Guidance

Published standards for regulatory work 2021/2022

Published 8 September 2021

1. Business Priority 3 – Delivery of core regulatory services:

1.1 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

• Achieve an overall performance of ≥92%, which is effective

• 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. The VMD will monitor progress against these targets on a monthly basis. At the end of the year the results against these standards will be published. The way in which this information will be presented is detailed at the end of this document.

1.2 Performance Levels

• Ineffective <92%
• Effective >92-97%
• Excellent > 97%

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. 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’, that is, 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

• Complex applications are determined at the validation from a set criteria, such as, novel therapy, new active substances to veterinary medicines in the UK, combination of actives new to veterinary medicines in the UK, applications submitted under partnership / co-assessment arrangements, recombinant DNA applications and monoclonal antibody applications, immunological applications (except informed consent), etc.

1.3 Applications

No.	Procedure	Details of target
1	Major timetable (National): MRLs .All other new MA applications (excl. MAPI and Copycats) Variation-extensions	Decision to approve or refuse an application is completed within 180 days of receipt of a valid application. Will be extended to 210 days where application is deemed to be complex
2	Standard timetable (National): Type II variations New MA – MAPIs and Copycats New VHRs	Decision to approve or refuse an application is completed within 120 days of receipt of a valid application.
3	Shortened timetable (National): Renewals (MA & VHR) Type IB variations New ATC (Type B)	Decision to approve or refuse an application is completed within 60 days of receipt of a valid application.
4	Minor timetable (National) Type IA variations Administrative Type IB variations New ATC (Type A / S) ATC variations & renewals	Decision to approve or refuse an application is completed within 30 days of receipt of an (valid) application.
5	Parallel Assessment with EU Procedures	Following receipt of a valid application, decision to approve or refuse within: 210 days for parallel new and variation-extension DCP and centrally authorised procedures : 120 days for parallel MR type 2 variations (extended timetable), centrally authorised type 2 variations; 30 days for parallel MR type 2 variations (shortened timetable); 60 days for parallel MR type 1B variations; 90 days for parallel MR renewals
6	Shared Assessment with International Partners	For shared assessment or workshare with international partners to reach a decision to approve or refuse within: 210 days or as per the agreed contract / arrangement
7	Batch timetable (National): Specific Batch Control	Decision to approve or refuse an application is completed within 20 days of receipt of an application.
8	Autogenous Vaccines New & Variations	Complete scientific assessment by Day 45.
9	Mock-Ups	Complete assessment of mock-ups within 20 days of receipt (or up to 40 days for parallel applications involving different QRD sources). Complete assessment of mock-ups within 20 days of receipt of correct/revised versions following completion of the scientific assessment phase of: Decentralised procedures, Mutual Recognition procedures, National MA and VHR procedures
10	Validation	Validate all applications within 10 days of receipt except for: ATCs – within 5 days, European Decentralised – within 14 days, CMS Type IB Variations – within 5 days
11	Issue of authorisation documentation	Issue authorisation documentation following conclusion of scientific or mock-up assessment, within 10 days, or: Within 5 days for ATCs, Specific Batch Control. Within 10 days for new MA applications, variation applications involving <9 products/ changes. Within 30 days for: Variation applications >9 products/ changes, Workshare applications
12	New Decentralised (DCP)	NI Role: CMS: Send Day 100 comments in accordance with the phase 1 timetable.
13	New Mutual Recognition (MRP)	NI Role: CMS. Send confirmation of NI position in accordance with the phase 2 timetable.
14	MRP Variations (Type IB & II) and Renewals	NI Role: CMS. Send NI comments in accordance with the phase 1 timetable.

1.4 Public Assessment Reports

No.	Procedure	Details of target
15	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.
16	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).
17	Updating PuARs	If required, update the PuAR following a change to an MA or VHR within 60 days of grant of that change.

• Following completion of an MRP or DCP application, the PuAR should be available from the RMS.

1.5 Quality of Authorisation Documentation

No.	Details of target
18	To record the numbers of unreturned authorisation documents as a percentage in relation to those issued.

1.6 Product Defects

No.	Procedure	Details of target
19	Product Defects	Respond to high risk product defect reports within 5 working days and other product defect reports within 10 working days

1.7 Import, Export and Batch Release Schemes

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

• New products are those not previously assessed for importation into the UK.

1.8 Pharmacovigilance

No.	Details of target
27	Input, assess and transmit as required to interested parties all human, animal and environmental adverse event reports and follow-up messages within 15 calendar days of receipt of the required information.
28	Validate, extract and analyse all UK data from Periodic Safety Update Reports within 50 calendar days of receipt.
29	Send the final inspection report to inspected Marketing Authorisation Holder (MAH) within 90 calendar days of the closing meeting.

1.9 Inspections

No.	Procedure	Details of target
30-32	Inspections performed at relevant sites on a risk-basis: within 3 years (GMP) or 5 years (GDP) of the last inspection. Within 30 days of the last day on site, send inspection deficiency report to manufacturers (GMP) or wholesalers (GDP). Within 90 days of the last day on site, send GMP Certificates to manufacturers.	Good Manufacturing Practice (GMP): 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(a). 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(a). 5.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): 1.Validate applications for authorisation within 10 days. 2. Inspect new UK veterinary-only wholesale dealer sites within 90 days of the application being validated. 3. Conduct risk-based inspections of UK veterinary-only wholesale dealer sites at a frequency not exceeding 5 years(a) 4. Issue the inspection deficiency report within 30 days of completing the inspection.
33- 34	Approval of new Feed business operators and SQP retailer sites within 45 days of application validation. Within 30 days of the last day on site, send final inspection report to Feed business operators and SQP retailers	Feed Business Operators & SQP Retailers: 1.Validate applications for approval within 10 days. 2. 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.

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

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.

1.10 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:

Level	Outcome of the VPC Evaluation
1	The VMD identified all potentially serious risks to human and animal health or for the environment 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.
2	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.
3	The VMD identified all potentially serious risks to human and animal health and for the environment however generally the questions posed weren’t sufficiently clear and easy to understand.
4	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.
5	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.

2. Publication of results

2.1 Individual Results

Our performance against each target will be published at the end of the year for each category / application type involving at least 12 items / applications.

2.2 Overall Results

The following system will be used to obtain a score as an overall measure of the performance.

• Excellent – 6 points
• Effective – 4 points
• Ineffective – 0 points

A total score will then be calculated and this will be judged against the following overall criteria:

• Total point score of more than Y (Y calculated as maximum possible score x 0.97) = Excellent

• Total point score of X to Y = Effective

• Total point score of less than X (X calculated as maximum possible score x 0.92) = Ineffective

The overall score for will be published at the end of the financial year.