Notice

MAVIS Hub Edition 121

Published 4 February 2022

1. Product news

Revozyn RTU 400 mg/ml Suspension for Injection for Cattle - Product defect recall alert

Clindacutin Ointment 10 mg/g for dogs - Product defect recall alert

Availability of Lactating Cow Intramammary Antibiotics

Nerfasin 20mg/ml Solution for Injection for Cattle, Horses, Dogs and Cats - Product defect recall alert

Withdrawal of marketing authorisations of veterinary medicines containing Zinc Oxide

2. Enforcement

Animal medicine seizure notice: Parcel addressed to residential premises in Guildford, Surrey

Animal medicine seizure notice: Caledonia Dressage Horses, Sutherland, Scotland

Animal medicine seizure notice: Parcel addressed to veterinary premises in Kingston, Surrey

3. AMR (Antimicrobial Resistance)

3.1 Defra Antimicrobial Resistance Co-ordination (DARC) group

The DARC group met virtually on 30 November 2021 to discuss the recent findings on AMR in bacteria of importance to animal and public health. This meeting also included an update from the FSA on the Pathogen Surveillance in Agriculture, Food and the Environment (PATH-SAFE) project and a presentation on AMR in the environment.

Minutes from previous meetings.

3.2 Policy and Communications

Priorities for this year include continued implementation of animal health-specific aspects of the cross-government UK AMR National Action Plan (2019-2024) and publication of a Case Study report written by the VMD and stakeholders detailing the UK’s reduction in sales and use of antibiotics for food-producing animals. The report will be published by the Food and Agriculture Organisation of the United Nations and highlight the value of the multi-sectoral voluntary collaborative approach adopted in the UK.

In 2021, the UK’s hosting of the G7 Presidency saw commitments on AMR made in the health ministers’ declaration, the climate and environment ministers’ declaration and the finance ministers’ declaration. These included commitments on AMR in the environment stemming from antimicrobial drug manufacturing, consideration of options for strengthening supply chains, and exploration of antimicrobial valuation principles and market incentives. On 1 January 2022, Germany assumed the G7 Presidency and has set out a prevention and transformation agenda for the G7 Foreign Ministers.

On the 9 November 2021, the VMD published the annual UK-VARSS 2020 report. This year’s report shows that reductions in antibiotic use in farmed animals achieved in previous years have been held steady, and there have been decreasing trends in AMR in indicator bacteria.

For this year’s World Antimicrobial Awareness Week (18 – 24 November), VMD created a twitter campaign which encompassed general AMR facts, AMR in the environment and results from the UK-VARSS report. The Government Veterinary Services published a blog by Kitty Healey: World Antimicrobial Awareness Week 2021: Reflections on the Veterinary Medicines Directorate’s AMR work.

3.3 Usage and Stewardship

The usage and stewardship teams continue to engage with the livestock sectors and provide secretariat to sector stewardship groups, including the Cattle Antibiotic Guardian Group and Pi Health and Welfare Council Antimicrobial Usage Subgroup.

Facilitating the development and promotion of the recently launched industry Medicine Hubfor ruminants is a key focus, as this will make it possible to bring together antibiotic usage data for cattle and sheep. This data means that national usage can be tracked, and benchmarking will also facilitate discussions between vets and farmers on disease prevention and responsible antibiotic use.

The team are also working with Farm Vet Champions initiative, to provide free CPD on antibiotic stewardship and disease prevention and support the development of the second phase – which will make it possible for practices and individuals to set SMART goals around improving antibiotic use. Further information is available on the RCVS Knowledge platform.

Companion Animals and Horses are also an important focus for 2022, and the team will work closely with the newly formed RUMA Companion Animal and Equine group as well as the development of the new RCVS Knowledge auditing and benchmarking tool for Companion Animals

4. Inspections

During the period from 01/10/21 to 31/12/21 the Distribution and Supply Chain Inspection Section carried out a total of 260 inspections of retail and feed business premises to assess their compliance with the Veterinary Medicines Regulations 2013. We have restarted on-site inspections however due to the ongoing pandemic we are still carrying out some remote assessments where we believe they are appropriate.

4.1 Retail Premises

We inspected 217 retail premises (veterinary practice premises and SQP retailers) and the compliance ratings for these inspections were as follows (5 being the highest, 1 being the lowest):

Rating No. of premises Percentage
5 60 28%
4 122 56%
3 31 14%
2 4 2%
1 0 0%

The most common deficiencies that required corrective action, which were all observed in veterinary practice premises were:

  1. Broach dates exceeded or not recorded
  2. Controlled Drug (CD) Registers not maintained as required
  3. Insufficient record keeping at receipt or supply

The requirements for retailers are published on Gov.UK

4.2 Feed Business Operator premises

We inspected 43 Feed Business Operator (FeBO) premises and the compliance ratings for these inspections were as follows (5 being the highest, 1 being the lowest):

Rating No. of premises Percentage
5 15 35%
4 24 56%
3 4 9%
2 0 0%
1 0 0%

The most common deficiencies that required corrective action were:

  1. HACCP plan not documented/implemented/maintained as required
  2. Homogeneity testing issues
  3. Hygiene concerns

The requirements for Feed Business Operator (FeBO) premises are published on Gov.UK

5. Guidance Updates

United Kingdom-Canada Regulatory Cooperation: Guidance on Veterinary Drug Simultaneous Reviews

Report a product defect: veterinary medicine

Mitigations: UK Veterinary Medicines Regulations from January 2022

VMD Information Hub

Veterinary medicine wholesale dealer’s authorisation (WDA)

Coronavirus (COVID-19) VMD News and Guidance

VMD temporary enforcement policy under specific COVID‐19 circumstances

Controlled drugs: recording, using, storing and disposal

Veterinary Pharmacovigilance responsibilities for authorisation holders

Pharmacovigilance of Veterinary Medicines in Great Britain

Mitigation explainer: Pharmacovigilance

Mitigation explainer: Labelling text

Mitigation explainer: Variations

Apply to renew a marketing authorisation for a veterinary medicine

Mitigation explainer: Renewals

Fees applied to animal medicine authorisation applications

Marketing Authorisation Holders, Named Distributors and Local Representatives of veterinary medicines

EU Regulations 2019/6 and 2019/4 will not be implemented in Northern Ireland

6. Research and statistics

Veterinary Antimicrobial Resistance and Sales Surveillance 2020

VMD Published Standards 2021 to 2022: Monitoring performance

Top ten imported veterinary medicines - Quarterly report 1 October 2021 to 31 December 2021

Residues of veterinary medicines in food: 2021

7. Stakeholder engagement

UK veterinary antibiotics sales more than halved over the past six years

Online training for veterinary Wholesale Qualified Persons (WQPs)

Joint VMD and VPC open information day - 29 November 2021

Training course for Veterinary Dispensary Managers

VMD hosts Equine Anthelmintic Resistance Stakeholder Workshop

8. Corporate News

VMD Regulatory Science Strategy 2021-2026

8.1 Organogram as at 31 January 2022

VMD Organogram