Guidance

Published standards for regulatory work 2026/2027

The published standards relate to a number of KPIs in the VMD Deliverables.

• From: Veterinary Medicines Directorate
• Published: 7 May 2026

Business Priority 3 – Delivery of core regulatory services:

A) Facilitate optimal availability and safe use of veterinary medicines

In support of the above Business Priority, 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 Pharmacovigilance findings to the Veterinary Products Committee and publish those findings

• To evaluate all Product Defect reports 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.

*Performances indicators for the main different types of marketing authorisation application work, the recording and assessment of pharmacovigilance data, some inspection work and the publication of summary of product characteristics (SPC) and public assessment reports.

Performance Areas Covered:

1. Applications
2. Public Assessment Reports (PuARs)
3. Quality of documentation
4. Product defects
5. Import, export and batch release schemes
6. Pharmacovigilance
7. Inspections (GMP and GDP)
8. Enforcement
9. Residues
10. 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

No.	Procedure	Details of target
1	Complex/Major timetable (National) Complex new MA (Marketing Authorisation) applications, e.g. novel therapies, new actives.	Decision to approve or refuse an application is completed within 210 days (complex)/ 180 days (major) of receipt of a valid application. The major timetable will be extended to 210 days where an application is deemed to be complex.
2	Standard timetable (National), VRA-S variations, New MA – Copycats, New VHRs (Veterinary Homeopathic Registrations)	Decision to approve or refuse an application is completed within 120 days of receipt of a valid application.
3	Shortened timetable (National), VRA-R variations, New ATC (Animal Test Certificate) (Type A, B, S), ATC variations	Decision to approve or refuse an application is completed within 60 days of receipt of a valid application.
4	Minor timetable (National), VNRA variations, Administrative VRA-R variations, ATC renewals	Decision to approve or refuse an application is completed within 30 days of receipt of a valid application. ATC renewals actioned within 30 days.
5	Batch timetable (National), Specific Batch Control	Decision to approve or refuse an application is completed within 20 days of receipt of an application.
6	Autogenous Vaccines, New & Variations	Complete scientific assessment by Day 60.
7	EU Procedures, New & Variations	European procedures completed by sign off target (excluding centralised procedures). New MA – 10 days, VRA-S – 20 days, VRA-R – 20 days
8	Mock-Ups	Mock up period completed within 20 days.
9	Packaging Surveillance	Packaging assessment completed within 3 months of selection.
10	Validation	Validate all applications within 10 days of receipt except for: ATCs – within 5 days, European Decentralised – within 15 days, CMS VRA-R Variations – within 5 days
11	Issue of authorisation documentation	Issue authorisation documentation following conclusion of scientific or mock-up assessment: Within 5 days for: ATCs, Specific Batch Control. Within 15 days for: new MA applications, variation applications

2. Public Assessment Reports

No.	Procedure	Details of target
12	Publishing Summary of Product Characteristics (SPCs)	Make the Summary of Product Characteristics (SPCs) available via the Product Information Database (PID) within 30 days of issue of a new MA.
13	Publishing Public Assessment Reports (PuARs)	Make the public assessment report (PuAR) available via the PID within 120 days of approval or refusal of an application for a new MA or veterinary homeopathic registration (VHR).
14	Updating PuARs	If required, update the PuAR following a change to a MA or VHR within 60 days of granting the change.

Following completion of an MRP (Mutual Recognition Procedure) or DCP (Decentralised Procedure) application, the PuAR should be available from the RMS (Reference Member State).

3. Quality of Authorisation Documentation

No.	Details of target
15	To record the number of applications issued correctly, i.e. not returned as containing errors.

4. Product Defects

No.	Procedure	Details of target
16	Product Defects	Respond to product defect reports within 10 working days

5. Import, Export and Batch Release Schemes

No.	Procedure	Details of target
17	Special Import Certificate (SIC) / Wholesale Dealers’ Import Certificate (WDIC): Requiring assessment	Applications for new* products: To approve or refuse applications within 15 days (Pharm) and 25 days (Imm) of receipt. *New products are those not previously assessed for importation into the UK.
18		Applications for previously imported products: To approve or refuse applications for New species and new stock use within 15 days of receipt.
19		All other applications: To approve or refuse applications within 2 or 10 days of receipt.
20	Special Import Certificate (SIC): Not requiring assessment	All instant certificates applied for through the online system.
21	Export Certificates	Accept or reject applications within 10 days of receipt.
22	Batch Release Requests (BRRs) Immunologicals	Accept or reject requests within 10 days of receipt.

6. Pharmacovigilance

No.	Details of target
23	Validate as required all human, animal and environmental adverse event reports within 30 calendar days of receipt of the required information.
24	Send the final inspection report to inspected Marketing Authorisation Holder (MAH) within 90 calendar days of the closing meeting.
25	Number of Benefit-Risk reports validated within 60 calendar days of receipt of the required information.
26	Number of Benefit-Risk Reports undergoing full assessment completed within 120 calendar days of receipt of the required information.
27	Number of standard signal notifications fully processed within 60 calendar days of receipt of the required information.
28	Number of urgent signal notifications fully processed within 3 working days of receipt of the required information.

7. Inspections

No.	Procedure
29	Inspections performed at relevant sites on a risk-basis within 3 years (GMP) or 5 years (GDP) of the last inspection
30	Within 30 days of the last day on site, send inspection deficiency report to manufacturers (GMP and other manufacturing sites) or wholesalers (GDP). This applies to inspections where the VMD is the sole inspectorate.
31	Within 90 days of the last day on site, send GMP Certificates to manufacturers
32	Authorisation of new Feed business operators and SQP retailer sites within 45 days of application validation
33	Within 30 days of the last day on site, issue the inspection report to Veterinary Practice Premises, Feed business operators and SQP retailers

Details of Target

Manufacturing Authorisations:

1. Validate applications for authorisation within 10 days.
2. Inspect new UK veterinary-only manufacturing sites within 90 days of the application being validated.
3. Conduct risk-based inspections of UK veterinary-only manufacturing sites at a frequency not exceeding 3 years*.
4. 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), where applicable, within 90 days of completing the inspection.

This only applies to inspections where the VMD is the sole inspectorate.

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

Wholesaling Authorisations:

1. Validate applications for authorisation within 10 days.
2. Inspect new UK wholesaling sites within 90 days of the application being validated.
3. Conduct risk-based inspections of UK wholesaling sites at a frequency not exceeding 5 years*.
4. 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:

1. Validate applications for authorisation within 10 days.

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

Veterinary Practice Premises, Feed Business Operators & SQP Retailers:

1. 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

No.	Details of target
34	Publication of GB enforcement notices within 5 working days of receipt. To publish GB served seizure notices and improvement notices on gov.uk within 5 working days of receipt into the enforcement mailbox.
35	Initiate the removal of illegal listings on both social media and marketing platforms within 10 working days of allocation. To ensure that all listings are reported to either the social media platform or marketing platform within 10 working days of allocation to the case officer. This follows both the triage and booking in process.

9. Residues

No.	Procedure	Details of target
36	Publication of results	Publication of residues non-compliance data once a quarter, as well as publication of each full year’s worth of monitoring by the 30 April in any given year.
37	Testing of samples	Ensuring the testing laboratory completes testing of samples within 7 calendar days for ‘suspect’ samples and 28 days for ‘routine’ samples, over 90% of the time.

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:

Assurance Level	Outcome of the VPC Evaluation
Substantial - The assessment is adequate and effective	The VMD identified all potentially serious risks to human and animal health or for the environment within the context of the existing regulatory framework and put together a comprehensive list of relevant questions for the applicant which were clearly expressed, justified/explained and pivotal to the benefit:risk assessment.
Moderate - Some improvements are required to enhance the adequacy and effectiveness of the assessment	The VMD identified all potentially serious risks to human and animal health and for the environment and posed suitable questions which on the whole were easy to understand but in some cases could have been clearer and/or included questions to which the answers were nice to know rather than pivotal to the benefit-risk assessment.
Limited - There are significant weaknesses in the assessment	The VMD failed to identify an individual potentially serious risk to human or animal health or for the environment and linked to this failed to send suitable questions to the applicant.
Unsatisfactory - There are fundamental weaknesses in the assessment such that it is inadequate and ineffective	The VMD failed to identify a number of potentially serious risks to human or animal health or for the environment and linked to this failed to send suitable questions to the applicant.

Published 7 May 2026