Notice

MAVIS Hub Edition 130

Published 10 May 2024

1. Product News

Urgent safety updates for veterinary medicines - 12 April 2024

Prevomax 10 mg/ml Solution for Injection for Dogs and Cats – SPC change - 11 April 2024

Product defect recall alert for Purevax® RCP and Eurican Herpes products - 26 March 2024

Apoquel Tablets for Dogs - change to SPC - 15 March 2024

Recall alert for Anesketin 100 mg/ml 5ml Solution for Injection - 13 March 2024

Solensia 7 mg/ml Solution for Injection for Cats – SPC change - 8 March 2024

Product defect recall: NARKETAN-10 100mg/ml Solution for Injection - 21 February 2024

Product defect recall: Listed King British Medicines - 21 February 2024

Known supply problems with animal medicines - 2 February 2024

2. Enforcement

Bronchospasmolytic injectable medicines for horses seized - 19 April 2024

Horse dewormer medicine seized - 2 April 2024

AnimalBiome animal supplement seized - 2 April 2024

Animal supplement seized - 2 April 2024

Antibiotics from India seized - 21 March 2024

Six horse worming medicines seized - 21 March 2024

Seizure of unauthorised veterinary medicine for horses - 15 March 2024

Unauthorised horse medicine seized - 8 March 2024

Six C’est Pharma Products Seized - 21 February 2024

Durvet Horse Wormer Seized - 21 February 2024

Non-UK Authorised Animal Medicines Seized - 21 February 2024

Darbelife Injection seized - 21 February 2024

3. AMR

3.1 Policy and Communications

The UK-VARSS Report 2022 was updated on 13 March 2024 to include Chapter 4 – Clinical surveillance of antibiotic resistance. Clinical surveillance aims to provide veterinarians with relevant treatment information using results from bacteria isolated from diagnostic samples. Resistance was usually highest to the most commonly used antibiotics: aminopenicillins and tetracyclines.

3.2 AMR National Action Plan 2024-2029

The AMR National Action Plan 2024-2029 is now published. This action plan is co-owned by DHSC and Defra and has been developed through cross-UK working between the UK Government and Devolved Administrations in Scotland, Wales and Northern Ireland and sets out our comprehensive One Health approach to tackle AMR.

3.3 International Engagement

UNGA AMR High-Level Meeting 2024

VMD and DHSC are continuing with preparations for the AMR High-Level Meeting (HLM) at the UN General Assembly in 2024.

AMR team visit to China - 15 -19 January

With the support of the Global Health team at the British Embassy in Beijing, a joint delegation of technical and policy experts from the Veterinary Medicines Directorate and external academics visited China to engage with Chinese counterparts on technical discussions.

3.4 Surveillance Activities

PATH-SAFE

Sampling has been completed for all of the PATH-SAFE AMR projects. Analysis and write-up of results is underway. The PATH-SAFE programme has been funded to continue for an additional year. This continuation will extend AMR projects on raw pet food, wastewater, and additional bioinformatics work on AMR data. VMD AMR team members attended the PATH-SAFE Biosurveillance conference on 28 and 29 February and presented the various AMR focused projects carried out within PATH-SAFE.

National Biosurveillance Network

Alpha phase will formally commence in April 2024. VMD is working with APHA on one workstream of NBN, to investigate barriers and incentives to AMR data sharing between private veterinary labs and government. This builds upon existing work conducted through the Private Laboratories Initiative (PLI).

Upcoming research call

The AMR Surveillance team are commissioning research to pilot different approaches to surveillance of antibiotic resistance in healthy dogs, cats and horses in the UK. This will contribute to informing the development of representative UK-wide surveillance of antibiotic resistance in healthy companion animals and equines. Details of this upcoming research can be accessed on Contracts Finder.

3.5 Antibiotic Usage and Stakeholder Engagement

The antibiotic use, stewardship and stakeholder engagement team continue to work closely with a range of stakeholders to ensure that the updated Veterinary Medicines Regulations, as they relate to AMR, are fit for purpose and clear. This includes working with stakeholders to develop templates for farm-level management reviews, working with the VMD’s Enforcement Team and developing guidance alongside the legislation.

Since January 2024, the antimicrobial use and stewardship team have developed and delivered veterinary undergraduate training lectures and interactive case studies on AMR and stewardship at 4 different veterinary schools.

3.6 Defra Antimicrobial Resistance Coordination (DARC) – 12 March

The meeting included an update on recent findings from across the UK on AMR in bacteria of importance to animal and public health. An update and discussion on the development of the 2024 to 2029 AMR National Action Plan (NAP) was held and an overview of the EU’s new methods for calculating antimicrobial consumption was given. A guest presenter from UKHSA provided insight into the key findings of a joint UKHSA/APHA project looking into Salmonella from dogs. Additionally, the VMD provided an update on the Veterinary Medicines Regulations. The next meeting is scheduled to take place on 6 June 2024. Minutes from previous meetings are available on GOV.UK.

Antimicrobial resistance (AMR) - 8 April 2024

4. Guidance Updates

Guidance available for product information templates for veterinary medicines - 4 April 2024

Product Information Templates for Veterinary Medicines (SPC and QRD Text) - 4 April 2024

Report a product defect: veterinary medicine - 27 March 2024

Export drugs and medicines: special rules - 19 March 2024

Submission of an application for an animal medicine authorisation - 16 February 2024

Extension to submission slots requirement to include specific MAs - 16 February 2024

Joint RCVS and VMD guidance published - 13 February 2024

Specific Manufacturing Authorisations - 8 February 2024

VMD and HPRA guidance on acceptable text for joint-labelled veterinary medicines in the UK and Ireland - 8 February 2024

Exemption from authorisation for medicines for small pet animals - 5 February 2024

5. Surveillance

Residues of veterinary medicines in food: 2024 - 29 April 2024

Residues of veterinary medicines in food: 2023 - 29 April 2024

6. Statistics

Top Ten Imported Veterinary Medicines – Quarterly Report 1 Jan to 31 Mar 2024 - 23 April 2024

7. Stakeholder Engagement

VICH consultation on new guidelines relating to technical requirements - 15 April 2024

VMD Customer Satisfaction Survey 2023: Improving our service to you - 29 February 2024

VICH Consultation relating to demonstrating the safety of residues in food - 12 February 2024

8. Corporate News

VMD Information Hub - 30 April 2024

Guidance available for product information templates for veterinary medicines - 29 April 2024

Product Literature Standard (PLS) for veterinary medicines - 29 April 2024

Summary of Product Characteristics and product literature for veterinary medicines - 29 April 2024

Veterinary Medicines Directorate – Our governance - 5 April 2024

Recruitment for two Non-Executive Directors - 25 March 2024

Veterinary Antimicrobial Resistance and Sales Surveillance 2022 - 13 March 2024

VMD Published Standards 2023 to 2024: Monitoring performance - 7 March 2024

Government brings in Veterinary Medicines Regulations legislation - 4 March 2024

VMD Collaboration: MSc in Veterinary Medicine Regulatory Affairs - 29 February 2024

Review of the Veterinary Medicines Regulations 2013 - 2 February 2024

New plan published to reform Veterinary Medicines Regulations - 2 February 2024

Veterinary Medicines Directorate framework document - 1 February 2024