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EU Commission authorises first DNA vaccine
Clynav will protect Atlantic salmon against Salmon Pancreas Disease.

Clynav will protect salmon against serious infectious disease

The first veterinary DNA vaccine to protect Atlantic salmon against Salmon Pancreas Disease (SPD) had been authorised across the European Union.

SPD is a serious infectious disease which causes damage to the heart, pancreas and skeletal muscle, leading to death in some cases.
The disease has become established in some Member States and outbreaks cause significant loses in salmon farms.

DNA vaccines consist of a genetic sequence that triggers the production of proteins in the cells of the vaccinated animal. These proteins stimulate a protective immune response, thereby preventing or reducing the impact of the disease should the animal be exposed to the virus.

Clynav, marketed by Elanco Europe Ltd, is the first DNA vaccine to be recommended for marketing authorisation in the EU.

Following a series of successful trials, the EMA’s Committee for Veterinary Medical Products (CVMP) considered that the protection provided by the vaccination is clinically relevant and provides direct benefit to the salmon in terms of improved health and welfare.

The CVMP was also satisfied that any potential risk to the environment from use of the product in salmon was negligible. Furthermore, because residues degrade fast in the gastrointestinal tract, the committee concluded that vaccinated salmon are safe to eat.

The Veterinary Medicines Directorate, who steered the authorisation ‘through challenging regulatory hurdles,’ said that the vaccine ‘has the potential to herald a new ear of novel vaccines to protect animals against disease’.

It added that a full summary of Product Characteristics will soon be available through the EMA website and the VMD’s Product Information Database.

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Defra shares new Sanitary and Phytosanitary guidance

News Story 1
 Defra has published guidance for the vet sector ahead of a proposed UK-EU Sanitary and Phytosanitary agreement.

The agreement, which will change the movement and trade of animals and related products, could see reductions in checks, paperwork and certification. As well as describing regulatory developments, the advice highlights the importance of animal ID, registration and traceability in disease control and other compliance arrangements.

The guidance can be found here. More detail is expected as negotiations progress. 

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News Shorts
New form for online veterinary medicines retailers

The Veterinary Medicines Directorate (VMD) has produced a new online form for retailers wishing to sell veterinary medicines on the internet.

The form replace the previous Word version and is part of the VMD's ongoing commitment to digitise its processes. Anyone retailing prescription medicines online, including POM-V, POM-VPS and NFA-VPS categories, is lawfully required to register with the VMD before trading.

The change only applies to new applicants. Retailers already listed on the VMD's Register of Online Retailers or registered under the Accredited Internet Retailer Scheme (AIRS) do not need to do anything.