Welcome to VMD Connect

Together with our regulatory site www.gov.uk/vmd, find out about what we are working on and the current issues that are important to us all. If you are involved in animal health and welfare – from manufacture to end user – then this site is for you.


VMR - new legislation introduced


The VMD expands evidence base with latest research on pathways of flea and tick treatments

The VMD welcome the publication of Perkins et.al. (2024), which forms part of the body of evidence we are gathering to better understand the levels of imidacloprid and fipronil that have been detected in UK surface waters.  The VMD commissioned this research to investigate the potential environmental exposure pathways for flea and tick products and findings suggest that use of certain topical flea and tick treatments can contribute to levels of imidacloprid and fipronil in the environment, particularly via wastewater. This is considered to be key evidence, which will be taken forward internally as well as by the cross Government Pharmaceuticals in the Environment Group. 

 

The VMD recognise the concerns around this topic, although it is important to highlight that several gaps in our knowledge remain, including developing a better understanding of the contribution to surface water levels from other uses of imidacloprid and fipronil and investigating the extent of harm to ecosystems from these levels. The possible negative impacts on animal health and human health in changing usage patterns of such veterinary medicinal products also need to be considered. 

 

Flea and tick treatments contribute to animal welfare and play an essential role in protecting animals and humans against fleas and ticks and their associated vector-borne diseases. Therefore, it is necessary to take a balanced approach when considering this issue. As the UK government regulator of veterinary medicines, our role is to promote animal health and welfare, as well as protect public health and the environment by assuring the safety, quality and efficacy of veterinary medicines. In order to achieve our objectives, all veterinary medicines undergo rigorous scientific assessments prior to approval, in line with International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines. As part of this process, an environmental exposure assessment is conducted for every veterinary pharmaceutical, referred to as a Phase I exposure assessment. If environmental exposure is thought to be high, an in-depth ‘Phase II’ risk assessment is performed to further evaluate risks to the environment. The findings from this assessment are factored into the decision whether to approve a veterinary medicinal product. At present, pharmaceuticals for companion animals typically end at Phase I, as VICH guidelines stipulate that environmental exposure from use of these types of products will be negligible. Although the VMD acknowledge that there are still several evidence gaps remaining and are working towards filling these gaps, we now consider that there are sufficient data to support a review of the internationally agreed Environmental Risk Assessment guidelines.

 

Whilst the VMD are prioritising the development of evidence based actions around the impacts of veterinary medicines on the environment, working to resolve this issue will require involvement by all key stakeholders, including industry and veterinary professionals. The VMD are aware of various other initiatives and academic research occurring that are evaluating the need for changes to the assessment for non-food animals. We are supportive of these efforts and encourage stakeholders to engage with the VMD in order to facilitate proactive collaboration and move forward with this important issue.

 

There have also been concerns raised regarding the safety of these medicines to humans. As part of the authorisation process, applicants must carry out a user risk assessment, which takes into consideration data on pharmacology and toxicology of the substances included in the product in order to determine the likely hazards to human users (and family members including children, where the products are used in the home), and the likely exposure (routes and extent) of the people involved. These data are then combined in a risk assessment which determines the likely risks and then mitigates for them. The risk mitigations can be in the form of user safety warnings that appear on the product packaging, or in other ways, such as having child-resistant closures.

 

Once a product has been granted a marketing authorisation it is then subject to post marketing surveillance. The Marketing Authorisation Holder has a legal responsibility to report to the VMD any reports of adverse events it receives relating to the use of the product on the animal, any adverse events experienced by those administering the product to the animal or animal owners, any adverse events to the environment and also whether there is a lack of efficacy. Furthermore, we encourage adverse event reporting directly from veterinary surgeons and also from the owners of animals and the general public. As is the case for human medicines, no veterinary medicine is 100% risk-free. Our pharmacovigilance programmes, however, are there to help ensure that the balance between the benefits and risks of authorised medicines remains favourable in order to safeguard animal health and welfare, and human health. The VMD’s pharmacovigilance team continuously monitor all authorised veterinary medicinal products for adverse events by analysing reports received. In light of this information, and the possible signals being detected, the VMD has the power to request changes to how the product is used, and this can also include suspension or revocation of the marketing authorisation. Any change, however, must be supported by data to ensure that the proposed amendments are appropriate and that the benefits of authorising the product continue to outweigh the risks.

 

Based on the data we have received, when considering reported adverse events in humans when compared against the volumes of the products sold, the incidence of adverse events to humans are calculated as:

Active Incidence Rate
Fipronil sprays (cats and dogs) 1 adverse event per 10,000 doses administered.
Fipronil spot-on (cats, dogs) <1 adverse event per 10,000 doses adminitstered
Imidacloprid spot-on (dogs, cats, ferrets) <1 adverse event per 10,000 doses administered.
Imidacloprid collars for dogs <1 adverse event per 10,000 doses administered.

It is important that reports of suspected adverse events are reported to the VMD so that we can continue to monitor the situation for signals that may emerge.

Gov.uk article November 2023

Pharmaceuticals in the Environment cross-government group

The Pharmaceuticals in the Environment (PiE) Group, formed in 2023, is a UK cross-government platform to enable discussion and knowledge exchange relating to pharmaceuticals in the environment from human, veterinary and, where there is cross over, agricultural and non-agricultural sources. 

Membership has grown to include more organisations from across the UK government and devolved administrations.

Currently, membership includes:


  • Veterinary Medicines Directorate (VMD)
  • Environment Agency (EA)
  • Health and Safety Executive (HSE)
  • Department of Environment, Food and Rural Affairs (Defra)
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • Natural Resources Wales/Welsh Government (NRW/WG)
  • Northern Ireland Environment Agency/Department of Agriculture, Environment and Rural Affairs (NIEA/DAERA)
  • Scottish Environment Protection Agency (SEPA)
  • Joint Nature Conservation Committee (JNCC)
  • NHS Highland


At our first meeting, held in April 2023, we agreed our purpose – to develop a co-ordinated strategy to reduce the impacts of pharmaceuticals on the environment (biodiversity) and human health. 


We also identified our first priority area, which is to gain a better understanding of the potential sources of fipronil and imidacloprid levels detected in UK surface waters and to work towards reducing these levels. 


Vet practice & supply

Product information and importing

Find the most current information about all veterinary medicines authorised in the UK. If no suitable product is available find out more about our Special Import Scheme and FAQs.

Adverse events

Vets are one of the most at risk users of veterinary medicines. Find downloadable resources about why it's important to report, what should be reported, and how to do it.

Enforcement

Our primary enforcement approach is through education. Find downloadable text to help combat prescription fraud, and how to manage and dispose of controlled drugs.

Our training centre

We offer training courses for dispensary managers and wholesale dealers. We also collaborate with other organisations in producing training courses and material.

Equine anthelmintic resistance

Equine AR is becoming more wide-spread and of greater significance. Find out more about how we are working with the equine industry.


Monthly Medicines Update

Get the latest information about new marketing authorisations and changes to existing authorisations that relate to the safe use of the product.

Go to Medicines update

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