed target

For procedures on joint-labelled products, the clock may stop at any time to enable communication with Ireland

For all procedures, the clock may be stopped at any time to enable the VMD to get further information from the applicant, advice from a third party, expert committee, or to ensure a new MA application can be considered by the appropriate peer review committee

1. Applications

2. Public Assessment Reports

3. Quality of Authorisation Documentation

4. Product Defects

5. Import, Export and Batch Release Schemes

6. Pharmacovigilance

7. Inspections

Details of target

Good Manufacturing Practice (GMP)

Validate applications for authorisation within 10 days.

Inspect new UK veterinary-only manufacturing sites within 90 days of the application being validated.

Conduct risk-based inspections of UK veterinary-only manufacturing sites at a frequency not exceeding 3 years**.

Conduct risk-based inspections of non-UK veterinary-only manufacturing sites at a frequency not exceeding 3 years unless an arrangement is in place whereby the site is inspected by another Competent Authority with equivalent regulatory controls**.

Issue the inspection deficiency report within 30 days of completing the inspection; and issue the GMP certificate (or Statement of Non-Compliance) within 90 days of completing the inspection.

Good Distribution Practice (GDP)

Validate applications for authorisation within 10 days.

Inspect new UK veterinary-only wholesale dealer sites within 90 days of the application being validated.

Conduct risk-based inspections of UK veterinary-only wholesale dealer sites at a frequency not exceeding 5 years. **

Issue the inspection deficiency report within 30 days of completing the inspection.

**in exceptional circumstances these intervals may be extended if a detailed risk assessment is conducted and approved by the Head of Inspections Division/Director.

Feed Business Operators & SQP Retailers

Validate applications for approval within 10 days.

Approve new Feed business operators and SQP retailer sites within 45 days of the application being validated.

3. Issue the inspection report within 30 days of completing the inspection.

Note: Pharmaceutical assessors and / or GMP inspectors will liaise as necessary with inspectors at the Medicines Healthcare and products Regulatory Agency (MHRA) in connection with the inspection of sites producing and / or wholesaling veterinary and human pharmaceutical products where the UK is the Supervisory Authority.

8. Enforcement

9. Residues

10. Evaluation of Applications

Assessments will be conducted by suitably qualified and trained staff who will undertake appropriate Continuing Professional Development (CPD).

The assessment of applications for new MAs will be subject to an internal peer review process, and review by SciSec or Bio, which are meetings that may involve other government departments. In a limited number of cases, where specialist advice is required, applications may also be subject to external review by the Veterinary Products Committee (VPC).

Assessments will take into full account:
- Relevant legislation
- The European Pharmacopoeia (or where relevant another EU Pharmacopoeia)
- Relevant guidelines
- VICH guidelines
- Precedents set during previous procedures
- Any relevant information from the scientific literature which may be known to the assessor.
In reaching decisions on authorisations the benefits associated with the use of the product will be weighed up against the risks.

On an annual basis a sample of assessments performed by the VMD on applications to obtain new MAs, which have been initially assessed by the VMD, will be examined by the VPC and these will be ranked according to the following criteria: