Guidance

Business Priority 3 – Delivery of core regulatory services:

Published 28 September 2020

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

1.1 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. These are the 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

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

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

• To 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’, 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
• Reference to EU procedures will be removed at the end of the transition period

1.3 Applications

No.		Procedure		Details of target
1		Major timetable (National) Maximum Residue Limit (MRL). All other new MA applications (excl. Marketing Authorisation for Parallel Import (MAPI) and Copycats) Variation-extensions		Decision to approve or refuse an application is completed within 180 days of receipt of a valid application. This will be extended to 210 days where application is deemed to be complex, determined at the validation from set criteria e.g. 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.
2		Standard timetable (National) Type II variations, New MA – MAPIs and Copycats, New Veterinary Homeopathic Registrations (VHR)		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 Animal Test Certificate (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		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 45
7		Mock-Ups		Complete assessment of mock-ups within 20 days of receipt. Complete assessment of mock-ups within 20 days of receipt of correct/revised versions following completion of the scientific assessment phase of decentralised procedures (until the end of the transition period), Mutual Recognition procedures (until the end of the transition period) and National MA and VHR procedures
8		Validation		Validate all applications within 10 days of receipt except for: ATCs – within 5 days, European Decentralised – within 14 days (until the end of the transition period), CMS Type IB Variations – within 5 days (until the end of the transition period)
9		Issue of authorisation documentation		Issue authorisation documentation following conclusion of scientific or mock-up assessment, within 10 days or within 5 days for ATCs and Specific Batch Control and within 30 days for Grouped Type IA applications and Workshare applications
10		New Centralised (CAP)		UK Role: Comment. Send Day 100 comments in accordance with the timetable (until the end of the transition period)
11		New Decentralised (DCP)		UK Role: CMS. Send Day 100 comments in accordance with the phase 1 timetable (until the end of the transition period)
12		New Mutual Recognition (MRP) and New DCP		UK Role: CMS. Send confirmation of UK position in accordance with the phase 2 timetable (until the end of the transition period)
13		MRP Variations (Type IB & II) and Renewals		UK Role: CMS. Send UK comments in accordance with the phase 1 timetable (until the end of the transition period)
14		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 and 30 days for parallel MR type 2 variations (shortened timetable)
15		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
16		Referrals		For applications where a referral has been initiated will be considered at the next available VPC meeting after the referral has been lodged; with the outcome of the referral being communicated within 10 days of its conclusion

1.4 Public Assessment Reports

No.		Procedure		Details of target
17		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
18		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)
19		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. For centralised applications, it will be available on the EMA website. (until the end of the transition period)

1.5 Quality of Authorisation Documentation

No.		Details of target
20		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
21		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
22		Special Import Certificate (SIC) / Wholesale Dealers’ Import Certificate (WDIC): Requiring assessment		Applications for new products (those not previously assessed for importation into the UK): To approve or refuse applications within 15 days of receipt
23		Special Import Certificate (SIC) / Wholesale Dealers’ Import Certificate (WDIC): Requiring assessment		All other applications:To approve or refuse applications within 2 days for applications where use of the product is urgent, 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

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		Inspections: Good Manufacturing Practice (GMP), Good Distribution Practice (GDP)		Inspections performed at relevant sites on a risk-basis and within 3 years (GMP) or 5 years (GDP) of the last inspection. Under exceptional circumstances the maximum periods above may be extended provided that this is justified by a documented risk assessment, based on formal, defined criteria
31		Final Inspection Reports		Within 90 days of an inspection, issue initial inspection report, assess company’s responses of corrective/preventive actions, and issue final inspection report (with GMP certificate for manufacturers)

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

1.11 Publication of results

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.

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^{[footnote 1]} 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.

1. Certificate (ATC) 6 x the number of category / application types that qualify for the inclusion in the overall score, i.e. involving 12 or more data points ↩