Veterinary Medicines Directorate
May 13
09:28
2024
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:
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Monitor our performance against the Published standards which set out the timelines and performance categories for a range of key functions. These are performance 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
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Report PhV findings to the Veterinary Products Committee and publish those findings
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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. 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:
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With the exception of the schemes, which run on working days, all other timescales run on calendar days
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Days are clock days, that is, the days when the clock is running and the application is with the VMD for action
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If the VMD fails to meet a deadline due to the actions of a third party this will not count as a missed target
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For procedures on joint-labelled products, the clock may stop at any time to enable communication with Ireland
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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 timetable (National): Complex new MA (Marketing Authorisations) applications, such as novel therapies, new actives. | Decision to approve or refuse an application is completed within 210 days of receipt of a valid application |
| 2 | Major timetable (National): MRLs (Maximum Residue Limits). All other new MA applications (excl. MAPI (Marketing Authorisation for Parallel Import) 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. This is determined at the validation from 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) |
| 3 | Standard timetable (National): Type II (VRA) variations New MA MAPIs and Copycats, New VHRs (Veterinary Homeopathic Registrations) | Decision to approve or refuse an application is completed within 120 days of receipt of a valid application |
| 4 | Shortened timetable (National): Renewals (MA & VHR), Type IB (VRA) variations New ATC (Animal Test Certificate) (Type B) | Decision to approve or refuse an application is completed within 60 days of receipt of a valid application |
| 5 | Minor timetable (National): Type IA (VNRA) variations, Administrative Type IB (VRA) variations, New ATC (Type A / Type S), ATC variations & renewals | Decision to approve or refuse an application is completed within 30 days of receipt of a valid application |
| 6 | 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 (VRA) variations (extended timetable), centrally authorised type 2 variations; 30 days for parallel MR type 2 (VRA) variations (shortened timetable); 60 days for parallel MR type 1B (VRA) variations; 90 days for parallel MR renewals |
| 7 | 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 |
| 8 | Batch timetable (National) Specific Batch Control | Decision to approve or refuse an application is completed within 20 days of receipt of an application |
| 9 | Autogenous Vaccines: New & Variations | Complete scientific assessment by Day 45 |
| 10 | 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 |
| 11 | Validation | Validate all applications within 10 days of receipt except for: ATCs within 5 days; European Decentralised within 15 days; CMS Type IB (VRA) Variations within 5 days |
| 12 | 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 |
| 13 | New Decentralised (DCP) | NI Role: CMS, Send Day 100 comments in accordance with the phase 1 timetable |
| 14 | New Mutual Recognition (MRP) | NI Role: CMS; Send confirmation of NI position in accordance with the phase 2 timetable |
| 15 | MRP Variations: VRA Type IB & II | NI Role: CMS; Send NI comments in accordance with the phase 1 timetable |
2. Public Assessment Reports
| No. | Procedure | Details of target |
|---|---|---|
| 16 | 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 |
| 17 | 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) |
| 18 | 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.
3. Quality of Authorisation Documentation
| No. | Details of target |
|---|---|
| 19 | To record the numbers of unreturned authorisation documents as a percentage in relation to those issued. |
4. Product Defects
| No. | Procedure | Details of target |
|---|---|---|
| 20 | Product Defects | Respond to: high risk product defect reports within 5 working days; other product defect reports within 10 working days |
5. Import, Export and Batch Release Schemes
| No. | Procedure | Details of target |
|---|---|---|
| 21 | Special Import Certificate (SIC) / Wholesale Dealers Import Certificate (WDIC): Requiring assessment | Applicatio
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